Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216333
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2005-09-20
Brief Title:
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
Sponsor:
International Union Against Tuberculosis and Lung Diseases
Organization:
International Union Against Tuberculosis and Lung Diseases
Study Overview
Official Title:
International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of fixed-dose combined FDC drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease The Union and the World Health Organisation The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy reducing the risk of incorrect dosage simplifying procurement and prescribing practices aiding adherence and facilitating directly observed treatment Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results In this study we are testing the efficacy of this compound when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid
Detailed Description:
This is a multiple country multicenter study using the parallel group open-label randomised trial design The primary objective of this investigation is to assess the efficacy acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs
Patients will be allocated at random either
an initial intensive phase of eight weeks of daily ethambutol isoniazid rifampicin and pyrazinamide in a fixed dose COMBINED tablet followed by 18 weeks of rifampicin and isoniazid in a fixed dose combined tablet three times a week 2COMB4RH3 or
the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks followed by 18 weeks of rifampicin and isoniazid in a fixed dose combined tablet three times a week 2SEPA4RH3
Patients will be allocated at random either
an initial intensive phase of eight weeks of daily ethambutol isoniazid rifampicin and pyrazinamide in a fixed dose COMBINED tablet followed by 18 weeks of rifampicin and isoniazid in a fixed dose combined tablet three times a week 2COMB4RH3 or
the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks followed by 18 weeks of rifampicin and isoniazid in a fixed dose combined tablet three times a week 2SEPA4RH3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None