Frequency of Knee Pain and Risk Factors and Its Impact on Functional Impairment: A Cross-Sectional Study from Saudi Arabia.

BACKGROUND: Adolescents frequently self-report pain, according to epidemiological research. The knee is one of the sites wherein pain is most commonly reported. Musculoskeletal disorders play a significant role in the prolonged disability experienced by individuals, leading to substantial global personal, societal, and economic burdens. Patellofemoral pain (PFP) is a clinical knee pain commonly affecting adolescents. This study aimed to estimate the frequency of knee pain in Saudi adolescents. METHODS: This cross-sectional survey was conducted from June to November 2022 and included 676 adolescents aged 10 to 18 years. The participants were questioned regarding their demographics, school habits, and the impact of these factors on back pain, musculoskeletal pain in the past 12 months, as well as quality-of-life scale and knee pain symptoms. The data were analyzed using descriptive statistics, with frequencies and percentages presented for categorical variables. Analysis of variance (ANOVA) was performed to compare means between groups, while the chi-squared test was used to compare categorical variables. Statistical significance was set at p < 0.05. RESULTS: A total of 676 adolescents participated in the study, with 57.5% females and 42.5% males. Among the participants, 68.8% were aged between 15 and 18 years. The prevalence of knee pain was notably higher among females (26%) compared to males (19.2%). Age and BMI were identified as significant predictors of knee pain. A significant association was also found between BMI classification and knee stiffness (p-value = 0.008). Furthermore, a significant difference was observed between adolescents who engaged in physical activities during leisure time and those who experienced difficulty bending (p-value = 0.03). CONCLUSIONS: Our study highlights a high prevalence of knee pain among Saudi adolescents, emphasizing the need for increased awareness about its risk factors. Preventive measures, including conservative approaches and lifestyle/activity modifications, can effectively mitigate adolescent knee pain.

Correction: Comparison of the Effects of Regular Periods of Immobilization and Prolonged Immobilization on Hand Function Post Distal Radial Fracture.

[This corrects the article DOI: 10.7759/cureus.30986.].

Correction: Hidden Blood Loss in Transforaminal Lumbar Interbody Fusion: An Analysis of Underlying Factors.

[This corrects the article DOI: 10.7759/cureus.35126.].

Percutaneous hydrodiscectomy surgery effectiveness in chronic back pain (hydrodiscectomy in chronic back pain).

OBJECTIVES: To investigate the pre-operative and post-operative characteristics of patients suffering from chronic back and radicular pain who had percutaneous hydrodiscectomy. Hydrodiscectomy is an advanced percutaneous discectomy technique that utilizes a concentrated, high flow water current for the cutting and simultaneous tissue aspiration of the intervertebral disc. METHODS: Retrospective cohort study at a single center. We assessed the eligibility of all patients who had undergone hydrodiscectomy in the orthopedic department of our institution for four years period. Out of 40 eligible patients, a total of 22 patients consented to participate in the study. Study period from March 2017 to February 2022. RESULTS: Fifteen patients were males (68.2%), seven were females (31.8%). Mean age was 45.46 years. Patients had symptoms for a mean of 46.36 months prior to the procedure, and the mean extent of disc bulge was 5.2 mm. 68.2% of the patients reported a reduction in or complete elimination of the back pain and the radicular lower limbs pain following hydrodiscectomy. 95.5% of the patients experienced no pre-, intra-, or post-operative complications. CONCLUSION: Results demonstrate that percutaneous hydrodiscectomy is safe and effective in patients with chronic back and radicular pain due to disc herniation.

Hidden Blood Loss in Transforaminal Lumbar Interbody Fusion: An Analysis of Underlying Factors.

