Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
NCT ID: NCT00760149
Last Updated: 2013-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2010-07-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
50 patients, treated with the standard anti-TB regimen, including rifampicin (600 mg), isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 2 placebo tablets resembling rifampicin 300 mg.
Rifampicin in higher doses
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
2
50 patients, treated with rifampicin (900 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 1 placebo tablet resembling rifampicin 300 mg.
Rifampicin in higher doses
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
3
50 patients, treated with rifampicin (1200 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment.
Rifampicin in higher doses
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
Interventions
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Rifampicin in higher doses
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
Eligibility Criteria
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Inclusion Criteria
* Participant is willing to be tested for HIV.
* Participant is at least 18, but not more than 65 years of age at the day of the first dosing of study medication.
* Participant is admitted to KNTH or KCMC during the intensive phase of TB treatment.
* Participant is able and willing to attend to KNTH or KCMC regularly during the continuation phase of TB treatment.
* Participant is able to understand and willing to sign the Informed Consent Form prior to screening evaluations.
* Female participants should understand that it is important not to get pregnant during the study. They should agree on taking measures to prevent them from getting pregnant during the study. They should agree on taking measures to prevent them from getting pregnant, such as using a contraceptive device or barrier method.
Exclusion Criteria
* Participant's body weight is less than 50 kg.
* Participant has abnormal liver function test or serum creatinine (defined as levels higher than the upper limit of normal).
* Participant has a relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, Diabetes Mellitus, renal or hepatic disease, use of concomitant drugs that interfere with the pharmacokinetics of anti-TB drugs).
* Participant is on anti-retroviral treatment at inclusion.
* Participant has a CD4 count less than 350 cells/mm3.
* Participant has a Karnofsky score of less than 40.
* Participant is pregnant or breastfeeding.
* Participant has a Multi Drug Resistant (MDR)-TB for which another than the standard treatment regimen is needed.
18 Years
65 Years
ALL
No
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Sanofi
INDUSTRY
Kilimanjaro Christian Medical Centre, Tanzania
OTHER
Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania
UNKNOWN
University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands
UNKNOWN
National Institute for Public Health and the Environment (RIVM)
OTHER_GOV
Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre, the Netherlands
Principal Investigators
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Rob Aarnoutse, Pharm-D, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Gibson Kibiki, MD, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
Kilimanjaro Christian Medical Centre,Moshi,Tanzania
Martin Boeree, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center/UCCZ Dekkerswald
Locations
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Kibong'oto National Tuberculosis Hospital
Sanya Juu, Kilimanjaro, Tanzania
Countries
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References
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Other Identifiers
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PACTR2009060001493909
Identifier Type: REGISTRY
Identifier Source: secondary_id
APRIORI 4.1
Identifier Type: -
Identifier Source: org_study_id