Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00306319

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 II

MedlinePlus related topics: Tuberculosis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia

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

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

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

Keywords provided by Radboud University:

Tuberculosis

Study placed in the following topic categories:

Bacterial Infections
Rifampin
Gram-Positive Bacterial Infections
Moxifloxacin

Mycobacterium Infections
Tuberculosis
Isoniazid

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Gram-Positive Bacterial Infections
Moxifloxacin
Therapeutic Uses

Mycobacterium Infections
Tuberculosis
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on May 07, 2009