Respiratory Clinic, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
NCT Number: NCT01364324
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).
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Notify Me18 year–80 year
All sexes
Observational
Goyang-si, Gyeonggi-do, 410-769, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Pharmacokinetics of Anti-tuberculosis Drugs
Time frame: Before and 1, 2, 4, 6 and 8 hours after dosing
Time frame: 9month after anti-TB treatment
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.
National Cancer Center, Korea
Other Gov
Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
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