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1.
Entropy (Basel) ; 26(6)2024 May 28.
Article in English | MEDLINE | ID: mdl-38920470

ABSTRACT

Quantum computing (QC) has opened the door to advancements in machine learning (ML) tasks that are currently implemented in the classical domain. Convolutional neural networks (CNNs) are classical ML architectures that exploit data locality and possess a simpler structure than a fully connected multi-layer perceptrons (MLPs) without compromising the accuracy of classification. However, the concept of preserving data locality is usually overlooked in the existing quantum counterparts of CNNs, particularly for extracting multifeatures in multidimensional data. In this paper, we present an multidimensional quantum convolutional classifier (MQCC) that performs multidimensional and multifeature quantum convolution with average and Euclidean pooling, thus adapting the CNN structure to a variational quantum algorithm (VQA). The experimental work was conducted using multidimensional data to validate the correctness and demonstrate the scalability of the proposed method utilizing both noisy and noise-free quantum simulations. We evaluated the MQCC model with reference to reported work on state-of-the-art quantum simulators from IBM Quantum and Xanadu using a variety of standard ML datasets. The experimental results show the favorable characteristics of our proposed techniques compared with existing work with respect to a number of quantitative metrics, such as the number of training parameters, cross-entropy loss, classification accuracy, circuit depth, and quantum gate count.

2.
Entropy (Basel) ; 25(11)2023 Oct 31.
Article in English | MEDLINE | ID: mdl-37998195

ABSTRACT

The convolution operation plays a vital role in a wide range of critical algorithms across various domains, such as digital image processing, convolutional neural networks, and quantum machine learning. In existing implementations, particularly in quantum neural networks, convolution operations are usually approximated by the application of filters with data strides that are equal to the filter window sizes. One challenge with these implementations is preserving the spatial and temporal localities of the input features, specifically for data with higher dimensions. In addition, the deep circuits required to perform quantum convolution with a unity stride, especially for multidimensional data, increase the risk of violating decoherence constraints. In this work, we propose depth-optimized circuits for performing generalized multidimensional quantum convolution operations with unity stride targeting applications that process data with high dimensions, such as hyperspectral imagery and remote sensing. We experimentally evaluate and demonstrate the applicability of the proposed techniques by using real-world, high-resolution, multidimensional image data on a state-of-the-art quantum simulator from IBM Quantum.

3.
High Alt Med Biol ; 24(4): 296-301, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37527184

ABSTRACT

Dangi, Meenu, Arnab Sadhukhan, Poninder Kumar, S. Bandopadhayay, Vijay K. Sharma, V.K. Patra, Manu Chaudhary, and Vipin Rana. Retinal manifestations in high altitude. High Alt Med Biol. 24:296-301, 2023. Aim: To study the high altitude (HA)-related retinal manifestations among security personnel and thus to provide new insights into the characteristics and mechanisms of retinopathy. Materials and Methods: This was a multicentric, nonrandomized prospective observational and descriptive study. We studied 54 security personnel over 1 year, who were referred from HA areas of northern India and north-eastern India for ocular problems. Complete coagulation profile was performed among patients with vascular occlusion. Results: There were total of 54 patients with ages ranging from 22 to 55 years. HA retinopathy was noticed in 28 patients: central retinal vein occlusion (6 patients), branch retinal vein occlusion (4 patients), branch retinal artery occlusion (1 patient), central retinal artery occlusion (4 patients), ocular ischemic syndrome (1 patient), central serous chorioretinopathy (7 patients), acetazolamide-induced maculopathy (1 patient), and solar retinopathy (2 patients). Along with an increased hematocrit, serum homocysteine was raised in the majority of vascular occlusions. The mean age was 38.16 years, the mean altitude was 14,716 ft, and the mean duration of stay was 11.2 weeks. Conclusion: Hypobaric hypoxia due to HA is a potential risk for HA retinopathy and associated vascular occlusions. Aside from increased hematocrit, hyperhomocysteinemia is a potential cause of vascular occlusions.


