An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis

Not Applicable

• Conditions: Tuberculosis

• Registration Number: PACTR2008060000861040
• Lead Sponsor: St Georges Hospital Medical School trading as St Georges University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Newly diagnosed pulmonary tuberculosis
2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy
3. Either no previous anti-tuberculosis chemotherapy, or less than two weeks of previous chemotherapy
4. Aged 18 years and over
5. A firm home address that is readily accessible for visiting and be intending to remain there during the entire treatment and follow up period
6. Willing to agree to participate in the study and to give a sample of blood for HIV testing

Exclusion Criteria

1. Has any condition (except HIV infection) that may prove fatal during the study period
2. Has Tuberculous (TB) meningitis
3. Has pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g., insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis
4. Is female and known to be pregnant, or breast feeding
5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Rifamycin Monoresistance (RMR) in relapse cultures of HIV infected patients;Occurrence of serious adverse events at any time during chemotherapy, recorded as they present themselves ;Combined rate of failure at the end of treatment and relapse,

Secondary Outcome Measures

Name	Time	Method
Sputum culture results at two months after the initiation of chemotherapy, ;Rate of completion of chemotherapy according to the protocol;Number of observed doses of chemotherapy ingested;Any adverse events