Clinical trial · Observational
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
NCT01364324CI-TRIAL-00047331completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Tuberculosis | — | UNRESOLVED | — |
| Tuberculosis, Pulmonary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard first line anti-TB drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Gastrectomy
- description
- Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
- interventionNames
- Drug: standard first line anti-TB drugs
- label
- Non-gastrectomy
- description
- Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
- interventionNames
- Drug: standard first line anti-TB drugs
Primary outcomes (1)
- measure
- The change in the maximum concentration (Cmax) of first-line TB drugs
- timeFrame
- Before and 1, 2, 4, 6 and 8 hours after dosing
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.