Subject(s)
Retinal Artery Occlusion , Retinal Vein Occlusion , Adult , Humans , Altitude , Hypoxia/complications , India , Retinal Artery Occlusion/etiology , Retinal Vein Occlusion/complications
4.
Pharmacol Res Perspect ; 10(4): e00979, 2022 08.
Article in English | MEDLINE | ID: mdl-35762448

ABSTRACT

Currently, several biosimilars of low-molecular-weight heparins (LMWHs) with differing potencies are being developed and marketed globally. Thus, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule. The present study aimed to determine the bioequivalence of biosimilar (Cloti-Xa™) and innovator (Clexane® ) formulations of enoxaparin sodium (40 mg/0.4 ml) in healthy human volunteers. It was conducted as a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic study (NCT05265676). The participants were sequentially and randomly administered subcutaneous injections of Cloti-Xa™ (test) and Clexane® (reference), separated by a one-week washout period. To assess the Anti-Xa & Anti-IIa activities, tissue factor pathway inhibitor (TFPI) release and activated partial thromboplastin time (aPTT), blood samples were obtained at various timepoints upto 24 h after the drug administration. Bioequivalence was concluded if the two-sided 90% CI for the test to reference ratio of the population is within 80%-125% for each of the Ln-transformed values of Amax and AUECt for Anti-Xa and Anti-IIa. TFPI and aPTT data were submitted as supportive evidence. The study sample consisted of twenty-four male participants. The 90% CIs of Amax and AUECt for Anti-Xa activity were 105.50%-113.90% and 103.97%-112.08%, and for Anti-IIa activity were 106.56%-117.90% and 107.35%-124.86%, respectively. In addition, the 90% CI of the ratio of Anti-Xa/Anti-IIa activity falls within the acceptance criteria. TFPI and aPTT profiles were similar for both products. No serious adverse events were observed during the study. Conclusively, the results showed that Cloti-Xa™ and Clexane® are bioequivalent and well-tolerated.


Subject(s)
Biosimilar Pharmaceuticals , Enoxaparin , Biosimilar Pharmaceuticals/adverse effects , Enoxaparin/adverse effects , Enoxaparin/analogs & derivatives , Healthy Volunteers , Heparin, Low-Molecular-Weight , Humans , Male , Randomized Controlled Trials as Topic , Therapeutic Equivalency
5.
Antibiotics (Basel) ; 10(4)2021 Mar 28.
Article in English | MEDLINE | ID: mdl-33800696

ABSTRACT

Despite the crucial role of Polymyxin-B in treating life-threatening gram-negative infections, its clinical utility is limited due to the risk of acute kidney injury. In response, a novel formulation of polymyxin-B is being developed to mitigate drug-induced kidney injury. In this study, we have assessed the toxicity of four variants of that novel formulation (VRP034_F21-F24) in comparison with standard polymyxin-B using kidney injury biomarkers in rats. Sprague-Dawley rats were subcutaneously administered either polymyxin-B (control) or one of the four polymyxin-B formulations at a dose of 25 mg/kg/day (HED: 4 mg/kg/day) in four divided doses for two days. Serum samples were collected at baseline and at the end of day 2 for the determination of serum biomarkers. Necropsy was done on day 2 and kidney was collected for histopathological evaluation. In the control group, statistically significant increase (p < 0.0001) in all biomarkers was observed on day 2 as compared to baseline values [urea: 311%; creatinine: 700%; KIM-1: 180%; cystatin-C: 66%] and 50% of the animals died (one after the 7th dose and two after the 8th dose) before scheduled necropsy. In contrast, animals treated with novel formulations did not show a significant increase across any of the biomarkers and no mortality was observed. Histopathology of the control group kidney confirmed necrotic changes in tissues with congestion and vacuolization, whereas only minor tubular damage was noted in two formulation groups (VRP034_F21, F24) and no appreciable damage was detected in the other two groups (VRP034_F22-23). The novel formulation of polymyxin-B tested in this study significantly reduced the risk of polymyxin-induced kidney injury in rats.