Background In the management of lumbar spine diseases, various techniques have been described for minimizing intraoperative blood loss. Soft tissue extravasation and hemolysis have been referred to as hidden blood loss (HBL). By acknowledging HBL and accounting for it in our postoperative care, strategies of fluid infusion and blood transfusion may be altered. Our study aims to estimate HBL in transforaminal lumbar interbody fusion (TLIF) surgeries and to analyze associated factors. Methods This is a retrospective cohort study. Records of patients who underwent TLIF between January 2016 and December 2020 were reviewed. Patients with both minimally invasive (MIS) and open TLIF were included. Patients with infection, tumors, or fractures being the indication for surgery were excluded. Moreover, patients with known blood-related diseases, aged younger than 18 years, patients requiring blood transfusion, or patients with estimated intra-operative blood loss greater than 1.5 L were excluded. HBL was calculated according to the formulae depending on patients' weight, height, and hematocrit. Statistical analyses were performed to determine associations between HBL and other factors. Results A total of 95 patients were included. The mean estimated blood loss (EBL) was 231 mL, whereas the mean HBL was 265 mL, and the mean total blood loss is 629.7 ml with HBL accounting for 42% of it. Significant associated factors with HBL were the type of surgery, patient's total blood volume, preoperative hemoglobin and hematocrit, and decrease in hemoglobin and hematocrit. Conclusion Significant HBL may occur after TLIF, which was shown to be more than EBL. Although MIS had less EBL, it was associated with more HBL. Patients' preoperative hemoglobin and hematocrit, and a decrease in them, have been shown to be associated with HBL. All these factors should be considered for postoperative management of blood loss.

Marker Screw Utilization for Minimally Invasive Transforaminal Lumbar Interbody Fusion (MS-MIS TLIF): Promises and Advantages.

Background and Objective: Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS-TLIF) has been investigated and shown excellent short- and long-term outcomes. In this paper, we describe a new MIS-TLIF technique and pedicle screw insertion using a marker screw as a guidance method. Moreover, we report perioperative, postoperative, and patient-related outcomes. In addition, this paper outlines major differences in radiation exposure, cost effectiveness and accuracy of Marker Screw Minimally Invasive Transforaminal Interbody Fusion (MS-MIS TLIF) compared to other techniques. We report our technique to share our knowledge and experience with the aim of achieving a better MIS-TLIF that would help both surgeons and patients. Materials and Methods: A prospective case series was conducted between October 2018 and February 2021. Patients undergoing MS-MIS TLIF with marker screws were consecutively included. The surgery did not exceed two levels. The patients' medical records were reviewed, and the included patients were asked to complete two outcome-questionnaires before surgery and at the six-month visit. The surgical technique is described in this paper. Results: A total of 37 patients were recruited. The mean age was 57.35 ± 12.8 years, and more than half of the patients were females. The most common indications for surgery were degenerative disc disease and spondylolisthesis, with the typical level at L4-5. The operative time was 3.02 ± 0.83 h, while the estimated blood loss was 127.7 ± 71.1 mL. The average time for ambulation and hospitalization was 1 ± 1.1 and 2.84 ± 1.4 days, respectively. The patients described significant improvement in both questionnaires. No screw-related complications or screw revisions were needed up to two years of follow-up. Conclusions: The use of marker screws for pedicle screw placement through a minimally invasive fashion is shown to be a promising technique that can overcome many drawbacks, including cost, operative time, and radiation exposure. Performing MS-MIS TLIF can achieve a 360- degree fusion compared to percutaneous MIS-TLIF.

Comparison of the Effects of Regular Periods of Immobilization and Prolonged Immobilization on Hand Function Post Distal Radial Fracture.

Introduction Distal radius fracture (DRF) is one of the most common orthopedic cases managed in the emergency room. DRF treatment is either non-operative or operative. Regardless of the treatment methodology, a period of immobilization of 4-6 weeks is required. Purpose The study aims to evaluate hand function for patients who sustained DRF with different immobilization periods in King Abdul-Aziz Medical City, National Guard Hospital - Jeddah (NGHA) from December 2016 until December 2019. Materials and methods This is a retrospective cohort study where we collected data of DRF patients managed in NGHA. Data was collected directly from NGHA medical records (December 2016-December 2019). A total of 44 patients met the inclusion criteria. Patients were divided into two groups; a group that was immobilized as per protocol (six weeks) and a group that deviated from protocol and immobilization exceeded six weeks. A data collection sheet included the patient's demographics, history, fracture description, management method, and hand function measurements. Results Of the 44 participants, 24 (54%) deviated from protocol; the remaining 20 (46%) were immobilized as per protocol. The prolonged immobilization group had limitations in hand function, restriction in extension (P-value = 0.641), and a decrease in grip strength (P-value = 0.291) compared to the per-protocol group. Flexion and radial deviation were affected similarly in both groups. Conclusion Although the results were not significant, immobilization for more than six weeks is associated with decreased hand function, range of motion (ROM), grip strength, and higher pain scores based on occupational therapy (OT) measurements.

