Study Results
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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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2013-07-31
2014-06-30
Brief Summary
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Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage of lower drug blood concentrations over time? How exactly do the drug concentrations over time (pharmacokinetics) compare between fasting and fed conditions, especially in the early stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB drugs?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fasting-Fed
blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE as iv therapy; on day 2, HRZE as oral therapy in fasting condition (2 hours before meals); and on day 3 HRZE as oral therapy in fed condition (after meals).
intravenous administration of 1st line TB drugs, day 1
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
Fed-Fasting
blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE therapy as iv therapy; day 2, HRZE as oral therapy in fed condition, and on day 3, HRZE as oral therapy in fasting condition
intravenous administration of 1st line TB drugs, day 1
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
Interventions
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intravenous administration of 1st line TB drugs, day 1
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years old
* Written informed consent
Exclusion Criteria
* Active, unstable hepatic disease (with jaundice, HRZ)
18 Years
ALL
No
Sponsors
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University of Groningen
OTHER
Gadjah Mada University
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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Tjip van der Werf
Professor, Infectious Diseases & Tuberculosis
Locations
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Sardjito Central Hospital
Yogyakarta, , Indonesia
Countries
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References
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Saktiawati AMI, Harkema M, Setyawan A, Subronto YW, Sumardi, Stienstra Y, Aarnoutse RE, Magis-Escurra C, Kosterink JGW, van der Werf TS, Alffenaar JC, Sturkenboom MGG. Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis. Clin Pharmacokinet. 2019 Nov;58(11):1445-1454. doi: 10.1007/s40262-019-00763-3.
Saktiawati AM, Sturkenboom MG, Stienstra Y, Subronto YW, Sumardi, Kosterink JG, van der Werf TS, Alffenaar JW. Impact of food on the pharmacokinetics of first-line anti-TB drugs in treatment-naive TB patients: a randomized cross-over trial. J Antimicrob Chemother. 2016 Mar;71(3):703-10. doi: 10.1093/jac/dkv394. Epub 2015 Dec 11.
Other Identifiers
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UGM-RuG-UMCG-TB-001
Identifier Type: -
Identifier Source: org_study_id
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