6.
J Clin Orthop Trauma ; 11(2): 328-331, 2020.
Article in English | MEDLINE | ID: mdl-32099306

ABSTRACT

Septic Arthritis of the wrist is rare in the paediatric population due to its extraarticular metaphysis. We report here a case of wrist septic arthritis in a neonate caused by an uncommon causative organism, Streptococcus cristatus. A 15 days old male child was referred with the complaint of swelling and decreased movement of the left wrist for 5 days. Local examination revealed warm, tender, erythematous and fluctuant swelling over the dorso-ulnar aspect of the left wrist. Ultrasonography of the affected region was suggestive of focal fluid collection in the wrist and periosteal elevation of the distal ulna. Aspiration followed by arthrotomy of the wrist joint was performed and multiple holes were made in the distal ulnar metaphysis using 0.8mm k-wire. The pus culture was positive for Streptococcus cristatus, sensitive to vancomycin, which was given for a total of 4 weeks. At one year follow up the child had a full, painless range of motion with no functional deficit. Final follow up x rays of the left wrist were normal. Streptococcus cristatus strains are described as Gram-positive, catalase-negative cocci, approximately 1 µm in diameter growing in chains and were originally isolated from the human throat and oral cavities. Its association with bone and joint infections has not been described in the literature. To our knowledge, this is the first case of isolated septic arthritis of wrist in a 15 days old child caused by Streptococcus cristatus. To conclude, wrist septic arthritis in a neonate is a rare entity. With the advanced diagnostics, species-level identification of rare organism like Streptococcus cristatus is possible along with antibiotic sensitivity for appropriate therapy. Early surgical decompression and intravenous culture-directed antibiotics are the mainstays of management.

7.
Water Environ Res ; 91(1): 69-74, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30682227

ABSTRACT

In the present work, the degradation of metanil yellow, an azo dye, by hexacyanoferrate(III) ions (oxidant) in the aqueous alkaline medium has been investigated by kinetic-spectrophotometric method at λmax 435 nm of the reaction mixture. The effect of various parameters such as the concentration of dye, oxidant, and solution pH on the reaction rate has been determined. The results show that the rate of degradation increases linearly with the increase in concentrations of oxidant and dye at optimum pH of 9.0 and constant temperature of 40 ± 0.1°C. Thermodynamic parameters such as energy of activation, enthalpy of activation, entropy of activation, and energy of formation have been calculated by studying the reaction rate at four different temperatures, that is, 40-55°C. Based on the experimental results, a plausible reaction mechanism involving complex formation has been proposed and a rate law has been derived. UV-Vis and LC-MS methods of analysis of degradation products show the formation of simpler and less hazardous degradation products. PRACTITIONER POINTS: It is also observed that the time required for azo dye degradation by the present method is about ten times less than the reported methods. Thus degradation of azo linkage and formation of simple and less hazardous products (efficient degradation of dye) makes it a novel method.


Subject(s)
Azo Compounds/chemistry , Azo Compounds/isolation & purification , Coloring Agents/chemistry , Coloring Agents/isolation & purification , Ferrocyanides/chemistry , Water Pollutants, Chemical/chemistry , Water Pollutants, Chemical/isolation & purification , Industrial Waste/analysis , Kinetics , Oxidation-Reduction , Textiles , Thermodynamics , Water/chemistry
8.
J Glob Infect Dis ; 10(4): 188-195, 2018.
Article in English | MEDLINE | ID: mdl-30581259

ABSTRACT

OBJECTIVE: The aim of this study was to determine the clinical outcome, microbiological outcome and safety profile of CSE-1034, a novel combination of Ceftriaxone, Sulbactam and EDTA in patients with complicated urinary tract infections (cUTI). MATERIALS AND METHODS: This was a randomized, controlled, open-labeled Phase-3 trial with the primary objective of assessing the efficacy and safety of CSE-1034 versus Ceftriaxone for the empirical treatment of cUTI. Adult cUTI patients were randomized to receive either intravenous dose of CSE-1034 or Ceftriaxone. The primary end point was composite cure rate (clinical response and bacterial eradication) in mMITT population at test of cure (TOC) visit. Secondary measures included verification of primary endpoint across other visits in different population sets, safety of patients and treatment duration. RESULTS: Overall, 204 patients were enrolled in the study and received one of the two treatments. At primary endpoint (TOC visit), the composite cure rate was much higher in CSE-1034 treatment arm compared to Ceftriaxone arm i.e. 97% (68/70) vs 83% (58/71) (treatment difference 12.6%; 95% CI: 5.9% to 26.4%). The adverse events (AEs) rates reported in two treatment arms were 21% in CSE-1034 and 36% in Ceftriaxone groups. Additionally, the treatment duration in CSE-1034 arm was significantly less (P < 0.05). CONCLUSIONS: CSE-1034 3 g every 24 h showed a high favorable clinical and bacteriological response, and 95% CI around the treatment difference prove the superiority of CSE-1034 vs. Ceftriaxone for the treatment of cUTI. Therefore, CSE-1034 provides an effective alternative in the treatment of patients with cUTI.

