Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

National Cancer Center (NCC)

Status: Completed

Conditions: Early Gastric Cancer; Tuberculosis; Tuberculosis, Pulmonary

Treatments: Drug: standard first line anti-TB drugs

Study type: Observational

Funder types: Other

Identifiers

NCT01364324

NCCCTS-10-493

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Gastrectomy

Description:

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

Treatment:

Drug: standard first line anti-TB drugs

Non-gastrectomy

Description:

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

Treatment:

Drug: standard first line anti-TB drugs