Rapid Deterioration of a Cervical Tuberculosis Disease in a Young Immunocompetent Patient: A Case Report.

Any organ system is prone to extrapulmonary tuberculosis (EPTB) development, including the spine. Spinal TB is a rare involvement, although considered one of the most dangerous forms of skeletal TB (STB). A 31-year-old man, who is a healthcare worker, presented to the outpatient Orthopedic Spine clinic at King Abdulaziz Medical City-Ministry of National Guard Health Affairs (KAMC-MNGHA) Jeddah, Saudi Arabia, with a complaint of axial neck and upper back pain whose condition deteriorated quickly, necessitating urgent admission for surgical treatment in the form of cervical spine decompression and fusion, in addition to the anti-tuberculosis drug (ATD) scheme. Cervical TB is a rare spinal disease that supposedly has a slow, insidious progression. The main presenting symptoms of which are axial and/or radicular pain, with a possible neurological deficit(s). In this particular case, the rapid progression of the disease necessitated rapid action. In spite of what is known about spine TB and its slow progression, the case presented here was beyond our expectations. Treatment planning and urgency should not rely on the known natural history of the disease but rather be tailored to each case individually. This delineates the importance of reporting the quick, unexpected deterioration of our patient's condition.

Scoliosis Associated with Lumbar Spondylolisthesis: Spontaneous Resolution and Seven-Year Follow-Up.

Scoliosis is defined as a structural deformity of the spine in all three dimensions and diagnosed if the Cobb angle is ≥10 degrees. Scoliosis is frequently associated with symptomatic spondylolisthesis, with an incidence ranging from 15% to 48%. The present report describes a patient with scoliosis associated with grade IV lumbar dysplastic spondylolisthesis who experienced the spontaneous correction of scoliosis after spondylolisthesis correction and fixation. The patient was a 12-year-old girl premenarche with an eight-month history of progressively increasing scoliosis, including back pain, left side leg pain, spinal deformity, and abnormal gait. She had been treated with a brace at the referring hospital but without significant improvement. Anteroposterior radiographs showed a long section of the spine, from T2 to L2, curving about 28.8 degrees to her right side, without evident pedicle rotation. Lateral radiographs revealed L5/S1 dysplastic type spondylolisthesis with >75% slippage (Meyerding Grade IV), a dome-shaped sacrum, and a flat back with butterfly sign. Correction of her spondylolisthesis by segmental instrumentation and interbody fusion of L5 and S1 resulted in almost complete resolution of her pain and scoliosis, with the outcome remaining stable seven years after surgery. These findings indicate that patients with scoliosis caused by spondylolisthesis may require only surgery for the latter condition, avoiding unnecessary surgery for scoliosis.

Pedicle screw insertion in the thoracolumbar spine: comparison of 4 guidance techniques in the intact cadaveric spine.

OBJECT: Pedicle screw fixation is a mainstay of thoracolumbar stabilization. Screw insertion using anatomical landmarks and fluoroscopy is common but can be technically challenging and generally involves substantial exposure to ionizing radiation. Computerized navigation has been reported to improve accuracy but is expensive and complex. The authors undertook this study to evaluate these 3 methods in comparison with a fourth technique using standard cervical distractor screws to mark the entry point and trajectory. METHODS: Four cadaveric human spines were used for this study. After an initial CT scan, 34 pedicle screws were inserted in each intact spine from T-1 to L-5 using the following 4 screw insertion guidance techniques (1 technique per specimen): use of anatomical landmarks, use of cervical distractor screws and spot fluoroscopy, fluoroscopy-based navigation, and fluoroscopy- and CT-based navigation (using merged imaging data). Postprocedural CT and anatomical dissection were then performed to evaluate screw position for site and degree of breach. RESULTS: The cervical distractor screw method had a breach rate of 5.9% versus 29.4%, 32.4%, and 20.6% for use of anatomical landmarks, fluoroscopic navigation, and fluoroscopic-CT navigation, respectively (p < 0.05). There is also a significant association between degree of medial and distal breach and the method of screw insertion (p < 0.05). CONCLUSIONS: Cervical distractor screws as pedicle markers offer favorable insertion accuracy and reduction of radiation exposure compared with the other 3 methods used in clinical practice.