9.
J Infect Public Health ; 11(5): 691-697, 2018.
Article in English | MEDLINE | ID: mdl-29803638

ABSTRACT

OBJECTIVE: CSE-1034 is a novel antibiotic adjuvant entity (AAE) with proven activity against broad range of multi-drug resistant (MDR) pathogens causing various bacterial infections. This phase 3 clinical trial was designed to evaluate the efficacy and safety of CSE-1034 therapy for the treatment of community-acquired pneumonia (CAP) patients of Pneumonia Outcomes Research Team (PORT) risk III-IV. METHODS: In this multi-centric, controlled, open-labeled phase 3 trial, adult patients with PORT risk III-IV CAP were randomized to receive either intravenous CSE-1034 (3g every 12h) or Ceftriaxone (2g every 12h) for 3-10 days. The primary endpoint was clinical response in clinically-evaluable (CE) population and microbiological eradication in microbiologically-evaluable (ME) population at test of cure (TOC) visits. Secondary endpoints included verification of the primary endpoints across all other visits, treatment duration and safety of patients. RESULTS: 156 patients were screened at 5 study centers of which 93 subjects were enrolled in the study and randomized in CSE-1034 and Ceftriaxone treatment arms. In CE population (n=90), the clinical cure rates at TOC visit were 96% and 64% in CSE-1034 (n=46) and Ceftriaxone (n=44) treatment arms respectively (treatment difference: 32.0%; 95% CI, 15.8%-47.1%). The bacterial eradication in ME population of two treatment arms were 94% (n=36) and 56% (n=27) at TOC visit (treatment difference: 38.9%; 95% CI, 17.8%-57.6%). Overall, the total number of adverse events (AEs) reported in both groups were 21 (22.5%). The AEs rates reported in two treatment arms were 15.2% in CSE-1034 and 29.8% in Ceftriaxone group. CONCLUSION: Overall assessment of clinical cure rate, microbiological eradication rate and safety assessment in this study has shown that CSE-1034 is an effective and safe option for the treatment of CAP patients of PORT risk III-IV. Moreover, the superiority of CSE-1034 over Ceftriaxone is also proven.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Community-Acquired Infections/drug therapy , Pneumonia/drug therapy , Administration, Intravenous , Adolescent , Adult , Aged , Ceftriaxone/administration & dosage , Ceftriaxone/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Humans , Male , Middle Aged , Treatment Outcome , Young Adult
10.
Pediatr Infect Dis J ; 37(6): e175-e177, 2018 06.
Article in English | MEDLINE | ID: mdl-29088024

ABSTRACT

Group B streptococcal rectovaginal colonization prevalence in women of Indian descent living in the United States was 24.7% comparable with US rates but higher than rates reported from India. The capsular polysaccharide types were distinct in that type V was most common and 33% of group B streptococcal strains were nontypeable.


Subject(s)
Bacterial Capsules/classification , Carrier State/ethnology , Streptococcal Infections/ethnology , Adolescent , Adult , Carrier State/microbiology , Female , Genotype , Humans , India/ethnology , Middle Aged , Pregnancy , Pregnancy Complications, Infectious/ethnology , Pregnancy Complications, Infectious/microbiology , Prevalence , Rectum/microbiology , Serotyping , Streptococcal Infections/microbiology , Streptococcus agalactiae/classification , Streptococcus agalactiae/isolation & purification , United States/epidemiology , Vagina/microbiology , Young Adult
11.
Braz. j. infect. dis ; 21(4): 408-417, July-Aug. 2017. tab
Article in English | LILACS | ID: biblio-888893

ABSTRACT

Abstract Objective: In India, Elores (CSE-1034: ceftriaxone + sulbactam + disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. Methods: This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. Results: A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. Conclusion: In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings.


