A prospective study to evaluate antimicrobial prescribing pattern among admitted patients in hilly Himalayan region of northern India.

BACKGROUND AND AIM: Global scenario of antimicrobial (AM) utilization depicts 20-50% inappropriateness. Majority of the hospital admissions are due to unwanted effects because of non-judicial usage of these drugs. The present study focuses on utilization pattern of antimicrobials (AMs) in a tertiary care hospital in northern India. MATERIALS AND METHODS: A prospective observational study was conducted over a period of one year in seven departments of a tertiary care hospital in hilly Himalayan region. Aim of the study was to analyze the AM utilization pattern using World Health Organization (WHO) indicators and instruments. RESULTS: A total 700 prescriptions were analyzed in the present study. Injectable antibiotics (71%) followed by oral (29%) were most commonly prescribed. Beta lactams (79%) were the most frequently used antibiotic class. Most commonly prescribed AM was Ceftriaxone (30%). Majority of the time AMs were given empirically (44.8%), where most common indication was respiratory infections (42%). Culture and sensitivity tests were done for guiding curative therapy in 34.71% cases. The average duration of patient hospital stay was 8.81 days in the study population. The mean duration of prescribed antimicrobial treatment was 5.12 days. On an average 1.93 AMs were prescribed per patient. AMs were prescribed by International nonproprietary name (INN) in 62.19% of the admissions. The most common AM related adverse drug reaction was gastritis (96%) and skin rash (4%) with Amoxicillin + clavulanic acid being the most common causative agent. Total antimicrobial consumption was 148.24 DDD/100 bed days with Medicine department showing the highest consumption (36.25/100 bed days). CONCLUSION: The present study is the first and largest antimicrobial utilization study in the hilly Himalayan region of northern India. Our study found an urgent need for improvement of prescribing patterns, patient care indicators and strict adherence to standard guidelines.

Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: 1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection 2. To compare the safety and efficacy of standard treatment, Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin in patients with severe COVID-19 infection TRIAL DESIGN: The study is an Open label, Parallel arm design, stratified randomised controlled trial. Patients will be categorised as non-severe or severe based on predefined criteria. Those who satisfy all inclusion criteria and no exclusion criteria in the respective categories, will be randomly assigned to one of the three treatment groups in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. PARTICIPANTS: The trial will be undertaken in a tertiary care center of the country where both Covid and non-Covid patients are getting treated. All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent. Patients will be categorised as non-severe or severe based on predefined criteria. INCLUSION CRITERIA (ALL REQUIRED): 1. Age ≥18 years at time of participation in the study 2. Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3. Symptomatic (severe or non-severe) Covid-19 disease 4. Willingness of study participant to accept randomization to any assigned treatment arm EXCLUSION CRITERIA: 1. Use of medications that are contraindicated with Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin and that cannot be replaced or stopped 2. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine or on Ribavirin 3. Any known contraindication to test drugs such as retinopathy and QT prolongation 4. Known allergic reaction or inability to take orally of Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5. Pregnant or breastfeeding females 6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study or want to participate after enrolment INTERVENTION AND COMPARATOR: Two therapeutic interventions for non-severe category and three for severe category as described below NON-SEVERE TREATMENT ARMS (NS-GROUP): Treatment Arm Drug A Standard Treatment (STNS) B Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STNS) Standard Treatment for non-severe cases (STNS): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. SEVERE GROUP TREATMENT ARMS (S-GROUP): Treatment Arm Drug A Standard Treatment (STs) B Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs) C Lopinavir(200mg) + Ritonavir (50mg) two tablets twice daily+ Ribavirin (1.2g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs)6 Standard Treatment for severe patients (STs): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. MAIN OUTCOMES: Primary endpoints: (1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours. (2) Time to SARS-CoV-2 RT-PCR negative in upper respiratory tract specimen, time to laboratory recovery of each organ involvement. Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity. Outcomes are monitored for 28 days from the time of enrolment into the study OR until the patient is discharged or death whichever is longer. RANDOMIZATION: The randomization will be done using a secured central computer-based randomization using a secure website using a central, computer-based randomisation program in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. BLINDING (MASKING): This is an open labelled study i.e. Study assigned treatment will be known to the research team, the investigators and participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Since it is an exploratory trial as COVID-19 being a new disease, all patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included. TRIAL STATUS: Protocol version:1.0 Recruitment start: June 3rd, 2020 (Ongoing) Recruitment finish (expected): October 31st, 2020 TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI): CTRI/2020/06/025575 . Registration on 03 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

A prospective study on bacteriological profile and antibiogram of postoperative wound infections in a tertiary care hospital in Western Rajasthan.

