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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Tuberculosis, Tuberculosis, Pulmonary, Early Gastric Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

The change in the maximum concentration (Cmax) of first-line TB drugs

Outcome Time Frame:

Before and 1, 2, 4, 6 and 8 hours after dosing

Safety Issue:

No

Principal Investigator

Hee Seok Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS-10-493

NCT ID:

NCT01364324

Start Date:

September 2010

Completion Date:

September 2013

Related Keywords:

  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Early Gastric Cancer
  • tuberculosis
  • pharmacokinetics
  • first-line drugs
  • gastrectomy
  • Stomach Neoplasms
  • Tuberculosis
  • Tuberculosis, Pulmonary

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