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Completed

NCT Number: NCT00760149

Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis

In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid, ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin plus the other drugs in standard dosages (third study arm). All patients will get the standard TB regimen during the continuation phase of treatment.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kibong'oto National Tuberculosis Hospital

Sanya Juu, Kilimanjaro, P.O. box 12, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has a newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two sputum specimens with ZN staining.
  • 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 has been treated with anti-tuberculosis drugs during the past three years.
  • 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.

Treatment and study plan

Rifampicin in higher doses

Drug

Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)

Primary outcomes

  1. Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol

    Time frame: Steady state, week 6

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: baseline, week 1, 2, 4, 6, 8, 10, 12

  2. Bacteriological response of Mycobacterium tuberculosis

    Time frame: Almost daily during first 8 weeks

  3. Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker

    Time frame: Almost daily during first 8 weeks

  4. Documenting the occurrence of mixed Mycobacterium tuberculosis strain infections

    Time frame: Almost daily during first 8 weeks

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania
  • Kilimanjaro Christian Medical Centre, Tanzania
  • National Institute for Public Health and the Environment (RIVM)
  • Sanofi
  • University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.

Acronym: High RIF

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2008
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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