Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Hee Seok Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01364324
First received: May 23, 2011
Last updated: April 13, 2015
Last verified: April 2015
  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 Intervention
Tuberculosis
Tuberculosis, Pulmonary
Early Gastric Cancer
Drug: standard first line anti-TB drugs

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:


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: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Pharmacokinetics of Anti-tuberculosis 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Hee Seok Lee, M.D. +82-31-920-1749 jekyde7@gmail.com

Locations
Korea, Republic of
Respiratory Clinic, National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Hee Seok Lee, M.D.    +82-31-920-1749    jekyde7@gmail.com   
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, Pulmonologist, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01364324     History of Changes
Other Study ID Numbers: NCCCTS-10-493
Study First Received: May 23, 2011
Last Updated: April 13, 2015
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Mycobacterium Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 26, 2015