Back to resultsPharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Primary Purpose
Tuberculosis
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring Tuberculosis
Eligibility 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.
Sites / Locations
- Rumah Sakit Hasan Sadikin (RSHS)
Outcomes
Primary Outcome Measures
Pharmacokinetic (24 hrs) curves will be drawn
at day 5 in period I and period II.
Secondary Outcome Measures
Full Information
NCT ID
NCT00306319
First Posted
March 22, 2006
Last Updated
November 9, 2020
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00306319
Brief Title
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Official Title
Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
5. Study Description
Brief Summary
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Primary Outcome Measure Information:
Title
Pharmacokinetic (24 hrs) curves will be drawn
Title
at day 5 in period I and period II.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Aarnoutse, PharmD PhD
Organizational Affiliation
Radboud University (RUNMC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rumah Sakit Hasan Sadikin (RSHS)
City
Bandung
Country
Indonesia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17879915
Citation
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.
Results Reference
result
Learn more about this trial
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
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