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Completed

NCT Number: NCT00643292

A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

3 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included

Exclusion criteria

Patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.

Treatment and study plan

amoxicillin/clavulanate postassium (Augmentin ES-600)

Drug

amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days

Azithromycin SR

Drug

azithromycin SR 60 mg/kg x 1 dose

Primary outcomes

  1. clinical response (cure or failure) in the Clinical Per Protocol population

    Time frame: Test of Cure (TOC) visit (Day 12-14)

Secondary outcomes

  1. summary of baseline susceptibilities

    Time frame: Study endpoint

  2. clinical response (cure or failure) in the Clinical Per Protocol population

    Time frame: On-Treatment (OT) visit (Day 4-6)

  3. Laboratory abnormalities

    Time frame: Baseline and TOC visit

  4. bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population

    Time frame: TOC visit

  5. adverse events

    Time frame: Continuous

  6. clinical response (cure or failure) in all populations except the Clinical Per Protocol population

    Time frame: OT visit and TOC visit

  7. clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population

    Time frame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)

  8. clinical response (cure or failure) in the Clinical Per Protocol population

    Time frame: LTFU visit

  9. clinical scores for the Clinical Per Protocol population

    Time frame: OT visit and TOC visit

  10. persistence of middle ear fluid for the Clinical Per Protocol population

    Time frame: TOC visit and LTFU visit

  11. audiologic response

    Time frame: LTFU visit

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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