Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

This study is currently recruiting participants.

Verified February 2011 by National Cancer Center, Korea

Sponsor:

Information provided by:

National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT01364324

First received: May 23, 2011

Last updated: June 1, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 23, 2011

Last Updated Date

June 1, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01364324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug [ Time Frame: 9month after anti-TB treatment ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Official Title ^ICMJE

Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients

Brief 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).

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

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)

Condition ^ICMJE

Tuberculosis
Tuberculosis, Pulmonary
Early Gastric Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Gastrectomy
Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
Non-gastrectomy
Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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)

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hee Seok Lee, M.D.

+82-31-920-1749

jekyde@yahoo.co.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01364324

Other Study ID Numbers ^ICMJE

NCCCTS-10-493

Has Data Monitoring Committee

Yes

Responsible Party

Hee Seok Lee, M.D., National Cancer Center, Center for Lung Cancer and Division of Pulmonary Medicine

Study Sponsor ^ICMJE

National Cancer Center, Korea

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hee Seok Lee, M.D.

National Cancer Center

Information Provided By

National Cancer Center, Korea

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top