Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Completed

• Conditions: Tuberculosis; Early Gastric Cancer; Tuberculosis, Pulmonary
• Interventions: Drug: standard first line anti-TB drugs

• Registration Number: NCT01364324
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The change in the maximum concentration (Cmax) of first-line TB drugs	Before and 1, 2, 4, 6 and 8 hours after dosing

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Respiratory Clinic, National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of