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Tuberculosis clinical trials

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NCT ID: NCT01181856 Completed - Tuberculosis Clinical Trials

Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route

Start date: January 2010
Phase: Phase 1
Study type: Interventional

This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).

NCT ID: NCT01167647 Completed - Tuberculosis Clinical Trials

The Role of Routine Bacterial Culture Including Tuberculosis During Bronchoscopy: A Prospective Study

Start date: July 2010
Phase: N/A
Study type: Observational

Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined.

NCT ID: NCT01167452 Completed - Obesity Clinical Trials

Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data analysis. All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.

NCT ID: NCT01165840 Completed - Obesity Clinical Trials

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.

NCT ID: NCT01162486 Completed - Tuberculosis Clinical Trials

Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers

TBTC S29B
Start date: April 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.

NCT ID: NCT01162265 Completed - Tuberculosis Clinical Trials

Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection

PREDICT
Start date: August 2010
Phase:
Study type: Observational

The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at increased risk of TB. Those at increased risk are defined as either newly arrived immigrants or people who have been in contact with TB cases. The study will also provide information on the cost effectiveness of different testing strategies, such as the two step testing approach recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment programme. 10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in London. All participants will have the skin test and blood taken for both assays. Disease status of participants will then be followed up for an average of 24 months using the national register of clinical reports, a phone call and the national microbiological database. The risk of developing active disease is highest in the first two years after exposure. During followup there will be no additional diagnostic procedures unless symptoms occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random 25% of participants, will have a repeat IGRA test shortly after the first test to investigate whether the skin test affects the result of the blood test.

NCT ID: NCT01158755 Completed - Pharmacokinetics Clinical Trials

Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years. There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.

NCT ID: NCT01156623 Completed - Clinical trials for Non-small Cell Lung Cancer

Endobronchial Ultrasound Guided Transbronchial Aspiration (EBUS-TBNA) in Non Small Cell Lung Cancer (NSCLC) in a Tuberculosis-endemic Country

Start date: June 2010
Phase: N/A
Study type: Interventional

In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) scan frequently show discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal diagnosis. The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced CT and PET scan with and without EBUS-TBNA, this study will be performed.

NCT ID: NCT01154959 Completed - Clinical trials for Pulmonary Tuberculosis

Latency in Pulmonary Tuberculosis

Start date: February 2010
Phase: Phase 3
Study type: Interventional

The immune responses in latent tuberculosis are poorly understood. While it is difficult to define the onset of latency during natural infection, patients undergoing treatment for tuberculosis are driven into a state of latency or cure. The present study on the effect of 3 and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune responses pre and post treatment. We will evaluate a variety of innate and adaptive immune responses in patients before and after treatment and our study will compare the differences in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens) at different time points following treatment. In addition, since a small percentage of patients will undergo relapse following treatment, the kinetics of immune responses in these patients will used to assess immunological predictors of relapse in tuberculosis.

NCT ID: NCT01151189 Completed - HIV Infections Clinical Trials

Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)

Start date: July 2011
Phase: Phase 2
Study type: Interventional

This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults. This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).