Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Completed

CT.gov ID

NCT01364324

Collaborator

(none)

Enrollment

Location

117

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis Tuberculosis, Pulmonary Early Gastric Cancer	Drug: standard first line anti-TB drugs

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 Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Gastrectomy Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally	Drug: standard 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 Other Names: Pharmacokinetics of Anti-tuberculosis Drugs
Non-gastrectomy Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally	Drug: standard 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 Other Names: Pharmacokinetics of Anti-tuberculosis Drugs

Arm

Intervention/Treatment

Gastrectomy

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

Drug: standard 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

Other Names:

Pharmacokinetics of Anti-tuberculosis Drugs

Non-gastrectomy

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

Drug: standard 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

Other Names:

Pharmacokinetics of Anti-tuberculosis Drugs

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age greater than 18 years and less than 80 years
pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)

Exclusion Criteria:

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
patients with AIDS or hypoalbuminemia(albumin < 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
follow-up loss before completion of anti-TB treatment
any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group