Impact of different carbapenems and regimens of administration on resistance emergence for three isogenic Pseudomonas aeruginosa strains with differing mechanisms of resistance.

We compared drugs (imipenem and doripenem), doses (500 mg and 1 g), and infusion times (0.5 and 1.0 [imipenem], 1.0 and 4.0 h [doripenem]) in our hollow-fiber model, examining cell kill and resistance suppression for three isogenic strains of Pseudomonas aeruginosa PAO1. The experiments ran for 10 days. Serial samples were taken for total organism and resistant subpopulation counts. Drug concentrations were determined by high-pressure liquid chromatography-tandem mass spectrometry (LC/MS/MS). Free time above the MIC (time > MIC) was calculated using ADAPT II. Time to resistance emergence was examined with Cox modeling. Cell kill and resistance emergence differences were explained, in the main, by differences in potency (MIC) between doripenem and imipenem. Prolonged infusion increased free drug time > MIC and improved cell kill. For resistance suppression, the 1-g, 4-h infusion was able to completely suppress resistance for the full period of observation for the wild-type isolate. For the mutants, control was ultimately lost, but in all cases, this was the best regimen. Doripenem gave longer free time > MIC than imipenem and, therefore, better cell kill and resistance suppression. For the wild-type organism, the 1-g, 4-h infusion regimen is preferred. For organisms with resistance mutations, larger doses or addition of a second drug should be studied.

Identifying exposure targets for treatment of staphylococcal pneumonia with ceftobiprole.

Ceftobiprole is a cephalosporin with potent activity against methicillin (meticillin)-resistant Staphylococcus aureus (MRSA). In order to treat patients with severe staphylococcal pneumonia, it is important to understand the drug exposure required to mediate the killing of multiple log(10) cells in a preclinical-infection model. We measured drug exposure in terms of the percentage of penetration of the drug into epithelial lining fluid (ELF) and in terms of the time for which the drug concentration was above the MIC (time>MIC) in plasma and ELF. In a murine model of staphylococcal pneumonia, we demonstrated that ceftobiprole penetrated into ELF from the plasma at a median level of nearly 69% (25th to 75th percentile range, 25 to 187%), as indexed to the ratio of values for the area under the concentration-time curve in ELF and plasma. The total-drug times>MIC in ELF that were required to kill 1 log(10) and 2 log(10) CFU/g of lung tissue were 15% and 25% of the dosing interval. We also examined the penetration of ELF by ceftobiprole in volunteers, demonstrating mean and median penetration percentages of 25.5% and 15.3%, respectively (25th to 75th percentile range, 8 to 30%). Attainment rates were calculated for kill targets of 1 log(10) and 2 log(10) CFU/g, taken from the murine model, but using the volunteer ceftobiprole ELF penetration data. The standard dose for ceftobiprole is 0.5 g every 8 h as a 2-h infusion. The attainment rates remained above 90% for 1-log(10) and 2-log(10) CFU/g kill targets at MICs of 1 and 0.5 mg/liter, respectively. Taking the expectation over the distribution of ceftobiprole MICs for 4,958 MRSA isolates showed an overall target attainment of 85.6% for a 1-log(10) CFU/g kill and 79.7% for a 2-log(10) CFU/g kill. It is important to derive exposure targets in preclinical-infection models of the infection site so that these targets can be explored in clinical trials in order to optimize the probability of a good clinical outcome.

A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis.

