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Tuberculosis clinical trials

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NCT ID: NCT01424670 Completed - Clinical trials for Multidrug-resistant Tuberculosis

Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

Start date: September 2, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.

NCT ID: NCT01424501 Terminated - Tuberculosis Clinical Trials

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease

Start date: November 14, 2011
Phase: Phase 2
Study type: Interventional

This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB disease (denoted TB-naïve cohort) will also be enrolled.

NCT ID: NCT01422798 Completed - Tuberculosis Clinical Trials

An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda

Start date: April 2012
Phase: N/A
Study type: Observational

The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.

NCT ID: NCT01417988 Terminated - Tuberculosis Clinical Trials

Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment

PrOMPT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

This study investigates the prevention of early mortality in patients initiating antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB reside. Many published studies have shown a surprisingly high proportion of all patients initiated on ART dying within 6 months (8-26%) with increasing risk with decreasing CD4 T cell count. The majority (median 70%) occur in the first 3 months with the greatest proportion of deaths due to previously undiagnosed tuberculosis (TB). The investigators will enroll patients from 4 geographically diverse countries (Gabon, Mozambique, South Africa, and Uganda) in a randomized open label clinical trial targeting a population of people with high mortality risk; patients with CD4 T cell count < 50 cells/μl and body mass index (BMI) < 18 kg/m2. Severely immunocompromised patients with low BMI in the intervention arm will receive presumptive anti-TB 4-drug chemotherapy and subsequently initiate ART within 2 weeks compared to ART alone. The main objective is to measure and compare early mortality in the group presumptively treated for TB in addition to ART. Other sub-objectives are to determine the predictors of early mortality and the causes of death by autopsy (traditional and verbal), to determine if presumptive anti-TB treatment affects viral suppression with ART, and to assess incidence rates and characterize drug toxicity in patients dually treated. Because of the high rates of TB co-infection in sub-Saharan Africa in the HIV-infected, the investigators expect that patients presumptively treated for TB in addition to HIV will have a lower mortality rate than patients receiving ART only. This trial is expected to be of great public health benefit and generalisability.

NCT ID: NCT01408914 Completed - Tuberculosis Clinical Trials

Trial of High-Dose Rifampin in Patients With TB

HIRIF
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood concentrations will result in tuberculosis bugs being killed more quickly; and, both of these will happen without more adverse events. Patients with active, infectious, drug-susceptible TB who agree to participate will be randomly assigned to 1 of 3 doses of RIF. All patients will also receive standard doses of regular (3) companion drugs for 2 months of daily, supervised therapy. The study will assess the following among the 3 study arms (oral doses of RIF 10, 15 & 20 mg/kg/day) during the initial 8 weeks of treatment: 1) the amount of RIF in the blood after at least 14 days of treatment; 2) the difference in the number of tuberculosis bugs killed; 3) the frequency of adverse events.

NCT ID: NCT01404312 Completed - HIV Infections Clinical Trials

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Start date: May 23, 2012
Phase: Phase 3
Study type: Interventional

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

NCT ID: NCT01398618 Active, not recruiting - Clinical trials for Latent Tuberculosis Infection

Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)

Start date: May 2011
Phase: Phase 3
Study type: Interventional

Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in recent years. Further reduction in TB incidence, or even elimination should rely on treatment for LTBI. However, which is the cost-effective screening method or what is the cost-effective regimen in Taiwan is still unclear. Therefore, the investigators designed this prospective study to follow up adult household contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month rifampicin).

NCT ID: NCT01395654 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Start date: July 2011
Phase: Phase 4
Study type: Interventional

Despite the availability of effective anti-tuberculosis agents that exist to treat this illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use. There is no consensus on method of the reintroduction of anti-TB medications. The risk of reintroducing of a anti-TB medications could be hazardous. There are several differences between the guidelines from the ATS, BTS and the Task Force of the European Respiratory Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the methods of reintroducing of anti-TB medications. The investigators plan to do a prospective study to evaluate the outcome and safety of reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment among TB patients in the investigators hospital.

NCT ID: NCT01392911 Completed - Clinical trials for Pulmonary Tuberculosis (TB)

Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB

HR1
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This is the first trial in a series of clinical trials that aim to bring the concept of high dose rifampicin beyond phase II of clinical development. The safety, tolerability, extended early bactericidal activity (EBA) and pharmacokinetics of several doses of Rifampicin with or without standard doses of Isoniazid, Pyrazinamide and Ethambutol in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB will be assessed. The objective of this study is to find the maximum tolerable dose of Rifampicin as monotherapy and in combination with the currently available Isoniazid, Pyrazinamide and Ethambutol. The subjects will be in the study for 24-31 days. After a screening period of 9-3 days, the subjects will receive treatment with Rifampicin as single drug during 7 days (monotherapy). This treatment will be followed by treatment with 7 days of Rifampicin and Isoniazid, Pyrazinamide and Ethambutol (combination therapy), and 7-8 days treatment with standard TB medication. All subjects will be closely monitored for side effects. This monitoring will include daily interviews and physical examination, and ECG evaluation and blood and urine analyses at specific intervals. During the 7 days of monotherapy, after the second day of the combination therapy and at the end of the combination therapy, overnight sputum will be collected from the patients to investigate the potency of high dose rifampicin to reduce this number of bacilli. The Rifampicin dose will be increased step by step and group by group. The control group will receive the standard dose of 10 mg Rifampicin/kg, whereas the first treatment group will receive 20 mg/kg. The Rifampicin dose will only be further increased for a next group of patients, if this is expected to be safe. Rifampicin is widely available and not expensive. Physicians all over the world have experience with this drug and its adverse effects. Should this study be successful, the highest dose of Rifampicin that this safe and tolerable will be given to a larger group of patients. in the next study. If increasing the dose of Rifampicin proves to be safe and effective, a higher dose of Rifampicin could be implemented broadly and quickly, and it would benefit many patients worldwide.

NCT ID: NCT01392365 Completed - Crohn's Disease Clinical Trials

Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Start date: July 2011
Phase: N/A
Study type: Observational

The aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease.