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NCT Number: NCT01364324

Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard first line anti-TB drugs

Drug

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

Primary outcomes

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

    Time frame: Before and 1, 2, 4, 6 and 8 hours after dosing

Secondary outcomes

  1. The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2011
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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