TuberculosisNCT01364324
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Early Gastric Cancer
- What is being tested?
- standard first line anti-TB drugs
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Jun 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years)
Who may be able to join
- Age greater than 18 years and less than 80 years
- pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
- usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)
Who cannot join
- patients with liver disease (bilirubin ≥ 1.5 mg/d or AST ≥ 2 x normal upper limit) or chronic renal failure (Cr ≥ 2.0 mg/d) who cannot use first-line anti-TB drugs
- patients with AIDS or hypoalbuminemia(albumin < 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
- patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
- patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
- discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
- follow-up loss before completion of anti-TB treatment
- any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Respiratory Clinic, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).
Read the detailed description
Gastrectomy is a well-known risk factor for TB. Also, there were some reports about malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of recently used first line anti-TB drugs in the gastrectomized patients have not been well evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary TB through this study.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Early Gastric Cancer
- Being tested
- standard first line anti-TB drugs
- Keywords
- tuberculosis, pharmacokinetics, first-line drugs, gastrectomy
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard first line anti-TB drugsDrug
Also called Pharmacokinetics of Anti-tuberculosis Drugs
We will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy | Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally Receives: Drug: standard first line anti-TB drugs | |
| Non-gastrectomy | Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally Receives: Drug: standard first line anti-TB drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the maximum concentration (Cmax) of first-line TB drugs
Measured: Before and 1, 2, 4, 6 and 8 hours after dosing
Secondary outcomes (1)
The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug
Treatment duration can be varied according to several factors such as a first TB episode or not, cavitary TB, and AFB culture(+) after 2month-treatment etc. We will plan 6 or 9 months treatment for each patient according to these factors. During treatment period, we will check chest radiographs and sputum AFB smear/culture with every 2-3month intervals. At 9month after treatment, we will evaluate the effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug by taking account of improvement on chest radiograph and negative conversion and its continuation on sputum smear/culture.
Measured: 9month after anti-TB treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hee Seok Lee, National Cancer Center, Korea
- Investigators
- Hee Seok Lee, M.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364324
- Sponsor's protocol ID
- NCCCTS-10-493
- Status last verified
- Sep 2020
- First submitted
- 23 May 2011
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
- ClinicalTrials.gov ID
- NCT01364324
- Acronym / sponsor ID
- NCCCTS-10-493
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Early Gastric Cancer
- Keywords
- tuberculosis, pharmacokinetics, first-line drugs, gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Sep 2010
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 2 Jun 2011 (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 gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).
Detailed description
Gastrectomy is a well-known risk factor for TB. Also, there were some reports about malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of recently used first line anti-TB drugs in the gastrectomized patients have not been well evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary TB through this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy | – | Drug: standard first line anti-TB drugsTwenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally |
| Non-gastrectomy | – | Drug: standard first line anti-TB drugsTwenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years)
Key inclusion criteria (3 listed)
- Age greater than 18 years and less than 80 years
- pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
- usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)
Key exclusion criteria (7 listed)
- patients with liver disease (bilirubin ≥ 1.5 mg/d or AST ≥ 2 x normal upper limit) or chronic renal failure (Cr ≥ 2.0 mg/d) who cannot use first-line anti-TB drugs
- patients with AIDS or hypoalbuminemia(albumin < 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
- patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
- patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
- discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
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 |
|---|---|---|
| standard first line anti-TB drugsAlso: Pharmacokinetics of Anti-tuberculosis DrugsWe will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB | Drug | Gastrectomy, Non-gastrectomy |
Primary outcome
The change in the maximum concentration (Cmax) of first-line TB drugs
Time frame: Before and 1, 2, 4, 6 and 8 hours after dosing
1 secondary outcome
The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug
Time frame: 9month after anti-TB treatment
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 25 Sep 2020.
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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.
Hee Seok Lee, M.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by National Cancer Center, Korea at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 25 Sep 2020. 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 South Korea. 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?
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?
The change in the maximum concentration (Cmax) of first-line TB drugs (time frame: Before and 1, 2, 4, 6 and 8 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 25 Sep 2020.