Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00306319
First received: March 22, 2006
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.


Condition Intervention Phase
Tuberculosis
Drug: moxifloxacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Pharmacokinetic (24 hrs) curves will be drawn
  • at day 5 in period I and period II.

Estimated Enrollment: 23
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
  • Subject is 18-55 years of age at the day of the first dosing of study medication.
  • Subject has a normal ECG
  • Subjects bodyweight is >35kg
  • Use of rifampicin and isoniazid

Exclusion Criteria:

  • Pregnant or lactating
  • History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
  • Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
  • Subject is not able and/or not willing to sign the informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306319

Locations
Indonesia
Rumah Sakit Hasan Sadikin (RSHS)
Bandung, Indonesia
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: R. Aarnoutse, PharmD PhD Radboud University (RUNMC)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306319     History of Changes
Other Study ID Numbers: UMCN-AKF 05.02, Primo study
Study First Received: March 22, 2006
Last Updated: May 20, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014