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

NCT00643292 | Completed Phase 3

• 1 other identifier: A0661073
• Study Type: interventional
• Target: 902
• Locations: 13 countries
• Sites: 47

Brief Summary

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

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

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

  Test of Cure (TOC) visit (Day 12-14)

Secondary Outcomes (11)

• summary of baseline susceptibilities

  Study endpoint

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

  On-Treatment (OT) visit (Day 4-6)

• Laboratory abnormalities

  Baseline and TOC visit

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

  TOC visit

• adverse events

  Continuous

Study Arms (2)

1

EXPERIMENTAL

Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)

2

EXPERIMENTAL

Drug: azithromycin SR

Interventions

amoxicillin/clavulanate postassium (Augmentin ES-600) DRUG

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

1

azithromycin SR DRUG

azithromycin SR 60 mg/kg x 1 dose

2

Eligibility Criteria

• Age: 3 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (48)

Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72202, United States

Location

Pfizer Investigational Site

Bellflower, California, 90706, United States

Location

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Fresno, California, 93710, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

Huntington Beach, California, 92647, United States

Location

Pfizer Investigational Site

Newhall, California, 91321, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Paramount, California, 90723, United States

Location

Pfizer Investigational Site

Pico Rivera, California, 90660, United States

Location

Pfizer Investigational Site

Bridgeport, Connecticut, 06606, United States

Location

Pfizer Investigational Site

Hartford, Connecticut, 06106, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60625, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60630, United States

Location

Pfizer Investigational Site

Evanston, Illinois, 60202, United States

Location

Pfizer Investigational Site

Bardstown, Kentucky, 40004, United States

Location

Pfizer Investigational Site

Springfield, Kentucky, 40069, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75234, United States

Location

Pfizer Investigational Site

Payson, Utah, 84651, United States

Location

Pfizer Investigational Site

Springville, Utah, 84663, United States

Location

Pfizer Investigational Site

Vienna, Virginia, 22180, United States

Location

Pfizer Investigational Site

Buenos Aires, C1405DCR, Argentina

Location

Pfizer Investigational Site

Independencia, Santiago Metropolitan, Chile

Location

Pfizer Investigational Site

Recoleta, Santiago Metropolitan, Chile

Location

Pfizer Investigational Site

Santiago, Chile

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

Santo Domingo, DN, 002, Dominican Republic

Location

Pfizer Investigational Site

Pärsti Vald, Viljandimaa, 71024, Estonia

Location

Pfizer Investigational Site

Rakvere, 44310, Estonia

Location

Pfizer Investigational Site

Tallinn, 13419, Estonia

Location

Pfizer Investigational Site

Tartu, 51014, Estonia

Location

Pfizer Investigational Site

Guatemala City, Departamento de Guatemala, Guatemala

Location

Pfizer Investigational Site

Haifa, 31096, Israel

Location

Pfizer Investigational Site

Jerusalem, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Tel Litwinsky, 52621, Israel

Location

Pfizer Investigational Site

Chihuahua City, Chihuahua, 31020, Mexico

Location

Pfizer Investigational Site

Panama City, Panama

Location

Pfizer Investigational Site

Chorzów, 41-500, Poland

Location

Pfizer Investigational Site

Lublin, 20-093, Poland

Location

Pfizer Investigational Site

Moscow, 117049, Russia

Location

Pfizer Investigational Site

Moscow, 123514, Russia

Location

Pfizer Investigational Site

Smolensk, 214019, Russia

Location

Pfizer Investigational Site

Košice, Slovakia, 040 11, Slovakia

Location

Pfizer Investigational Site

Martin, Slovakia, 036 01, Slovakia

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: January 1, 2003
• Study Completion: May 1, 2004
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

CL (3); SL (2); ES (4); GU (1); ME (1); PL (2); AR (1); DO (1); US (23); CO (1); PA (1); RU (3); IL (4)