Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

National Cancer Center, Korea40 enrolled

Overview

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).

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

OBSERVATIONAL

Enrollment

Conditions

Tuberculosis Tuberculosis, Pulmonary Early Gastric Cancer

Interventions

standard first line anti-TB drugsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Respiratory Clinic, National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Time frame: 9month after anti-TB treatment

Data from ClinicalTrials.gov

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