View clinical trials related to Tuberculosis.
Filter by:Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.
This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis
Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective - To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives - To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). - To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions - To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure - To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. - To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients - To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatment regimen. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All doses of study drugs will be given under direct observation and administered 5 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. The study extension will be a prospective, multicenter clinical trial. Eligibility criteria will be the same as for the main study. Participants will be randomized to one of four regimens: the standard intensive phase treatment regimen, an investigational regimen in which rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs will be administered 7 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine concentration at or after the week 2 visit during intensive phase therapy. This study is being conducted in 2 phases. 1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually enrolled. 2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data collection and endpoints otherwise similar to the main study. The projected sample size for the study extension is 320 enrollments.
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: - 100 mg OPC-67683 twice daily (BID) - 200 mg OPC-67683 BID - Placebo BID After 56 days participants will complete their optimized background regimen (OBR).
The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10^7, 5 x 10^7 or 1 x 10^8 pfu. Participants will be identified from the general population living in Worcester, Western Cape, South Africa
The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can improve response to standard short course TB therapy in people with newly diagnosed pulmonary TB.
The primary goal of this study is to assess the effectiveness of two alcohol interventions administered singly or in combination as an integrated component of TB care provided to patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this study: First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the following four study arms: 1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist); 2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU 3. BCI + Naltrexone/BBCET plus TAU 4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the pilot study. However, because the pilot does not have a control group and nor is it a Phase I clinical trial, we define "safety" here as demonstration of appropriate adverse event management and adequate safety monitoring procedures, all of which will also be used in the RCT. The specific aims of the pilot are: 1. To determine the feasibility of administering Naltrexone to patients receiving TB treatment, and 2. To assess the safety of administering Naltrexone to patients receiving TB treatment. The investigators aim to test the following hypotheses for the pilot: co-administration of Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs. The specific aims of the RCT are: 1. To compare TB treatment outcomes among patients in each of the three intervention arms with the control arm of treatment as usual, and 2. To compare the change in mean number of heavy drinking days in last month of study period compared with baseline among patients in each of the three intervention arms with the control arm of treatment as usual. The investigators aim to test the following hypotheses for the RCT: Individuals receiving one of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will experience better TB outcomes and a greater change in the mean number of heavy drinking days, compared with individuals receiving treatment as usual.
The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)