BACKGROUND: Surgical site infections (SSI) are one of the most common hospital-acquired infections worldwide. SSI are known to increase morbidity, mortality, length of stay in hospital as well as the cost of treatment to the patients. The incidence varies from 1% to 20% among developed countries to as high as 40% in developing world. AIMS: To find the incidence and risk factors, bacteriological profile, and antibiogram for SSI in General Surgery department of a tertiary care hospital in Western Rajasthan. METHODS: Culture and sensitivity of wounds of all the clinically suspected cases of SSI were taken. Bacterial identification and antimicrobial susceptibility were performed according to standard CLSI guidelines. Statistical analysis was done using Microsoft Excel, SPSS 13 software. RESULTS: Among total 609 patients, 102 were clinically suspected SSI and 88 were culture positive. Incidence of SSI was 14.45%. The most common organism was Staphylococcus aureus followed by Klebsiella pneumoniae. Most of the Gram-positive isolates were resistant to penicillin and cephalosporin antibiotics and were moderately susceptible to fluoroquinolones and aminoglycosides. Gram-negative isolates were resistant to beta-lactam and beta-lactam/beta-lactamase inhibitor combination also but were susceptible to fluoroquinolones, aminoglycosides, and carbapenems. RESULTS: Among total 609 patients, 102 were clinically suspected SSI and 88 were culture positive. Incidence of SSI was 14.45%. The most common organism was Staphylococcus aureus followed by Klebsiella pneumoniae. Most of the Gram-positive isolates were resistant to penicillin and cephalosporin antibiotics and were moderately susceptible to fluoroquinolones and aminoglycosides. Gram-negative isolates were resistant to beta-lactam and beta-lactam/beta-lactamase inhibitor combination also but were susceptible to fluoroquinolones, aminoglycosides, and carbapenems. CONCLUSION: High incidence rate of SSI in our setup emphasizes the need of quality surgical care which takes into consideration all the three important factors, i.e. host, environmental, and microorganism characteristics before doing any surgery. Increasing resistance to commonly used antibiotics warrants the judicious use of antibiotics and establishment of antibiotic policy in the hospital.

A Narrative Review of Potential Future Antidiabetic Drugs: Should We Expect More?

Prevalence of diabetes mellitus, a chronic metabolic disease characterized by hyperglycemia, is growing worldwide. The majority of the cases belong to type 2 diabetes mellitus (T2DM). Globally, India ranks second in terms of diabetes prevalence among adults. Currently available classes of therapeutic agents are used alone or in combinations but seldom achieve treatment targets. Diverse pathophysiology and the need of therapeutic agents with more favourable pharmacokinetic-pharmacodynamics profile make newer drug discoveries in the field of T2DM essential. A large number of molecules, some with novel mechanisms, are in pipeline. The essence of this review is to track and discuss these potential agents, based on their developmental stages, especially those in phase 3 or phase 2. Unique molecules are being developed for existing drug classes like insulins, DPP-4 inhibitors, GLP-1 analogues; and under newer classes like dual/pan PPAR agonists, dual SGLT1/SGLT2 inhibitors, glimins, anti-inflammatory agents, glucokinase activators, G-protein coupled receptor agonists, hybrid peptide agonists, apical sodium-dependent bile acid transporter (ASBT) inhibitors, glucagon receptor antagonists etc. The heterogeneous clinical presentation and therapeutic outcomes in phenotypically similar patients is a clue to think beyond the standard treatment strategy.