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INTERNATIONAL MULTICENTRIC TEST FOR THE EVALUATION OF A COMBINED TABLET OF FOUR DRUGS AT DAILY FIXED DOSE IN THE INTENSIVE INITIAL PHASE (2 MONTHS) OF CHEMOTHERAPY FOLLOWED BY A COMBINED TABLET OF TWO DRUGS AT A FIXED DOSE THREE TIMES A WEEK IN THE CONTINUATION PHASE (4 MONTHS) FOR THE TREATMENT OF PULMONARY TUBERCULOSIS

INTERNATIONAL MULTICENTRIC TEST FOR THE EVALUATION OF A COMBINED TABLET OF FOUR DRUGS AT DAILY FIXED DOSE IN THE INTENSIVE INITIAL PHASE (2 MONTHS) OF CHEMOTHERAPY FOLLOWED BY A COMBINED TABLET OF TWO DRUGS AT A FIXED DOSE THREE TIMES A WEEK IN THE CONTINUATION PHASE (4 MONTHS) FOR THE TREATMENT OF PULMONARY TUBERCULOSIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-093-03
Enrollment
Unknown
Registered
2004-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Combined tablet Type of group
The initial eight-week intensive phase of ethambutol, isoniazid, rifampicin and pyrazinamide in a COMBINED tablet in a fixed daily dose, followed by 18 weeks of rifampicin and isoniazid in a fixed-dose combination tablet three times a week. Group name:Separate tablets Type of group
The same drugs will be delivered in SEPARATE formulations in the initial eight-week phase, followed by 18 weeks of rifampicin and isoniazid in a fixed-dose combination tablet three times a week.

Sponsors

Union Internacional contra TBC y enfermedades pulmonares,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Not contemplated

Exclusion criteria

Exclusion criteria: Not contemplated

Design outcomes

Primary

MeasureTime frame
Outcome name:Combined rate of failures at the end of treatment (6th month) and relapses in a period of 24 months (30th month). Measure:Efficacy, acceptability and toxicity of two chemotherapy regimens in patients diagnosed for the first time with pulmonary tuberculosis. Timepoints:6 month—

Secondary

MeasureTime frame
Outcome name:• Sputum culture results after two months. • Results of sputum smear microscopy at two months. • Rate of completion of chemotherapy according to the protocol. • Number of chemotherapy doses ingested under observation. Measure:Efficacy, acceptability and toxicity of two chemotherapy regimens in patients diagnosed for the first time with pulmonary tuberculosis. Timepoints:2 month—

Countries

Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Guatemala, Peru, United States, Uruguay, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)