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Tuberculosis clinical trials

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NCT ID: NCT00192556 Completed - Tuberculosis Clinical Trials

Food Incentives for TB Treatment Compliance in East Timor (FITTCET)

Start date: March 2005
Phase: N/A
Study type: Interventional

This study will examine whether food is a cost-effective method for improving treatment compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally available, locally acceptable, cheap and highly nutritious food at the clinic will encourage patients to come for daily directly observed treatment, and thus improve the chance of TB cure and decrease the chance of the development of TB drug resistance. Primary outcome will be successful completion of treatment and secondary outcomes will include treatment compliance and clinical and biological measures of nutritional improvement.

NCT ID: NCT00174083 Recruiting - Tuberculosis Clinical Trials

Diagnosis of Active Tuberculosis by ELISPOT

Start date: August 2005
Phase: N/A
Study type: Observational

Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection. However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic tool for active tuberculosis in clinical suspects in Taiwan.

NCT ID: NCT00173433 Completed - Tuberculosis Clinical Trials

Exogenous Reinfection of Tuberculosis in Taiwan

Start date: August 2005
Phase: N/A
Study type: Observational

we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

NCT ID: NCT00173264 Recruiting - Tuberculosis Clinical Trials

Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

Start date: June 2005
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether the monoclonal protein in patients with tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes coding their monoclonal proteins show characteristic mutations.

NCT ID: NCT00172783 Recruiting - Tuberculosis Clinical Trials

PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period

Start date: June 2005
Phase: N/A
Study type: Observational

To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.

NCT ID: NCT00170638 Completed - Tuberculosis Clinical Trials

Tuberculosis Immunity in Children

Start date: April 2005
Phase: N/A
Study type: Observational

The purpose of this study is to gain a better understanding of how immunity to tuberculosis (TB) is maintained in children. When children get tuberculosis, it is more likely to spread to other parts of the body than when adults get it. This study will compare the blood cells that fight TB in children to the blood cells that fight TB in adults. Children enrolled in this study will have blood drawn on 1 or 2 occasions. Adult participants will be leukapheresed, a process in which blood passes through a machine collecting specific blood cells and returning the remaining blood to the body. An estimated 260 subjects will be enrolled in this study.

NCT ID: NCT00170404 Completed - Clinical trials for Mycobacterium Tuberculosis

TB Nutrition, Immunology and Epidemiology

Start date: June 2000
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see whether people who take vitamins along with the standard medicine for tuberculosis (TB) recover better and quicker than people who take only the standard medicine for TB. This study will enroll 600 men and women, who are age 18-65 years, have TB, and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB therapy. Half the participants will have active TB and also HIV infection, and the other half will have TB alone. Half the volunteers will be given vitamins, and the other half will be given placebo (sugar pill with no vitamins) from the start of their TB therapy, through the 8 months of anti-TB therapy, and up to 48 months. Participation in the study involves visits to the clinic, physical exams, home visits, and answering questions about personal health, foods eaten, household, occupation, and education. Volunteers will also provide blood, sputum, and urine samples.

NCT ID: NCT00170209 Completed - Clinical trials for Latent Tuberculosis Infection

Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)

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

Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to children, especially those living in the same household. Once children are exposed and infected they are at very high risk to develop active TB - which can be lethal if not detected and treated promptly. This makes it very important to detect TB infection as soon as possible, and treat this while it is still latent or dormant. Current therapy for latent TB infection is 9 months of Isoniazid; this is very effective if taken properly but because treatment is so long many children do not finish this. Four months of Rifampin is a recommended alternative. In adults this has been shown to be safer with much higher completion rates. However the effectiveness of this treatment is unclear, and is being studied in an ongoing study. The investigators plan to compare the safety as well as the acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard treatment) in children in several sites in Canada and other countries. It is hypothesized that among children at high risk for development of active TB, intolerance/adverse events will not be worse (non-inferiority), among those randomized to 4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of active TB will not be significantly higher (non-inferiority) in children taking 4RIF.

NCT ID: NCT00164463 Completed - Tuberculosis Clinical Trials

TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.

NCT ID: NCT00164450 Completed - Tuberculosis Clinical Trials

TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

Start date: September 2005
Phase: N/A
Study type: Interventional

Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.