OBJECTIVES: A clinical study was conducted to compare the efficacy and safety of levofloxacin 750 mg once daily for 5 days to ciprofloxacin twice daily for 10 days for the treatment of complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). METHODS: A multicenter, double-blind, randomized, noninferiority study enrolled subjects with AP or cUTI. Subjects received either levofloxacin 750 mg intravenously or orally once daily for 5 days or ciprofloxacin 400 mg intravenously and/or ciprofloxacin 500 mg orally twice daily for 10 days and were evaluated at end of therapy, posttherapy, and poststudy for microbiologic eradication and clinical outcome. RESULTS: A total of 1109 subjects were enrolled; 619 with confirmed diagnosis of AP or cUTI and a study entry uropathogen with a colony count 10(5) CFU/mL or greater and were included in the modified intent-to-treat population. Five hundred six subjects met all criteria for inclusion and were included in the microbiologically evaluable population. At end of therapy, eradication rates in the modified intent-to-treat population were 79.8% for levofloxacin and 77.5% for ciprofloxacin-treated subjects (95% CI, -8.8% to 4.1%). In the microbiologically evaluable population, eradication rates were 88.3% for levofloxacin and 86.7% for ciprofloxacin-treated subjects (95% CI, -7.4% to 4.2%). Outcomes were comparable for the 2 treatments at posttherapy and poststudy. CONCLUSIONS: This study demonstrates that both drug regimens are safe and effective and that a 5-day course of therapy with levofloxacin, administered at a dose of 750 mg once daily, is noninferior to a 10-day course of therapy with ciprofloxacin for the treatment of AP and cUTI.

Identification and pretherapy susceptibility of pathogens in patients with complicated urinary tract infection or acute pyelonephritis enrolled in a clinical study in the United States from November 2004 through April 2006.

OBJECTIVE: The purpose of this study was to assess the pretherapy microbiology and fluoroquinolone susceptibility of pathogens from 650 patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) as part of a multicenter, randomized, controlled clinical trial. METHODS: In this post hoc analysis of a multicenter, randomized, double-blind study, adults with a clinical diagnosis of cUTI or AP were recruited from 130 community-based and institution-based study centers in the United States from November 2004 through April 2006. Urine and blood culture specimens were identified and tested for susceptibility according to Clinical and Laboratory Standards Institute methods. Presence of a pathogen in the urine culture was confirmed by a colony count of =105 colony-forming units per milliliter. Susceptibility to nonstudy drugs (trimethoprim/sulfamethoxazole [TMP/SMX] and ampicillin) and to study drugs (levofloxacin and ciprofloxacin) was categorized as susceptible, intermediate, or resistant. RESULTS: Six hundred fifty patients (417 women, 233 men; age range, 18-94 years) with a diagnosis of cUTI or AP were recruited. A total of 68.2% patients (224 men, 219 women) were diagnosed with cUTI, and 31.8% (198 women, 9 men), with AP. Most (646/650 [99.4%]) infections were community acquired. The most common pathogen was Escherichia coli (65.6%), although 12.2% of patients had gram-positive pathogens. Testing for susceptibility to ampicillin and TMP/SMX found that 50.1% and 22.1% of gramnegative pathogens were fully resistant to ampicillin and TMP/SMX, respectively. However, 91.9% of isolates were susceptible to levofloxacin and ciprofloxacin, with 6.5% of isolates resistant or intermediately resistant to levofloxacin, and 9.7% of isolates resistant or intermediately resistant to ciprofloxacin at study entry (P < 0.001 [Stuart-Maxwell test]). All isolates resistant to levofloxacin were also resistant to ciprofloxacin, whereas 6 isolates that were fully susceptible to levofloxacin were fully resistant to ciprofloxacin. CONCLUSION: In this study, the level of fluoroquinolone susceptibility of urinary pathogens was high (90.6% in cUTI; 98.1% in AP).

A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis.

