MedPath

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

Not Applicable
Completed
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

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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