You are here

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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Otitis Media
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-48 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00643292
Pfizer
Completed
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Otitis Media
NCT00768534
All Genders
0+
Years
Tegernsee, Bavarian
Otitis Media, Myringotomy Tube Insertion, Skin Rash, Trauma
NCT01339546
All Genders
Otitis Media
NCT01199016
All Genders
0+
Years
Multiple Sites
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 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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acute Otitis Media
  • Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
    amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
  • Drug: azithromycin SR
    azithromycin SR 60 mg/kg x 1 dose
  • Experimental: 1
    Intervention: Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
902
May 2004
Not Provided

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.

Sexes Eligible for Study: All
3 Months to 48 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Costa Rica,   Dominican Republic,   Estonia,   Guatemala,   Israel,   Mexico,   Panama,   Poland,   Russian Federation,   Slovakia,   United States
 
 
NCT00643292
A0661073
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now