Subject(s)
Humans , Child , Adult , Aged , Gram-Positive Bacterial Infections/microbiology , Gram-Negative Bacterial Infections/microbiology , Gram-Negative Bacteria/drug effects , Gram-Positive Bacteria/drug effects , Ceftriaxone/administration & dosage , Ceftriaxone/adverse effects , Sulbactam/administration & dosage , Sulbactam/adverse effects , Gram-Positive Bacterial Infections/drug therapy , Gram-Negative Bacterial Infections/drug therapy , Edetic Acid/administration & dosage , Edetic Acid/adverse effects , Drug Resistance, Bacterial , Drug Combinations , Disk Diffusion Antimicrobial Tests , Gram-Negative Bacteria/classification , Gram-Positive Bacteria/classification , India , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/chemistry
12.
Braz J Infect Dis ; 21(4): 408-417, 2017.
Article in English | MEDLINE | ID: mdl-28376315

ABSTRACT

OBJECTIVE: In India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. METHODS: This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. RESULTS: A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. CONCLUSION: In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings.


Subject(s)
Gram-Negative Bacteria/drug effects , Gram-Negative Bacterial Infections/microbiology , Gram-Positive Bacteria/drug effects , Gram-Positive Bacterial Infections/microbiology , Adult , Aged , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/chemistry , Ceftriaxone/administration & dosage , Ceftriaxone/adverse effects , Child , Disk Diffusion Antimicrobial Tests , Drug Combinations , Drug Resistance, Bacterial , Edetic Acid/administration & dosage , Edetic Acid/adverse effects , Gram-Negative Bacteria/classification , Gram-Negative Bacterial Infections/drug therapy , Gram-Positive Bacteria/classification , Gram-Positive Bacterial Infections/drug therapy , Humans , India , Sulbactam/administration & dosage , Sulbactam/adverse effects
13.
Pharmacol Rep ; 69(1): 176-184, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27923162

ABSTRACT

BACKGROUND: Inflammation in the affected region, increased intracranial pressure, consequent oedema and congestion contribute to the negative outcome of traumatic brain injury. Osmotic therapies are recommended for improvement in cognitive and motor functions. Aim of the present study was to evaluate the effect of osmotic therapies in a mice model of traumatic brain injury. METHODS: Experimental closed head injury was performed in adult Swiss albino mice by the weight-drop method. Different group of animals were treated with normal saline (G1), mannitol (G2), mannitol+glycerin (G3) and Neurotol (G4). Neurological Severity Score (NSS) was recorded at different time-points upto a period of six days. Effect of treatments on cerebral oedema, learning and memory function, motor function and co-ordination were evaluated by gravimetry, Morris water maze and beam walk test respectively. Histopathology was performed to evaluate the treatment effects on microscopic complications arising from primary closed head injury (CHI). RESULTS: All the treatments showed a marked improvement in the evaluated parameters as compared with the vehicle control group. It was evident that G3 and G4 had a distinct advantage over mannitol therapy. Based on the NSS score, Neurotol proved to be comparatively safe and more efficacious than either mannitol or a combination of mannitol+glycerol. The effect of Neurotol could have been enhanced by the presence of VRP011 (a Mg+2 salt). CONCLUSIONS: Neurotol is safe and exhibits better efficacy as compared with other treatments for the management of traumatic brain injury.


Subject(s)
Brain Injuries, Traumatic/drug therapy , Carbamazepine/therapeutic use , Disease Models, Animal , Osmosis/drug effects , Animals , Brain Injuries, Traumatic/pathology , Brain Injuries, Traumatic/physiopathology , Carbamazepine/pharmacology , Male , Maze Learning/drug effects , Maze Learning/physiology , Mice , Osmosis/physiology
14.
Pediatr Infect Dis J ; 36(7): 665-669, 2017 07.
Article in English | MEDLINE | ID: mdl-28027278

