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Tuberculosis clinical trials

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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.

NCT ID: NCT00164281 Completed - HIV Infections Clinical Trials

Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

NCT ID: NCT00157066 Completed - Tuberculosis Clinical Trials

Effects of Vitamin D Supplementation on Antimycobacterial Immunity

Start date: December 2002
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.

NCT ID: NCT00149448 Completed - Tuberculosis Clinical Trials

Effectiveness of the TB Contact Priority Model

Start date: May 2004
Phase: N/A
Study type: Observational

The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.

NCT ID: NCT00146744 Completed - Tuberculosis (TB) Clinical Trials

Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults

Start date: July 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.

NCT ID: NCT00146302 Completed - Tuberculosis Clinical Trials

Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?

Start date: November 2002
Phase: Phase 4
Study type: Interventional

The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks. Due to difficulties in establishing the correct gestational age, the vaccination policy for BCG in many developing countries is defined by birth weight rather than by gestational maturity. In the study area, low birth weight (LBW) infants (< 2500 g) are not supposed to be vaccinated at birth; instead the mother is asked to return for vaccination when the child has gained sufficient weight. BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of early vaccination of LBW children for adverse events, purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity, and mortality in a randomised prospective study of BCG vaccination at birth versus later (according to policy) among children 19 months of age in Guinea-Bissau. The hypothesis is that BCG vaccination of low birth weight (LBW) children at birth reduces infant mortality of this high-risk group by 25%.