OBJECTIVE: A double-blind, noninferiority trial was conducted to establish the safety and efficacy of a once-daily, 5-day course of levofloxacin 750 mg compared to a twice-daily, 10-day course of ciprofloxacin in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This report focuses on subjects with AP. RESEARCH DESIGN AND METHODS: Adult male and female subjects with clinical signs and symptoms of AP and laboratory confirmation of their diagnosis were randomized to receive one dose of levofloxacin 750 mg once daily intravenously (i.v.) or orally and one dose of placebo for 5 days, followed by placebo; or ciprofloxacin 400 mg i.v. and/or 500 mg orally twice daily for 10 days. MAIN OUTCOME MEASURES: The primary, prospectively defined end point was microbiologic eradication at post-therapy (study days 15-22). Secondary outcomes included clinical response and safety and tolerability. RESULTS: In the modified intent-to-treat (mITT) population (levofloxacin 94, ciprofloxacin 98), 83% of levofloxacin-treated and 79.6% of ciprofloxacin-treated subjects achieved microbiological eradication (difference -3.4, 95% CI -14.4%, 7.6%). In the microbiologically evaluable (ME) population (levofloxacin 80, ciprofloxacin 76), 92.5% of levofloxacin-treated vs. 93.4% of ciprofloxacin-treated subjects (difference -0.9, 95% CI -7.1%, 8.9%) achieved microbiologic eradication. Clinical success was achieved in 86.2% vs. 80.6% (mITT) and in 92.5% vs. 89.5% (ME) of levofloxacin-treated and ciprofloxacin-treated subjects, respectively. Escherichia coli was the most commonly isolated uropathogen. Few (2.1%) of the pathogens were fluoroquinolone-resistant. Adverse events (AEs) were similar to those seen previously with both agents. Potential limitations are that this analysis is based on a subset of subjects from a larger study and, because of different durations of therapy, the results may be biased against levofloxacin. CONCLUSIONS: High-dose, short-course therapy with levofloxacin in subjects with AP is at least as effective as standard 10-day therapy with ciprofloxacin.

Study entry microbiology in patients with acute bacterial exacerbation of chronic bronchitis in a clinical trial stratifying by disease severity.

OBJECTIVE: To examine study entry microbiology in patients stratified by disease severity in a clinical trial in acute bacterial exacerbation of chronic bronchitis (ABECB). METHODS: Patients were assigned to differing antibiotic therapies based on stratification by disease severity using parameters including forced expiratory volume in 1 second (FEV(1)) as a percentage of predicted value, number of exacerbations during the previous 12 months, and defined co-morbidities. All patients were required to have sputum Gram stain and culture at study entry. RESULTS: There was no statistically significant difference in overall microbiology between patients with less severe and more severe clinical presentations. Typical ABECB pathogens (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were found in 46.2% (147/318) of patients with less severe presentations and 41.9% (143/341) of patients with more severe presentations. Gram-negative organisms and Staphylococcus aureus were also found in both groups. Pneumococcal susceptibilities to the three antibiotics utilized in the trial revealed marked resistance to azithromycin. Limitations of this analysis include that the clinical trial was designed to examine clinical outcomes rather than microbiology, and that we do not correlate study entry microbiology with clinical outcomes. CONCLUSIONS: Stratification of patients by disease severity did not reveal a statistically significant difference in overall microbiological profile. Gram-negative organisms and S. aureus were recovered even from patients with less severe clinical presentations. Pneumococcal resistance varied with the agent tested. These findings may have implications for the selection of appropriate antibiotic therapy.

Comparison of the adverse event profiles of levofloxacin 500 mg and 750 mg in clinical trials for the treatment of respiratory infections.

OBJECTIVE: To compare safety data with levofloxacin 500 mg and 750 mg from clinical trials for the treatment of respiratory infections. METHODS: We compared adverse event data for levofloxacin 500 mg and 750 mg from clinical trials in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia. Adverse events occurring after the initiation of therapy were classified as treatment-emergent adverse events (TEAE); drug-related adverse events (DRAE) were TEAE assessed by the clinical investigator as definitely/very likely or probably related to levofloxacin therapy. RESULTS: Overall, the safety profile of the two doses was similar but not identical. TEAE occurred in 49.0% (1601/3268) of those treated with 500 mg and in 45.5% (519/1141) of those treated with 750 mg (p = 0.042); the corresponding rates of DRAE were 7.6% (248/3268) and 8.0% (91/1141) (p = 0.699). There was no statistically significant difference in terms of overall TEAE and DRAE rates within each of the three infectious conditions, but there were in specific events, all of which are expected with levofloxacin therapy. The limitations of this analysis include that it utilized a subset of available safety data, that it includes data only from clinical trials, and that we report primarily on events occurring in > or = 2% of patients. CONCLUSIONS: Given similar adverse event profiles and the advantages of higher dose therapy, including shorter courses of therapy and potential impact on preventing resistance, clinicians should consider utilizing the 750 mg dose of levofloxacin when choosing between dosage strengths for treatment of indicated infections.