ABSTRACT

BACKGROUND: Little is known regarding maternal group B streptococcal (GBS) colonization prevalence and capsular (CPS) serotype distribution among pregnant women in India. The objective of this prospective cohort study was to determine GBS recto-vaginal colonization prevalence in pregnant women at Dr. Ram Manohar Lohia Hospital in Delhi, India. METHODS: Literature review identified reports from India assessing GBS colonization prevalence in pregnant women. Rectal and vaginal swabs were inoculated into Strep B Carrot Broth (Hardy Diagnostics, Santa Maria, CA) and subcultured onto GBS Detect plates (Hardy Diagnostics, Santa Maria, CA). Isolates were serotyped using ImmuLex Strep-B latex kits (Statens Serum Institut, Copenhagen, Denmark). RESULTS: Thirteen studies were identified citing GBS colonization prevalence during pregnancy as 0.47%-16%. Among 300 pregnant women (mean age: 26.9 years; mean gestation: 34 weeks) enrolled (August 2015 to April 2016), GBS colonization prevalence was 15%. Fifteen percent of women had vaginal only, 29% had rectal only and 56% had both sites colonized. CPS types were Ia (13.3%), Ib (4.4%), II (20%), III (22.2%), V (20%) and VII (6.7%); 13.3% were nontypable. Fetal loss in a prior pregnancy at ≥20-weeks gestation was more common in colonized than noncolonized women (15.6% vs. 3.5%; P = 0.004). Employing recent census data for the birth cohort and estimating that 1%-2% of neonates born to colonized women develop early-onset disease, at least 39,000 cases of early-onset disease may occur yearly in India. CONCLUSIONS: Using optimal methods, 15% of third trimester pregnant women in India are GBS colonized. A multivalent vaccine containing 6 CPS types (Ia, Ib, II, III, V and VII) would encompass ~87% of GBS carried by pregnant women in India.


Subject(s)
Carrier State/epidemiology , Carrier State/microbiology , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/microbiology , Streptococcal Infections/epidemiology , Streptococcal Infections/microbiology , Streptococcus agalactiae , Adult , Female , Humans , India , Pregnancy , Prevalence , Prospective Studies , Rectum/microbiology , Serogroup , Streptococcus agalactiae/classification , Streptococcus agalactiae/isolation & purification , Vagina/microbiology , Young Adult
15.
Pediatr Infect Dis J ; 35(11): 1269-1270, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27348553

ABSTRACT

We present a case of hepatic abscess in a transfusion-dependent 16-year-old patient with sickle cell disease. There have been 10 such cases in sickle cell disease patients reported, with the last report published greater than a decade ago. The diagnosis of hepatic abscess merits consideration in sickle cell disease patients presenting with fever without a source and/or abdominal pain.


Subject(s)
Anemia, Sickle Cell , Liver Abscess , Adolescent , Fusobacterium , Fusobacterium Infections , Humans , Male
16.
AAPS PharmSciTech ; 17(5): 1192-203, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26644225

ABSTRACT

Increased antibacterial resistance (ABR) and limited drug discovery warrant optimized use of available antibiotics. One option is to rationally combine two antibiotics (fixed dose combination (FDC)) that may delay or prevent emergence of ABR in notorious pathogen. Major concern with FDC is the mutual interaction of its components that might influence their pharmacokinetic (PK) profile, requiring reassessing of whole formulation (adding cost and time). The interaction can be identified by comparing PK profile of a drug present in FDC with its independent entity. An open-label, crossover, single-dose comparative PK study of FDC (ceftriaxone and sulbactam) with their individual reference formulations was performed in 24 healthy adult subjects. No mutual PK interactions between ceftriaxone and sulbactam were observed. Pharmacokinetic data was used to develop a population-PK model to understand between-subject variability (BSV). Pharmacokinetics of ceftriaxone/sulbactam was explained by one and two compartment models, respectively. The subject's "weight" was identified as a covariate explaining BSV. Both internal and external validations (healthy/infected subjects) were done. The model-derived population-PK parameters of FDC's active components in infected subjects were similar to literature reported values of individual components. Efficacies of various FDC dosage regimens over a range of minimum inhibitory concentrations (MICs) were assessed by Monte Carlo simulations using population-PK parameters of infected/healthy subjects. In infected subjects, 3 g FDC/24 h can treat bacteria with MIC ≤8 µg/mL, while for MIC 8-32 µg/mL, 3 g FDC/12 h is recommended. Lastly, the developed population-PK model was successfully used to predict drug exposure in pediatric population.


