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Tuberculosis clinical trials

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NCT ID: NCT02754765 Completed - Clinical trials for Infection, Bacterial

Evaluating Newly Approved Drugs for Multidrug-resistant TB

endTB
Start date: December 2016
Phase: Phase 3
Study type: Interventional

endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).

NCT ID: NCT02744469 Completed - Tuberculosis Clinical Trials

Benin Population Diversity of Tuberculosis and Implications

BeniDiT
Start date: April 12, 2016
Phase:
Study type: Observational

Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. This study will also find out whether the type that affects a patient, depends on patient characteristics and whether the difference affects the outcome of the treatment. Finally the study will also help to find out whether diagnostic tests are reliable for all types of the microbe. This information will be used after the study to inform decision making in order to improve tuberculosis control.

NCT ID: NCT02736864 Completed - Clinical trials for Pulmonary Tuberculosis

Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Start date: September 28, 2016
Phase: N/A
Study type: Observational

The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

NCT ID: NCT02729571 Completed - Tuberculosis Clinical Trials

Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults

MTBVAC-Ph1b
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL) (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28 after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three different dose levels ( (n=9 in each group).

NCT ID: NCT02729532 Completed - Tuberculosis Clinical Trials

Effect of Xpert MTB/RIF on Patient Outcomes

Start date: June 22, 2016
Phase:
Study type: Observational

A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.

NCT ID: NCT02727582 Completed - Clinical trials for Multidrug-resistant Tuberculosis

Pharmacometric Optimization of Second Line Drugs for MDR Tuberculosis Treatment

PODrtb
Start date: July 30, 2015
Phase:
Study type: Observational

Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid and rifampin, has been declared a global emergency. Treatment outcomes are poor, driven by toxicity and limited efficacy of the 2nd-line anti-TB drugs. Although there is evidence that both anti-TB activity and most of the toxicity of the key drugs are related to drug exposure, the pharmacokinetic/pharmacodynamic (PK/PD) relationships in patients with MDR-TB are poorly characterized. Moreover potential synergy of drug combinations has not been identified in the context of MDR-TB, dosing has not taken into account the concentrations needed to suppress resistance, and the role of minimum inhibitory concentrations (MICs) in dosing is poorly studied. There are therefore opportunities to optimize drug doses and combinations to improve efficacy, and reduce toxicity. Based on this observational study of patients on standard treatment for MDR-TB, our proposal builds on novel methodologies we have developed, largely for drug sensitive TB: 1. The application of computational analytical techniques to tease out the individual contributions of anti-TB drugs used in combination 2. The development of a treatment response biomarker model based on time-to-positivity in liquid culture of serial sputum samples. 3. The in vitro determination of PK targets for anti-TB activity and the suppression of resistance using the hollow fiber models of Mycobacterium tuberculosis (Mtb) (HFM-TB). Thus the research will enhance our understanding of current modalities of TB treatment, while contributing research approaches for future regimen optimization. This protocol describes the clinical research component (points 1&2). Aim 1: To characterize the effects of 2nd-line drug exposures on treatment response in MDR-TB patients. The 2nd-line drugs to be examined are those comprising the standardized regimen used in South Africa: kanamycin, pyrazinamide, moxifloxacin, ethionamide and terizidone. Hypothesis: Amongst patients on standard MDR-TB treatment, variation in drug exposure has a quantifiable impact on the rates at which viable Mtb are cleared from the sputum. Aim 2: To identify drug exposures associated with the risk of treatment-related toxicities in patients on a standard 2nd-line regimen for MDR-TB. Hypothesis: The risks of specific toxicities associated with kanamycin, pyrazinamide, moxifloxacin, ethionamide and terizidone are linked to drug concentrations.

NCT ID: NCT02712424 Completed - Tuberculosis Clinical Trials

DAR-901 TB Booster Vaccine to Prevent TB in Adolescents

DAR-PIA
Start date: March 2016
Phase: Phase 2
Study type: Interventional

DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection

NCT ID: NCT02709278 Completed - Tuberculosis Clinical Trials

Aerosol BCG Challenge Trial in Healthy UK Adults

Start date: March 7, 2016
Phase: Phase 1
Study type: Interventional

TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will also look to evaluate and compare the amount of BCG recovered from the lungs and from the skin, following challenge by either the aerosol or the intradermal route.

NCT ID: NCT02701439 Completed - Tuberculosis Clinical Trials

SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting

PTB
Start date: September 2012
Phase: N/A
Study type: Observational

This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.

NCT ID: NCT02700347 Completed - Tuberculosis Clinical Trials

Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Pyrazinamide Plus Allopurinol in Healthy Volunteers

Start date: February 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in healthy volunteers following administration of pyrazinamide alone and in combination with allopurinol.