Levofloxacin 750 mg QD for five days versus amoxicillin/clavulanate 875 mg/125 mg BID for ten days for treatment of acute bacterial exacerbation of chronic bronchitis: a post hoc analysis of data from severely ill patients.

This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50% to 65% of the predicted value plus comorbidities, or > or =4 exacerbations per year. A total of 369 patients were included in the intent-to-treat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were current smokers. At the on-treatment visit, a significantly higher proportion of MA patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P < 0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).

Levofloxacin 750-mg for 5 days for the treatment of hospitalized Fine Risk Class III/IV community-acquired pneumonia patients.

BACKGROUND: The efficacy and safety of 750-mg, 5-day levofloxacin was recently shown to be comparable to 500-mg, 10-day levofloxacin in a randomized, double-blind, multicentre clinical trial for mild-to-severe community-acquired pneumonia (CAP). This subgroup analysis attempted to compare the safety and efficacy of a short-course levofloxacin regimen with traditional levofloxacin dosing for PSI Class III/IV patients. METHODS: This retrospective, subgroup analysis focused on Pneumonia Severity Index Class III and IV patients enrolled in the study. Measurements included clinical and microbiological success rates, adverse events, and symptom resolution by day 3 of therapy. RESULTS: Of the 528 patients in the ITT population, 219 (41.5%) were categorized as PSI Class III/IV and included in this analysis. Among the clinically evaluable patients, 90.8% (69/76) of patients treated with the 750-mg regimen achieved clinical success, compared with 85.5% (71/83) treated with 500-mg levofloxacin (95% CI,-15.9 to 5.4). Eradication rates in the microbiologically evaluable population were comparable for the 750- and 500-mg regimens (88.9% vs 87.5%, respectively; 95% CI,-18.3 to 15.6). Both regimens were well tolerated and had comparable safety profiles. A greater proportion of patients in the 750-mg treatment group experienced resolution of fever (48.4% vs 34.0%; P=.046) and purulent sputum (48.4% vs 27.5%; P=.007) by day 3 of therapy. CONCLUSIONS: The 750-mg, 5-day levofloxacin course achieved comparable clinical and microbiologic efficacy to the 500-mg, 10-day regimen. By day 3 of therapy, a greater proportion of patients in the 750-mg group had objective and subjective resolution of fever. Further research is needed to determine the economic significance of short-course levofloxacin therapy.

A trial of high-dose, short-course levofloxacin for the treatment of acute bacterial sinusitis.

OBJECTIVE: Compare two dosage strengths of levofloxacin in the treatment of acute bacterial sinusitis. STUDY DESIGN AND SETTING: Multicenter clinical trial comparing levofloxacin 750 mg for 5 days vs levofloxacin 500 mg for 10 days. RESULTS: Sinus fluid samples were obtained by antral puncture (59.2%) or by sinus endoscopy (40.8%). Among microbiologically evaluable patients, 91.4% (139/152) of patients receiving levofloxacin 750 mg achieved clinical success vs 88.6% (132/149) of patients receiving levofloxacin 500 mg (95% CI -10.0, 4.2). Clinical success rates by pathogen were above 90% in both treatment groups for the 3 typical pathogens of acute sinusitis: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The safety profile of the 2 dosage strengths was similar. CONCLUSION: Levofloxacin 750 mg for 5 days is noninferior to levofloxacin 500 mg for 10 days. SIGNIFICANCE: Levofloxacin 750 mg for 5 days represents a safe and effective treatment regimen for acute bacterial sinusitis. EBM RATING: A-1b.