Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: March 21, 2016
Last verified: March 2016

May 23, 2011
March 21, 2016
September 2010
December 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01364324 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response 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).
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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)
  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Early Gastric Cancer
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
  • Gastrectomy
    Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
    Intervention: Drug: standard first line anti-TB 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
    Intervention: Drug: standard first line anti-TB drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2019
December 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Hee Seok Lee, M.D. +82-31-920-1749 jekyde7@gmail.com
Korea, Republic of
 
NCT01364324
NCCCTS-10-493
Yes
Not Provided
Not Provided
Hee Seok Lee, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Hee Seok Lee, M.D. National Cancer Center
National Cancer Center, Korea
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP