Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Antitubercular Agents

Criteria

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