Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130247
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2005-08-12
Brief Title:
Tuberculosis Treatment Shortening Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Study of Shortening the Duration of Standard Short Course Chemotherapy From 6 Months to 4 Months in HIV-non-infected Patients With Fully Drug-Susceptible Non-cavitary Pulmonary Tuberculosis With Negative Sputum Cultures After 2 Months of Anti-TB Treatment
Status:
COMPLETED
Status Verified Date:
2010-04-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tuberculosis TB is a serious infection that can affect the lungs and other parts of the body The usual way to treat TB is to take 4 medicines by mouth every day for 2 months then take 2 of the same medicines for 4 more months for a total of 6 months The purpose of this study is to see if taking 4 months of TB medicines is as effective in curing some TB patients as taking 6 months of TB medicines Study participants will include 758 human immunodeficiency virus HIV-non-infected individuals ages 18-60 Participants will be treated with 4 standard drugs called isoniazid rifampicin pyrazinamide and ethambutol All individuals will take TB medicines for at least 4 months After 4 months of treatment if no TB germs are growing in sputum samples participants will be assigned to either stop taking TB medicine 4 months of treatment or to continue taking TB drugs for 2 more months 6 months of treatment Participants will be involved in study procedures for up to 30 months
Detailed Description:
Tuberculosis TB is a major global health problem TB is the current leading cause of death due to an identifiable infectious agent worldwide One of the highest priorities for tuberculosis control programs is to shorten anti-TB treatment while maintaining its effectiveness Current 6-month short course chemotherapy regimens are over 95 effective for the treatment of tuberculosis when fully administered Six months is a long time however and patients frequently discontinue anti-TB treatment once their symptoms have improved The duration of standard short course chemotherapy is one of the major obstacles to its successful application and poses substantial challenges to programs with respect to patient adherence program resource needs and logistical requirements for directly observed therapy The primary objective of this study is to assess the efficacy of shortening anti-TB treatment to 4 months in human immunodeficiency virus HIV-non-infected adults with drug-susceptible non-cavitary pulmonary tuberculosis who convert their sputum culture to negative after 2 months of treatment Secondary objectives of this study include comparing pre-treatment sputum bacillary load in patients with and without cavitary disease compare time after inoculation of BACTEC or Mycobacteria growth indicator tube MGIT liquid culture media until positive with semi-quantitative sputum acid fast bacteria AFB smear and culture on solid media as measures of pre-treatment sputum bacillary load and determining the influence of immunologic characteristics of subjects pre-treatment during treatment and at the end of therapy on rate of bacillary clearance and risk for relapse A total of 758 HIV-non-infected adults male or female 18-60 years of age with newly diagnosed initial episodes of sputum AFB smear-positive or -negative culture-positive non-cavitary drug-susceptible pulmonary TB who are sputum culture negative after 2 months of anti-TB treatment will be randomly assigned to complete a total of 4 or 6 months of anti-TB therapy The experimental regimen will include a total of 4 months of anti-TB treatment 2 months of daily isoniazid INH rifampicin pyrazinamide and ethambutol followed by 2 months of daily INH and rifampicin The comparative regimen will include a total of 6 months standard short course anti-TB chemotherapy 2 months of daily INH rifampicin pyrazinamide and ethambutol followed by 4 months of daily INH and rifampicin Subjects will be involved in study related procedures for approximately 30 months after beginning the initial anti-TB treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None