Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Tracking Information
First Submitted Date	May 23, 2011
First Posted Date	June 2, 2011
Last Update Posted Date	April 13, 2017
Study Start Date	September 2010
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 1, 2011)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01364324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: June 1, 2011)	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.
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Official Title	Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
Brief Summary	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).
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.
Study Type	Observational
Study Design	Observational Model: Case-Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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)
Condition	Tuberculosis; Tuberculosis, Pulmonary; Early Gastric Cancer
Intervention	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
Study Groups/Cohorts	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: June 1, 2011)	40
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	June 2019
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact: Hee Seok Lee, M.D. +82-31-920-1749 jekyde7@gmail.com
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01364324
Other Study ID Numbers	NCCCTS-10-493
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hee Seok Lee, National Cancer Center, Korea
Study Sponsor	National Cancer Center, Korea
Collaborators	Not Provided
Investigators	Principal Investigator: Hee Seok Lee, M.D. National Cancer Center
PRS Account	National Cancer Center, Korea
Verification Date	April 2017