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Tuberculosis clinical trials

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NCT ID: NCT02771249 Completed - Clinical trials for HIV Infected Population With Latent Tuberculosis

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Start date: June 3, 2016
Phase: Phase 1
Study type: Interventional

People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekly treatment for latent TB would be easier for people with HIV to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid. However, they need to see how TB drugs and HIV drugs interact. Objective: To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely. Eligibility: Healthy adults ages 18 65. Design: Participants will be screened with a medical history and physical exam. They will have vital signs taken and give a blood sample. Women will have a pregnancy test. Participants cannot take any other medicines during the study, including vitamins. Only occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl , Zyrtec , Claritin , etc.) will be allowed. Participants will be assigned to one of three groups. Each group will take a different study drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a supply of the study drug tablets and instructions for taking them. Participants will keep a medicine diary to serve as a memory aid for taking medicine and reporting any side effects that they may experience. Participants will have 8 or 9 study visits over about 40 days. The number of visits depends on which group the person is assigned to. All visits will take place at the NIH Clinical Center. Participants will fast before study visits. The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last for about 12 hours. The other 4-5 visits will last about 1 hour. During all study visits, screening procedures will be repeated. During long visits, an intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to take blood.

NCT ID: NCT02768909 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB

Start date: January 2015
Phase: N/A
Study type: Interventional

Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.

NCT ID: NCT02765087 Recruiting - Clinical trials for Tuberculosis, Pleural

E-Nose: Diagnostic Tool for Pleural TB

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the current gold standard.

NCT ID: NCT02759848 Completed - Clinical trials for The Role of Tuberculosis in COPD

The Role of Tuberculosis in Chronic Obstructive Lung Disease

TROTIC
Start date: January 2012
Phase: N/A
Study type: Observational

Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.

NCT ID: NCT02758236 Completed - MDR TB Clinical Trials

Tuberculosis Research of INA-RESPOND On Drug Resistance

TRIPOD
Start date: February 13, 2017
Phase:
Study type: Observational

This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study.

NCT ID: NCT02754765 Completed - Clinical trials for Infection, Bacterial

Evaluating Newly Approved Drugs for Multidrug-resistant TB

endTB
Start date: December 2016
Phase: Phase 3
Study type: Interventional

endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).

NCT ID: NCT02744521 Not yet recruiting - Tuberculosis Clinical Trials

Training Inmate Peer Educators in Detecting Tuberculosis in a Developing Country Prison: A Cluster Randomized Trial

Start date: March 2016
Phase: N/A
Study type: Interventional

Introduction: Finding and successfully treating all tuberculosis (TB) patients is the cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there is a need to find feasible interventions to find and treat TB patients in these settings. Objective: The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings. Methodology: This is a matched cluster randomized control trial where randomization to the intervention and treatment groups will be carried out within pairs. Eight matched prison pairs will be randomly selected for this study in which eight prisons from each pair will be randomly assigned to the intervention and the remaining to the control group. Trained prison peer educators at the intervention sites will organize and provide education about TB every two weeks on a regular basis for one year. Peer educators will also perform routine TB screening, using a screening protocol to identify presumptive TB cases for a referral. Identified presumptive TB cases will then be linked to the prison health personnel for a referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case finding in the control sites will follow the existing referral system (self-referral to nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or chest X-ray as in the intervention sites. The data will be entered using Epi Data entry version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage of patients symptomatic for > =3 months will be compared within pairs using the paired t-test or sign test as appropriate.

NCT ID: NCT02744469 Completed - Tuberculosis Clinical Trials

Benin Population Diversity of Tuberculosis and Implications

BeniDiT
Start date: April 12, 2016
Phase:
Study type: Observational

Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. This study will also find out whether the type that affects a patient, depends on patient characteristics and whether the difference affects the outcome of the treatment. Finally the study will also help to find out whether diagnostic tests are reliable for all types of the microbe. This information will be used after the study to inform decision making in order to improve tuberculosis control.

NCT ID: NCT02736864 Completed - Clinical trials for Pulmonary Tuberculosis

Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Start date: September 28, 2016
Phase: N/A
Study type: Observational

The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

NCT ID: NCT02735590 Active, not recruiting - Tuberculosis Clinical Trials

The Correlate of Risk Targeted Intervention Study

CORTIS
Start date: September 20, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Effective tuberculosis (TB) control requires that people who progress from latent Mycobacterium tuberculosis (MTB) infection (LTBI) to TB disease are identified and treated before they infect others. A prognostic correlate of risk (COR), based on messenger ribonucleic acid (mRNA) expression signatures, which prospectively discriminates between TB cases and healthy controls, has been constructed and validated. Based on published microarray case-control datasets, the COR has 87% diagnostic sensitivity and 97% specificity for prevalent TB disease; and in two nested case-control studies, 70% prognostic sensitivity and 84% specificity for incident TB disease occurring within one year of sampling (HIV uninfected persons). Diagnostic and prognostic performance of the COR has not yet been tested in a prospective cohort. COR+ status is not directly associated with LTBI; and may, or may not, be amenable to preventive therapy. Although effective in the short-term, preventive therapy is not recommended for treatment of LTBI in HIV uninfected adults living in high TB burden countries, due to rapid loss of protection; and treatment burden. A 3-month, 12-dose, once-weekly preventive therapy regimen of high dose Isoniazid (INH) and Rifapentine (3HP) has been recommended as equivalent to 6 months of daily INH for treatment of LTBI in low TB burden countries by the World Health Organization (WHO). A 'screen & treat' strategy, based on serial mass campaigns to provide targeted, short-course preventive therapy only to COR+ persons at highest risk of TB disease, may offer the solution for durable, community-wide protection in high TB burden countries. The efficacy of 3HP for prevention of incident TB disease in COR+ persons has not yet been tested in a clinical trial. Primary Aims 1. Test whether preventive therapy (3HP) reduces the rate of incident TB disease, compared to standard of care (active surveillance), in COR+ persons. 2. Test whether COR status differentiates persons with cumulative prevalent or incident TB disease from persons without TB disease. Secondary Aims 1. Estimate whether COR status differentiates persons at high risk for incident TB disease from persons at low risk for incident TB disease 2. Compare prognostic performance of the COR for incident TB disease with Interferon-gamma release assay (IGRA).