Clinical trial NCT01364324: Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Official title: Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Tuberculosis, Pulmonary
Early Gastric Cancer
Keywords: tuberculosis
pharmacokinetics
first-line drugs
gastrectomy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2011-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years)

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.

Eligibility 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

Primary outcomes:
measure: The change in the maximum concentration (Cmax) of first-line TB drugs
timeFrame: Before and 1, 2, 4, 6 and 8 hours after dosing
Secondary outcomes:
measure: The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug
timeFrame: 9month after anti-TB treatment
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Respiratory Clinic, National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Hee Seok Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: