Pulmonary TuberculosisTBPKNCT00948077
Pharmacokinetic Study for Anti-tuberculosis Drugs
A study testing Rifater and EMB in people with Pulmonary Tuberculosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Rifater and EMB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Dec 2011
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 20 years
- Karnofsky score of > 50
- Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
- A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
- Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
- Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
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- Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
- The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
- Only subjects who have provided signed and dated written informed consent will be included.
Who cannot join
- Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
- Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
- Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
- Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
- Women who are Pregnant or breastfeeding during the study period.
- Subjects with a known allergy to study drugs
- In the opinion of the investigator to be unsuitable for study participation for any reason.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University- Wan Fang Hospital
Taipei, 116
Ming-Chih Yu, M.D., +886-2-29307930 ext. 52953, yutbc@ms10.hinet.net
Li-Chun Wu, MPH, +886-2-82300120, tar266@ms65.hinet.net
About this study
Official title: A Single-Center, Open-Label, Randomized, Crossover Design Study to Evaluate the Effect of Dietary Status on Pharmacokinetic Profile of Orally Administered First-Line Anti-TB Drugs in Subjects With Pulmonary Tuberculosis
The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.
Read the detailed description
This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.
- Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.
- Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Rifater and EMB
- Keywords
- tuberculosis, pharmacokinetic, first-line drugs
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifater and EMBDrug
The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention.
The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below.
Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast." Receives: Drug: Rifater and EMB |
| Treatment B | Experimental | Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished." Receives: Drug: Rifater and EMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum concentration (Cmax)of first-line TB drugs
Measured: Before and 1, 2, 4, 6 and 10 hours after dosing
Secondary outcomes (1)
N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.
Measured: Before taking the anti-TB drugs on the fifth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Chih MC Yu, M.D., Principal investigator, Taipei Medical University- Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948077
- Sponsor's protocol ID
- 2009WFCRC-08
- Other IDs
- 98040
- Acronym
- TBPK
- Status last verified
- Apr 2011
- First submitted
- 16 Jun 2009
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized, Crossover Design Study to Evaluate the Effect of Dietary Status on Pharmacokinetic Profile of Orally Administered First-Line Anti-TB Drugs in Subjects With Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00948077
- Acronym / sponsor ID
- TBPK / 2009WFCRC-08
- Conditions
- Pulmonary Tuberculosis
- Keywords
- tuberculosis, pharmacokinetic, first-line drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Jul 2009 (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.
The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.
Detailed description
This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.
- Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.
- Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Rifater and EMBStudy agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast." |
| Treatment B | Experimental | Drug: Rifater and EMBStudy agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished." |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than 20 years
- Karnofsky score of > 50
- Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
- A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
- Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
Key exclusion criteria (7 listed)
- Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
- Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
- Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
- Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
- Women who are Pregnant or breastfeeding during the study period.
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 |
|---|---|---|
| Rifater and EMBThe main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day) | Drug | Treatment A, Treatment B |
Primary outcome
The maximum concentration (Cmax)of first-line TB drugs
Time frame: Before and 1, 2, 4, 6 and 10 hours after dosing
1 secondary outcome
N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.
Time frame: Before taking the anti-TB drugs on the fifth day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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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.
Ming-Chih MC Yu, M.D. principal investigator
Taipei Medical University- Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifater and EMB in people with Pulmonary Tuberculosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2011. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Chih MC Yu, M.D. (+886-2-29307930 ext. 52953, yutbc@ms10.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum concentration (Cmax)of first-line TB drugs (time frame: Before and 1, 2, 4, 6 and 10 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2011.