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Levofloxacin - ClinicalTrials.gov

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Last Updated: 08 June 2022

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A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer

"Infected skin ulcers in diabetic patients can be very painful and are impossible to heal," says the author. The gentamicin-collagen sponge is a thin flat sponge made of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but little is absorbed into the blood stream, but not much is absorbed into the blood stream. The infection can be treated by the high prevalence of gentamicin in the open infected ulcer. During daily wound care, patients who are randomly assigned to the gentamicin-collagen sponge therapy group will be given a gentamicin-collagen sponge to cover their ulcer. Subjects who are randomly assigned to the oral levofloxacin therapy group will continue to provide daily wound care, but not with the gentamicin-collagen sponge.

Source link: https://clinicaltrials.gov/ct2/show/NCT00593567


Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

"Multidrug-resistant tuberculosis is tuberculosis that is resistant to both isoniazid and rifampicin, the two most commonly used drugs in treating tuberculosis. " Given the long-term and toxicities of MDR-TB drugs, it is perhaps surprising that WHO says that only 25% of patients with MDR-TB are enrolling in WHO-approved treatment regimens, which is perhaps surprising. The earliest period of linezolid-related neuropathy occurs in linezolid-related neuropathy, according to the DRAMATIC regimen, limiting the administration of linezolid to the first 8 weeks of therapy. Primary Objectives: Describe the relationship between the length of the experimental treatment regimen and the percentage of participants with sustained cure at 76 weeks after randomization without treatment failure or relapse. Describe the connection between baseline prognostic risk strata and sustained cure at 76 weeks after randomization without treatment success or relapse at randomization. At 76 weeks after randomization without treatment failure or relapse, Evaluate the relationship between novel biologic markers and sustained cure. Secondary Objectives: Determine the shortest duration of the research protocol that has acceptable safety and efficacy for a Phase 3 clinical trial of the DRAMATIC regimen for MDR-TB therapy. When stratified by severity of disease, determine how time to sputum culture conversion predicts the longest duration of therapy. Describe the relationship between the length of the experimental regimen and the percentage of participants with sustained cure at 104 weeks after randomization without failed treatment or relapse at randomization. The introduction of a shorter, more tolerated treatment regimen will greatly improve the ability of TB control clinics to treat the increasing number of patients.

Source link: https://clinicaltrials.gov/ct2/show/NCT03828201


Prospective, Randomized, Blinded Phase II Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination With Optimized Background Regimen for the Treatment of MDR-TB

"Fluoroquinolones are an integral component of MDR-TB treatment; consistently improved results have been seen in patients with MDR-TB treated with FQ; and newer FQ are the most effective antituberculosis agents available for MDR-TB therapy. " Levofloxacin is currently prescribed for TB in doses of 11-14 mg/kg/day, and has been well tolerated at doses up to 20 mg/kg. Although the effectiveness of levofloxacin in animal studies of TB and human studies of gram-negative bacteria hasn't been established in human studies, its use in human TB studies has not been investigated. We will determine the levofloxacin dose and exposure that result in the biggest decrease in mycobacterial burden while still providing acceptable tolerability by investigating 120 adults with smear- and culture-positive pulmonary MDR-TB at Peru and South Africa in this Phase 2 study. Specific Aims: Specific Aims: Specific Aims: Specific Aims: Specific Aims: Determine the levofloxacin AUC/MIC that converts in solid medium in the shortest time. Aim 2: To determine the highest levofloxacin AUC that is both safe and associated with less than 25% of patients discontinuing or reducing their dose of levofloxacin. Especially in areas with limited funding, where MDR-TB prevalence is the highest," says the designer.

Source link: https://clinicaltrials.gov/ct2/show/NCT01918397

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions