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Tuberculosis clinical trials

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NCT ID: NCT01215851 Completed - Clinical trials for Pulmonary Tuberculosis

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z)

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

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

NCT ID: NCT01215110 Completed - Clinical trials for Pulmonary Tuberculosis

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

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

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of logCFU in sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

NCT ID: NCT01214993 Completed - Clinical trials for Infections, Human Immunodeficiency Virus and Tuberculosis

A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects

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

The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow. Absent such effects, one may conclude that the small increases in serum creatinine observed are due to the inhibition of the tubular secretion of creatinine via organic cation transporter 2 (OCT2) consistent with in vitro data. .

NCT ID: NCT01201941 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru

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

The objective of this study is to compare the effects of a web-based laboratory information system (e-Chasqui) between a network of health establishments with access to e-Chasqui (intervention group) and a network of health establishments without access to e-Chasqui (control group). The specific aims are: 1. To compare the "laboratory turn-around-time" (from the date a culture or drug susceptibility test (DST) result is obtained to the date the result is obtained at the health center) of samples pertaining to health establishments in the intervention versus the control group. 2. To compare the "clinical turn-around-time" (from the date the DST result is obtained to the date the patient is evaluated by a physician in possession of that result) among multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments in the intervention versus control group. 3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST results) between health establishments in the intervention versus control group. 4. To qualitatively assess the acceptability and usability of e-Chasqui among users in health establishments with access to the system. The investigators aim to test the following hypotheses: 1. The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access. 2. The clinical turn-around-time for patients pertaining to health establishments with e-Chasqui access will be smaller than that for patients in establishments without e-Chasqui access. 3. Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access. 4. Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.

NCT ID: NCT01198366 Completed - Tuberculosis Clinical Trials

Study of AERAS-402 in Healthy Infants

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.

NCT ID: NCT01194180 Completed - Tuberculosis Clinical Trials

A BCG Challenge Model Study to Assess Anti-mycobacterial Immunity Induced by BCG and a Candidate TB Vaccine, MVA85A

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

The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C or D, will be performed on a one-to-one alternating basis. Subjects in each group will be challenged by BCG administered intradermally. Prior to challenge, pre-existing immunity to TB will be induced by vaccination with BCG, MVA85A, and both in combination (when compared to BCG- & MVA85A-naïve individuals). BCG quantification will be assessed by analysing the tissue obtained in a punch biopsy of volunteers' skin over the site of BCG 'challenge' vaccination. Any reduction in BCG quantification between groups will then be correlated to existing (and future) laboratory assays of vaccine-induced immune responses in order to identify potential immunological correlates of protection.

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.