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Trial record 14 of 54 for:    moxifloxacin tuberculosis

Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306319
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : November 12, 2020
Information provided by:
Radboud University

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

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: moxifloxacin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia
Study Start Date : January 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306319

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Rumah Sakit Hasan Sadikin (RSHS)
Bandung, Indonesia
Sponsors and Collaborators
Radboud University
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Principal Investigator: R. Aarnoutse, PharmD PhD Radboud University (RUNMC)
Publications of Results:
Layout table for additonal information Identifier: NCT00306319    
Other Study ID Numbers: UMCN-AKF 05.02
Primo study
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Keywords provided by Radboud University:
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents