Tuberculosis Clinical Trial
— FASTFOODOfficial title:
The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients
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?
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with TB who are starting with HRZE therapy - Age > 18 years old - Written informed consent Exclusion Criteria: - Use of antacids, which cannot be discontinued for study days - Active, unstable hepatic disease (with jaundice, HRZ) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Sardjito Central Hospital | Yogyakarta |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Gadjah Mada University, University of Groningen |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. BMI, i.e. body weight and length age gender ethnicity co-morbidity, for instance HIV/AIDS, diabetes (only at start) co-medication: especially HIV medication, prednisolone (may lower INH concentration), antacids (may lower absorption of HRE concentration) chemistry: liver function, renal function, hemoglobulin, albumin, bilirubin pharmacogenetics |
weeks 1 and 8 | Yes |
Primary | 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 | No |
Primary | 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 | No |
Secondary | To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not | tolerance - acceptance; vomiting, refusal | week 1 - week 8 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |