Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Groningen | OTHER |
| Gadjah Mada University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food.
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?
To evaluate the influence of concomitant food ingestion on the pharmacokinetics of HRZE in newly diagnosed TB patients To evaluate the influence of early disease on the PK parameters of HRZE in TB patients To compare the pharmacokinetics of HRZE in the early stage of disease with the pharmacokinetics of HRZE in more stable condition in newly diagnosed TB patients To evaluate adverse events of HRZE in TB patients
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting-Fed | Active Comparator | 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). |
|
| Fed-Fasting | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous administration of 1st line TB drugs, day 1 | Drug | TB drugs IV on day 1 for calculation of bioavailability while fasting or fed |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | pharmacokinetics (AUC0-8, Cmax, and Tmax); comparison between TB patients who take HRZE concomitant with food and TB patients who take HRZE concomitant without food, weeks 1 and 8 of treatment | 3 days - week 1 and week 8 |
| pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE | PK curves from venous blood specimens sampled from indwelling venous catheter | 11 time points, 3 consecutive days - wk 1 & 8 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not | tolerance - acceptance; vomiting, refusal | week 1 - week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| confounding factors for primary and secondary outcomes | Parameters which may influence the pharmacokinetics of HRZE will be measured at start and end of the study.
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sardjito Central Hospital | Yogyakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30997650 | Derived | 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. | |
| 26661397 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D005215 | Fasting |
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| weeks 1 and 8 |
| Derived |
| 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |