Acute Otitis MediaPhase 3NCT00643292
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 study testing amoxicillin/clavulanate postassium (Augmentin ES-600) and azithromycin SR in people with Acute Otitis Media, run by Pfizer at 48 sites in 14 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 48 months
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- amoxicillin/clavulanate postassium (Augmentin ES-600) and azithromycin SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 902 participants
- Where
- 48 sitesin 14 countries
- Study dates
- Jan 2003to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included
Who cannot join
- 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.
Trial locations and contacts
48 sites in 14 countries.
48 sites in 14 countries
United States23 sites
Pfizer Investigational Site
Bardstown, Kentucky, 40004
Pfizer Investigational Site
Bellflower, California, 90706
Pfizer Investigational Site
Bridgeport, Connecticut, 06606
Pfizer Investigational Site
Chicago, Illinois, 60625
Pfizer Investigational Site
Chicago, Illinois, 60630
Pfizer Investigational Site
Dallas, Texas, 75234
Pfizer Investigational Site
Evanston, Illinois, 60202
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Hartford, Connecticut, 06106
Pfizer Investigational Site
Huntington Beach, California, 92647
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Little Rock, Arkansas, 72202
Pfizer Investigational Site
Newhall, California, 91321
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Payson, Utah, 84651
Pfizer Investigational Site
Pico Rivera, California, 90660
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Springfield, Kentucky, 40069
Pfizer Investigational Site
Springville, Utah, 84663
Pfizer Investigational Site
Vienna, Virginia, 22180
Estonia4 sites
Pfizer Investigational Site
Pärsti Vald, Viljandimaa, 71024
Pfizer Investigational Site
Rakvere, 44310
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tartu, 51014
Israel4 sites
Pfizer Investigational Site
Haifa, 31096
Pfizer Investigational Site
Jerusalem
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Tel HaShomer, 52621
Chile3 sites
Pfizer Investigational Site
Independencia, Santiago Metropolitan
Pfizer Investigational Site
Recoleta, Santiago Metropolitan
Pfizer Investigational Site
Santiago
Russia3 sites
Pfizer Investigational Site
Moscow, 117049
Pfizer Investigational Site
Moscow, 123514
Pfizer Investigational Site
Smolensk, 214019
Poland2 sites
Pfizer Investigational Site
Chorzów, 41-500
Pfizer Investigational Site
Lublin, 20-093
Slovakia2 sites
Pfizer Investigational Site
Košice, Slovakia, 040 11
Pfizer Investigational Site
Martin, Slovakia, 036 01
Costa Rica1 site
Pfizer Investigational Site
San José, Provincia de San José
Dominican Republic1 site
Pfizer Investigational Site
Santo Domingo, DN, 002
Guatemala1 site
Pfizer Investigational Site
Guatemala City, Departamento de Guatemala
Location not given1 site
Pfizer Investigational Site
About this study
Official 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
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
- Being tested
- amoxicillin/clavulanate postassium (Augmentin ES-600), azithromycin SR
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SRDrug
azithromycin SR 60 mg/kg x 1 dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: amoxicillin/clavulanate postassium (Augmentin ES-600) |
| 2 | Experimental | Not described Receives: Drug: azithromycin SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response (cure or failure) in the Clinical Per Protocol population
Measured: Test of Cure (TOC) visit (Day 12-14)
Secondary outcomes (11)
summary of baseline susceptibilities
Measured: Study endpoint
clinical response (cure or failure) in the Clinical Per Protocol population
Measured: On-Treatment (OT) visit (Day 4-6)
Laboratory abnormalities
Measured: Baseline and TOC visit
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
Measured: TOC visit
adverse events
Measured: Continuous
clinical response (cure or failure) in all populations except the Clinical Per Protocol population
Measured: OT visit and TOC visit
clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population
Measured: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)
clinical response (cure or failure) in the Clinical Per Protocol population
Measured: LTFU visit
clinical scores for the Clinical Per Protocol population
Measured: OT visit and TOC visit
persistence of middle ear fluid for the Clinical Per Protocol population
Measured: TOC visit and LTFU visit
audiologic response
Measured: LTFU visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643292
- Sponsor's protocol ID
- A0661073
- Status last verified
- May 2011
- First submitted
- 19 Mar 2008
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00643292
- Acronym / sponsor ID
- A0661073
- Conditions
- Acute Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 902 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- May 2004 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amoxicillin/clavulanate postassium (Augmentin ES-600) |
| 2 | Experimental | Drug: azithromycin SR |
Who may qualify
- Ages
- 3 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin/clavulanate postassium (Augmentin ES-600)amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days | Drug | 1 |
| azithromycin SRazithromycin SR 60 mg/kg x 1 dose | Drug | 2 |
Primary outcome
clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 12-14)
11 secondary outcomes
summary of baseline susceptibilities
Time frame: Study endpoint
clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: On-Treatment (OT) visit (Day 4-6)
Laboratory abnormalities
Time frame: Baseline and TOC visit
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
Time frame: TOC visit
adverse events
Time frame: Continuous
clinical response (cure or failure) in all populations except the Clinical Per Protocol population
Time frame: OT visit and TOC visit
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)
clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: LTFU visit
clinical scores for the Clinical Per Protocol population
Time frame: OT visit and TOC visit
persistence of middle ear fluid for the Clinical Per Protocol population
Time frame: TOC visit and LTFU visit
audiologic response
Time frame: LTFU visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
48 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amoxicillin/clavulanate postassium (Augmentin ES-600) and azithromycin SR in people with Acute Otitis Media, run by Pfizer at 48 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Estonia, Israel, Chile, Russia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response (cure or failure) in the Clinical Per Protocol population (time frame: Test of Cure (TOC) visit (Day 12-14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.