Early Gastric Cancer, Tuberculosis, Tuberculosis, Pulmonary
Conditions
Keywords
tuberculosis, pharmacokinetics, first-line drugs, gastrectomy
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.
Interventions
DRUGstandard first line anti-TB 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
Sponsors
National Cancer Center, Korea
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years and less than 80 years 2. pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR 3. usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)
Exclusion criteria
1. 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 2. patients with AIDS or hypoalbuminemia(albumin \< 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs 3. patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin) 4. patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs 5. discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance 6. follow-up loss before completion of anti-TB treatment 7. any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the maximum concentration (Cmax) of first-line TB drugs | Before and 1, 2, 4, 6 and 8 hours after dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug | 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. |
Countries
South Korea
Outcome results
None listed