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Tuberculosis clinical trials

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NCT ID: NCT02256696 Completed - Clinical trials for Pulmonary Tuberculosis

Assessing PA-824 for Tuberculosis (the APT Trial)

Start date: April 29, 2015
Phase: Phase 2
Study type: Interventional

Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA Office of Orphan Products Development (OOPD)

NCT ID: NCT02253537 Completed - Tuberculosis Clinical Trials

Evaluation of the QuantiFERON-TB Test.

Start date: February 2, 2015
Phase:
Study type: Observational

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

NCT ID: NCT02252198 Completed - Tuberculosis Clinical Trials

Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests

FIND
Start date: February 2014
Phase: N/A
Study type: Observational

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenatâ„¢ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

NCT ID: NCT02251327 Completed - Tuberculosis Clinical Trials

Feasibility and Accuracy of a Novel Xpert Cartridge

(XpertDST)
Start date: June 4, 2014
Phase:
Study type: Observational

Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.

NCT ID: NCT02238405 Completed - Smoking Cessation Clinical Trials

A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes

Start date: May 25, 2015
Phase: N/A
Study type: Interventional

The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.

NCT ID: NCT02237365 Completed - Clinical trials for Tuberculous Meningitis

A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis

AspirinTBM
Start date: October 17, 2014
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis is a severe brain infection which often causes disability and death even when treated with the best available treatment. Aspirin is a type of anti-inflammation drug which can reduce the inflammatory response in brains of patients with tuberculous meningitis, and therefore may decrease some of the most severe outcomes. This study compares the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the standard treatment to see if aspirin is safe and helpful in reducing disability and death from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days and followed up while on standard treatment for 8 months.

NCT ID: NCT02236078 Completed - Tuberculosis Clinical Trials

Brief Bactericidal Activity of Anti-Tuberculosis Drugs

BBA
Start date: November 2015
Phase: Phase 1
Study type: Interventional

The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4 mcg/ml but resistant at 0.1 mcg/ml when tested in the BD MGIT 960 system. Further, the investigators will investigate the molecular genetic determinants of these differences in susceptibility. To achieve these objectives the investigators will carry out an innovative variation on early bactericidal activity (EBA) study methodology. Patients at risk for drug-resistant TB will be screened for INH resistance using approved molecular assays. In those with INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will be available within 7 days. If the DST results show the susceptibility patterns noted above, patients will receive 900 mg/d INH (600 mg if <45kg), and assess its effect with serial quantitative sputum cultures for 6 days. If the concentration of viable bacteria decreases significantly, the investigators will interpret this to mean the drug is having an effect. If not, the drug is ineffective. After 6 days, the patients will resume treatment according to national guidelines. In case the investigators identify drugs that are effective under these conditions, the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterial isolates from these patients.

NCT ID: NCT02234908 Completed - Tuberculosis Clinical Trials

Rewards for Tuberculosis Contact Screening

RECON
Start date: October 2014
Phase: N/A
Study type: Interventional

This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize.The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.

NCT ID: NCT02231229 Completed - Tuberculosis Clinical Trials

Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation

FAST-TB
Start date: July 23, 2014
Phase: Phase 4
Study type: Interventional

French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings. the duration of treatment is 6 months or 12 months.

NCT ID: NCT02219945 Completed - Clinical trials for Pulmonary Tuberculosis Suspected

ENOSE in Pulmonary Tuberculosis in Yogyakarta

YOGYATBNOSE
Start date: November 2013
Phase: N/A
Study type: Interventional

Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.