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Tuberculosis clinical trials

View clinical trials related to Tuberculosis.

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NCT ID: NCT05455112 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

CONSTAN-ARG
Start date: October 29, 2022
Phase: Phase 2
Study type: Interventional

This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but also against bacteria in a latent state that are less sensitive to antibiotic treatments. Therapeutic vaccination in patients with pulmonary tuberculosis could improve the speed of recovery of patients without inducing the appearance of drug resistance.

NCT ID: NCT05454345 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

Start date: October 1, 2022
Phase: Phase 3
Study type: Interventional

This study is a clinical trial conducted to determine whether the sitafloxacin-containing three-month regimens are as effective as the standard six-month regimen and the four-month rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and moxifloxacin for ethambutol) for treatment of pulmonary tuberculosis. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide, followed by four months of isoniazid and rifampin. The four-month regimen consists of two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid rifapentine and moxifloxacin. The new three-month tuberculosis treatment regimens are six weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide, followed by seven weeks of isoniazid, rifapentine, and Sitafloxacin, or 13 weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide. The primary research question is to evaluate the efficacy and safety of the 3 month Sitafloxacin-containing regimen, and to determine if it can shorten the treatment of drug-susceptible pulmonary tuberculosis while achieving non-inferiority in treatment success with the current 6 month and 4 month treatment regimens. Safety, side effects of Sitafloxacin for participants in the clinical trial are also assessed. Rates of cure, treatment success, recurrence, and cure (cure without recurrence) are determined for subgroup analysis in the standard six-month regimen group, the four-month regimen group, and two three-month regimen groups.

NCT ID: NCT05452616 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

SaDAPT
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.

NCT ID: NCT05443178 Recruiting - Clinical trials for Tuberculosis Infection

Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

In vitro and in vivo data show promising results of adjunctive use of Chloroquine to standard tuberculosis therapy as Chloroquine enhances animicrobial effectiveness against intracellular MTB. To date, no safety data of the concurrent use of both treatments is availble. In a phase I trial, the investigators aim to evaluate safety and tolerability of the concurrent use of Chloroquine and standard anti-TB drug in healthy volunteers.

NCT ID: NCT05428124 Completed - Fertility Disorders Clinical Trials

Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report

Start date: January 1, 2014
Phase:
Study type: Observational

This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients.

NCT ID: NCT05426720 Recruiting - Pulmonary TB Clinical Trials

Risk Factors and Biomarkers for Post-tuberculosis Lung Damage

Start date: January 1, 2022
Phase:
Study type: Observational

This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.

NCT ID: NCT05423847 Recruiting - Tuberculosis Clinical Trials

Triage UltraSound in Tb Endemic Regions

TrUST
Start date: October 14, 2021
Phase:
Study type: Observational

In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice.

NCT ID: NCT05413551 Recruiting - Clinical trials for Tuberculosis Infection

Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

Start date: March 23, 2023
Phase: Phase 1
Study type: Interventional

This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.

NCT ID: NCT05412212 Active, not recruiting - Latent Tuberculosis Clinical Trials

Brief Educational Video for Patients Prescribed LTBI Treatment

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. The investigators hypothesize that a 3-minute educational LTBI video intervention will improve treatment completion compared to standard care (no intervention). A randomized trial will be conducted at Kaiser Permanente Southern California, including adults who are prescribed treatment for LTBI, identified using an electronic health record algorithm. At the time of treatment prescription, patients will be randomized to receive the LTBI video intervention or standard care at a ratio of 2 to 1. Those in the intervention group will be sent a secure text message or e-mail with a link to the video. Individuals who watch the LTBI video will be invited to respond to 4 short questions about their perceptions of the video accessibility and content. The primary outcome is LTBI treatment completion (dispensation of the required number of doses) in the year following prescription order. Secondary outcomes are LTBI treatment initiation (at least one dispensation) in the year following prescription order; initiation and completion within the year following prescription order stratified by LTBI treatment regimen (if feasible); the proportion of individuals randomized to the intervention group who watched the LTBI video; and the perceptions of those who watched the video. The primary analysis will be based on intention-to-treat. Characteristics of individuals in the intervention and standard care groups will be described, and rates of LTBI treatment completion will be calculated. To assess the effect of the intervention, Poisson regression with robust standard errors will be used to estimate unadjusted and adjusted rate ratios and 95% confidence intervals. Per-protocol analyses will also be conducted, comparing those in the intervention group who watched the LTBI video to those in the standard care group. Similar methods will be used for secondary analyses. Assuming the completion rate in the standard care group is 0.5 (based on recent KPSC data), approximately 918 patients will be needed to achieve 80% power with type one error 0.05 to detect an intervention effect of 0.10 in the completion rate between groups. This sample size will be feasible to achieve over the 1 year trial duration.

NCT ID: NCT05411744 Recruiting - Clinical trials for End Stage Renal Disease

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective, single-center, single-arm, open-label study investigating the safety, compliance and pharmacokinetics of 1-month treatment of Isoniazid, Rifapentine and Vitamin B6 in renal transplant candidates.