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Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

This study is currently recruiting participants.
Verified February 2011 by National Cancer Center, Korea
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01364324
First received: May 23, 2011
Last updated: June 1, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Tuberculosis
Tuberculosis, Pulmonary
Early Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug [ Time Frame: 9month after anti-TB treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastrectomy
Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
Non-gastrectomy
Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364324

Contacts
Contact: Hee Seok Lee, M.D. +82-31-920-1749 jekyde@yahoo.co.kr

Locations
Korea, Republic of
Center for Lung Cancer, National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Hee Seok Lee, M.D.     +82-31-920-1749     jekyde@yahooo.co.kr    
Principal Investigator: Hee Seok Lee, M.D.            
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Hee Seok Lee, M.D. National Cancer Center
  More Information

No publications provided

Responsible Party: Hee Seok Lee, M.D., National Cancer Center, Center for Lung Cancer and Division of Pulmonary Medicine
ClinicalTrials.gov Identifier: NCT01364324     History of Changes
Other Study ID Numbers: NCCCTS-10-493
Study First Received: May 23, 2011
Last Updated: June 1, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
tuberculosis
pharmacokinetics
first-line drugs
gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Tuberculosis
Tuberculosis, Pulmonary
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Mycobacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013