Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Recruitment status was Recruiting
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).
Early Gastric Cancer
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients|
- 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 ]
- 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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364324
|Contact: Hee Seok Lee, M.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Center for Lung Cancer, National Cancer Center||Recruiting|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Contact: Hee Seok Lee, M.D. +82-31-920-1749 email@example.com|
|Principal Investigator: Hee Seok Lee, M.D.|
|Principal Investigator:||Hee Seok Lee, M.D.||National Cancer Center|