Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis

Keywords

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Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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R. Aarnoutse, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University (RUNMC)

Locations

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Rumah Sakit Hasan Sadikin (RSHS)

Bandung, , Indonesia

Site Status

Countries

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Indonesia

References

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Nijland HM, Ruslami R, Suroto AJ, Burger DM, Alisjahbana B, van Crevel R, Aarnoutse RE. Rifampicin reduces plasma concentrations of moxifloxacin in patients with tuberculosis. Clin Infect Dis. 2007 Oct 15;45(8):1001-7. doi: 10.1086/521894. Epub 2007 Sep 4.

Reference Type RESULT

PMID: 17879915 (View on PubMed)

Other Identifiers

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Primo study

Identifier Type: -

Identifier Source: secondary_id

UMCN-AKF 05.02