Acute Otitis MediaPhase 4NCT00645112
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
A Phase 4 study testing cefdinir (Omnicef) and azithromycin in people with Acute Otitis Media, run by Abbott at 30 sites in United States.
Trial summary
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- cefdinir (Omnicef) and azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 30 sitesUnited States
- Study dates
- Nov 2003to Jan 2004
- Phase
- Phase 4
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis, documented by medical history and physical examination, is AOM I 1 week.
- Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the external auditory canal (following acute perforation of the tympanic membrane).
- At least two (2) of the following signs are present in at least one ear: Full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
- Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results.
- Subject must be a suitable candidate for oral antibiotic therapy.
Who cannot join
- Previous enrollment in this study.
- Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
- Presence of tympanostorny tubes or otitis externa at Evaluation 1.
- Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1 or during the study.
- Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.
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- Concomitant infection that requires additional antimicrobial therapy.
- Evidence of chronic, suppurative otitis media.
- Evidence of perforation of the tympanic membrane > 24 hours.
- Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
- Immunocompromised subject (e.g., neutropenic subjects).
- Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
- Any expectation that treatment with probenecid will be expected during the study drug administration period.
- Known significant renal or hepatic impairment.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Study site
Bardstown, Kentucky, 40004
Study site
Cadillac, Michigan, 49601
Study site
Charleston, South Carolina, 29425
Study site
Columbiana, Alabama, 35051
Study site
Columbus, Ohio, 43205
Study site
Dubuque, Iowa, 52002
Study site
Fresno, California, 93710
Study site
Fresno, California, 93720
Study site
Huber Heights, Ohio, 45424
Study site
Kalamazoo, Michigan, 49008
Study site
Kingsport, Tennessee, 37664
Study site
Lake Jackson, Texas, 77566
Study site
Louisville, Kentucky, 40207
Study site
Marietta, Georgia, 30062
Study site
Monroe, Wisconsin, 53566
Study site
Montgomery, Alabama, 36116
Study site
Omaha, Nebraska, 68178
Study site
Owensboro, Kentucky, 42303
Study site
Ozark, Alabama, 36360
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Portage, Michigan, 49024
Study site
Reading, Pennsylvania, 19606
Study site
Richland, Michigan, 49083
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
Sellersville, Pennsylvania, 18960
Study site
Stone Mountain, Georgia, 30087
Study site
Vienna, Virginia, 22180
Study site
West Jordan, Utah, 84008
Study site
West Jordan, Utah, 84084
About this study
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
- Conditions
- Acute Otitis Media
- Being tested
- cefdinir (Omnicef), azithromycin
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefdinir (Omnicef)Drug
Also called ABT-198, Omnicef, cefdinir
oral suspension, 7 mg/kg every 12 hours for 5 days
azithromycinDrug
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Not described Receives: Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at Evaluation 2
Measured: 9 days
Secondary outcomes (1)
Sustained clinical cure rate at Evaluation 4
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startNov 2003
- Primary completionJan 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645112
- Sponsor's protocol ID
- M03-630
- Status last verified
- Mar 2008
- First submitted
- 22 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00645112
- Acronym / sponsor ID
- M03-630
- Conditions
- Acute Otitis Media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jan 2004 (actual)
- First posted
- 27 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.
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Drug: azithromycin |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis, documented by medical history and physical examination, is AOM I 1 week.
- Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the external auditory canal (following acute perforation of the tympanic membrane).
- At least two (2) of the following signs are present in at least one ear: Full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
- Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results.
- Subject must be a suitable candidate for oral antibiotic therapy.
Key exclusion criteria (14 listed)
- Previous enrollment in this study.
- Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
- Presence of tympanostorny tubes or otitis externa at Evaluation 1.
- Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1 or during the study.
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 |
|---|---|---|
| cefdinir (Omnicef)Also: ABT-198, Omnicef, cefdiniroral suspension, 7 mg/kg every 12 hours for 5 days | Drug | 1 |
| azithromycinoral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days. | Drug | 2 |
Primary outcome
Clinical cure rate at Evaluation 2
Time frame: 9 days
1 secondary outcome
Sustained clinical cure rate at Evaluation 4
Time frame: 25 days
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 27 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefdinir (Omnicef) and azithromycin in people with Acute Otitis Media, run by Abbott at 30 sites in United States.
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 5 inclusion and 14 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 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 cure rate at Evaluation 2 (time frame: 9 days). 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 27 Mar 2008.