Subject(s)
Ceftriaxone/administration & dosage , Ceftriaxone/pharmacokinetics , Sulbactam/administration & dosage , Sulbactam/pharmacokinetics , Adult , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/pharmacokinetics , Chemistry, Pharmaceutical/methods , Cross-Over Studies , Drug Combinations , Female , Healthy Volunteers , Humans , Male , Microbial Sensitivity Tests/methods , Middle Aged , Young Adult
18.
Asian Pac J Trop Med ; 7S1: S217-23, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25312124

ABSTRACT

OBJECTIVE: To study the prevalence of extended-spectrum ß-lactamases (ESBLs) among 663 clinical isolates obtained from various parts of India and to study the occurrence of different variants of ESBLs among these isolates. METHODS: Phenotypic characterization and susceptibility studies were performed according to the methods described in Clinical and Laboratory Standards Institute guidelines. The occurrence of ESBL variants was analyzed with PCR using the previously reported primers. RESULTS: Among the six hundred sixty three isolates, the identified isolates were Acinetobacter baumannii (72), Escherichia coli (218), Klebsiella pneumoniae (30), Klebsiella oxytoca (63), Pseudomonas aeruginosa (264) and Staphylococcus aureus (16). PCR results revealed that approximately 89.0% of Pseudomonas aeruginosa isolates were positive for ESBL followed by Escherichia coli (85.3%), Klebsiella pneumoniae (76.6%), Klebsiella oxytoca (73.0%), Acinetobacter baumannii (72.2%) and Staphylococcus aureus (31.2%). The overall prevalence of ESBL was 82.5%. The presence of TEM type ESBLs were the predominant (in 186 isolates), followed by SHV (138), OXA (92), CTX-M (65), AmpC (33), KPC (28) and blaZ (5). Of the drugs involved in the study, CSE1034 was found to be the most efficacious against all of ESBL positive clinical isolates showing susceptibility approximately 95.7% with minimal inhibitory concentration values between 0.125 and 8.000 µg/mL for all strains tested. The susceptibilities of penems (meropenem and imipenem and cilastatin) ranged between 83% and 93% for all the isolates. The susceptibilities of other drugs like piperacillin and tazobactam, amoxicillin and clavulanic acid, cefoperazone and sulbactam were <45% for all the isolates. CONCLUSIONS: Results of the present study indicated that majority of the isolates was susceptible to CSE1034 and it could be a potent antibacterial agent for the treatment of severe bacterial infections caused by such organisms.

19.
Clin Pediatr (Phila) ; 53(11): 1069-76, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24807976

ABSTRACT

BACKGROUND: Ethanol lock therapy (ELT) with systemic antimicrobial therapy (SAT) is a treatment for catheter-associated bloodstream infections (CABSI). However, its impact on hospital length of stay (LOS) is unknown. OBJECTIVES: Assess the impact of ELT on LOS, LOS attributable to CABSI (ALOS), and catheter salvage in pediatric hematology, oncology, stem cell transplant (HOSCT) CABSI. METHODS: Retrospective review of HOSCT CABSI from January 2009 to July 2011. RESULTS: A total of 124 CABSI episodes were reviewed in 66 patients. Mean LOS with ELT after 1 positive blood culture (BC) was 7.1 versus 12.3 days after ≥2 positive BC (P = .014). Mean ALOS was 1.6 days with ELT versus 2.9 days without ELT (P = .018). Mean ALOS with ELT after 1 positive BC was 3.75 days versus 5.8 days after ≥2 positive BC (P = .022). Catheter salvage rate: 41 of 48 (85%) with ELT versus 49 of 68 (72%) without ELT (P = .169). CONCLUSION: Earlier initiation of ELT may decrease ALOS.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Bacteremia/drug therapy , Catheter-Related Infections/complications , Catheter-Related Infections/drug therapy , Catheterization, Central Venous/adverse effects , Ethanol/administration & dosage , Length of Stay/statistics & numerical data , Anti-Infective Agents, Local/administration & dosage , Bacteremia/etiology , Catheters, Indwelling/adverse effects , Cohort Studies , Humans , Michigan , Retrospective Studies , Treatment Outcome
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