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MULTICENTRIC, OPEN, RANDOMIZED, COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TELITROMYCIN 800 MG VIA ORAL ONCE A DAY FOR 5 DAYS VS. AMOXICILLINE / CLAVULIC ACID 500/125 MG VIA ORAL THREE TIMES A DAY FOR 10 DAYS IN THE TREATMENT OF ACUTE MAXILAR SYNTHETIS OR MAXILAR-ACUTE ETHIOIDAL IN ADULTS.

MULTICENTRIC, OPEN, RANDOMIZED, COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TELITROMYCIN 800 MG VIA ORAL ONCE A DAY FOR 5 DAYS VS. AMOXICILLINE / CLAVULIC ACID 500/125 MG VIA ORAL THREE TIMES A DAY FOR 10 DAYS IN THE TREATMENT OF ACUTE MAXILAR SYNTHETIS OR MAXILAR-ACUTE ETHIOIDAL IN ADULTS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-040-02
Enrollment
420
Registered
2004-05-29
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

Telitromicina 800 mg Type of group
Telithromycin 800 mg is administered orally once a day for 5 days. Group name:Amoxicillin / clavulamic acid 500/125 mg Type of group
Amoxicillin / clavulamic acid 500/125 mg administered orally three times a day for 10 days

Sponsors

AVENTIS PHARMA S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Be 18 years old and have a diagnosis of acute maxillary sinusitis or acute maxillary-ethmoidal uncomplicated.

Exclusion criteria

Exclusion criteria: Patients who have had at least 3 episodes of maxillary sinusitis acute or maxilar-ethmoidal acute in the last 12 months.

Design outcomes

Secondary

MeasureTime frame
Outcome name:Clinical and radiological response in the late post-treatment visit Measure:Clinical and radiological response in the late post-treatment visit Timepoints:35 day—

Primary

MeasureTime frame
Outcome name:The clinical response in the visit of the Healing Test Measure:The clinical response in the visit of the Healing Test Timepoints:15 day—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)