TuberculosisPhase 2FASTFOODNCT02121314
HRZE Fasted/Fed in Newly Diagnosed TB
A Phase 2 study testing intravenous administration of 1st line TB drugs, day 1 in people with Tuberculosis, run by University Medical Center Groningen at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- intravenous administration of 1st line TB drugs, day 1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with TB who are starting with HRZE therapy
- Age > 18 years old
- Written informed consent
Who cannot join
- Use of antacids, which cannot be discontinued for study days
- Active, unstable hepatic disease (with jaundice, HRZ)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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?
Read the detailed description
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
- Conditions
- Tuberculosis
- Being tested
- intravenous administration of 1st line TB drugs, day 1
- Keywords
- TB, bioavailability, HRZE, fasting, fed
- Medical subject headings
- Tuberculosis, Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous administration of 1st line TB drugs, day 1Drug
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: intravenous administration of 1st line TB drugs, day 1 |
| 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 Receives: Drug: intravenous administration of 1st line TB drugs, day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 11 time points, 3 consecutive days - wk 1 & 8
Secondary outcomes (1)
To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not
tolerance - acceptance; vomiting, refusal
Measured: week 1 - week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen, Gadjah Mada University
- Responsible party
- Principal investigator, Tjip van der Werf, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121314
- Sponsor's protocol ID
- UGM-RuG-UMCG-TB-001
- Acronym
- FASTFOOD
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30997650Saktiawati 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.
PubMed 26661397
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients
- ClinicalTrials.gov ID
- NCT02121314
- Acronym / sponsor ID
- FASTFOOD / UGM-RuG-UMCG-TB-001
- Conditions
- Tuberculosis
- Keywords
- TB, bioavailability, HRZE, fasting, fed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen, Gadjah Mada University
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting-Fed | Active comparator | Drug: intravenous administration of 1st line TB drugs, day 1blood 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 | Drug: intravenous administration of 1st line TB drugs, day 1blood 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with TB who are starting with HRZE therapy
- Age > 18 years old
- Written informed consent
Key exclusion criteria (2 listed)
- Use of antacids, which cannot be discontinued for study days
- Active, unstable hepatic disease (with jaundice, HRZ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous administration of 1st line TB drugs, day 1TB drugs IV on day 1 for calculation of bioavailability while fasting or fed | Drug | Fasting-Fed, Fed-Fasting |
Primary outcome
pharmacokinetics
Time frame: 3 days - week 1 and week 8
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
pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE
Time frame: 11 time points, 3 consecutive days - wk 1 & 8
PK curves from venous blood specimens sampled from indwelling venous catheter
1 secondary outcome
To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not
Time frame: week 1 - week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Derived from this study: PubMed 30997650Saktiawati 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.
- Derived from this study: PubMed 26661397Saktiawati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravenous administration of 1st line TB drugs, day 1 in people with Tuberculosis, run by University Medical Center Groningen at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics (time frame: 3 days - week 1 and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.