Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Tuberculosis Clinical Trial

Official title:

Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364324
• Other study ID #: NCCCTS-10-493
• Status: Completed
• Start date: September 2010
• Est. completion date: June 2020

Study information

• Verified date: September 2020
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Tuberculosis
• Tuberculosis, Pulmonary

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

Locations

Country	Name	City	State
Korea, Republic of	Respiratory Clinic, National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the maximum concentration (Cmax) of first-line TB drugs		Before and 1, 2, 4, 6 and 8 hours after dosing
Secondary	The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug	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.	9month after anti-TB treatment