Status:
COMPLETED
Tuberculosis Treatment Shortening Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 sam...
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 p...
Eligibility Criteria
Inclusion
- Adults, male or female, aged 18-60. -Newly diagnosed initial episodes of pulmonary tuberculosis. Sputum smear-positive and -negative patients are eligible for enrollment. The diagnosis of tuberculosis must be confirmed by culture. Acid fast bacteria (AFB) smear positive patients found later not to have tuberculosis (TB) (i.e. those with non-tuberculous mycobacterial disease) and those without culture confirmation \[at least one culture on solid media growing \> 10 colonies of Mycobacterium tuberculosis (MTB) or a positive BACTEC or Mycobacteria growth indicator tube (MGIT) enriched liquid culture growing MTB\] will be removed from the study. -Chest X-ray and clinical findings consistent with tuberculosis. -Hemoglobin greater than or equal to 8 gm/dL (greater than or equal to 5.0 mmol/L). -Serum creatinine \< 2 mg/dL (\< 177 micro mol/L). -Serum aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal for the testing laboratory, and serum total bilirubin \< 1.3 mg/dL (22.2 micro mol/L). -Random serum glucose less than or equal to 150 mg/dl (8.3 mmol/L). -Ambulatory. -Willing to provide informed consent for study participation, provide required specimens for examination, and to undergo and receive results of human immunodeficiency virus (HIV) testing. -Willing to receive supervised anti-TB treatment. -Completion of the required 112 doses of chemotherapy within 18 weeks of starting treatment.
Exclusion
- Human immunodeficiency virus (HIV)-infected. -History of prior tuberculosis or history of previous tuberculosis treatment. -Pregnant or breastfeeding. -Cavitary tuberculosis on initial chest X-ray (taken within 14 days of study entry). -Exposure to person(s) with known drug resistant tuberculosis. -Patients receiving chronic steroids or other immunosuppressive medications. -Extra-pulmonary tuberculosis. -Patients with drug resistant tuberculosis (resistance to isoniazid (INH), rifampicin, pyrazinamide or ethambutol). -Professional sex worker, alcoholic and/or intravenous (IV) drug abuser. -Silicosis or other serious chronic medical problems including diabetes mellitus or chronic renal failure. Final determination of eligibility will be made after review of drug susceptibility testing results on an initial sputum isolate and results of all sputum cultures. Pregnant patients may not be enrolled in the study. Patients in the 4 month arm who become pregnant during months 5 and 6 of study participation will be dropped from the study and receive an additional 2 months of treatment with INH and rifampicin.
Key Trial Info
Start Date :
April 8 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2008
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00130247
Start Date
April 8 2002
End Date
November 28 2008
Last Update
November 8 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidade Federal do Espirito Santo - Duke Hubert-Yeargan Center
Vitória, Espírito Santo, Brazil, 29040-091
2
Makati Medical Center
Makati City, National Capital Region, Philippines, 1229
3
Mulago Hospital Complex
Kampala, Uganda, 99999