Acute Otitis MediaPhase 4NCT00644943
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
A Phase 4 study testing cefdinir (Omnicef) and amoxicillin in people with Acute Otitis Media, run by Abbott at 32 sites in United States.
Trial summary
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 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 amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 32 sitesUnited States
- Study dates
- Feb 2003to Apr 2003
- 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 acute otitis media <=1 week
- Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
- At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
- Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
- Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results
Who cannot join
- Previous enrollment in this study.
- Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
- Presence of tympanostomy tubes or otitis externa at Evaluation 1.
- Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) 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 a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
- Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
- Known, severe renal impairment (i.e., creatinine clearance < 30 mUmid1.73 m2).
- History of Augmentin-associated cholestatic jaundicehepatic dysfunction.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Austin, Texas, 78758
Study site
Bardstown, Kentucky, 40004
Study site
Birmingham, Alabama, 35211
Study site
Charleston, South Carolina, 29403
Study site
Clovis, California, 93612
Study site
Columbus, Ohio, 43205
Study site
Fairfield, Connecticut, 06430
Study site
Fresno, California, 93270
Study site
Kalamazoo, Michigan, 49008
Study site
Lake Jackson, Texas, 77566
Study site
Las Vegas, Nevada, 89104
Study site
Little Rock, Arkansas, 72211
Study site
Longmont, Colorado, 80501
Study site
Louisville, Kentucky, 40207
Study site
Marietta, Georgia, 30062
Study site
Medford, Oregon, 97504
Study site
Mesa, Arizona, 85201
Study site
Montgomery, Alabama, 36116
Study site
Omaha, Nebraska, 68178
Study site
Owensboro, Kentucky, 42301
Study site
Ozark, Alabama, 36360
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Richland, Michigan, 49083
Study site
Ruston, Louisiana, 71270
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
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Scottsdale, Arizona, 85251
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Sellersville, Pennsylvania, 18960
Study site
Shreveport, Louisiana, 71105
Study site
Stone Mountain, Georgia, 30087
Study site
Vienna, Virginia, 22180
Study site
West Jordan, Utah, 84084
About this study
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
- Conditions
- Acute Otitis Media
- Being tested
- cefdinir (Omnicef), amoxicillin
- 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, ql2hr) for 5 days
amoxicillinDrug
oral suspension (45 mg/kg/day, q l2 hours) for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Not described Receives: Drug: amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
Measured: 9 days
Secondary outcomes (1)
Sustained Clinical Cure Rate
Measured: 28 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 startFeb 2003
- Primary completionApr 2003
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644943
- Sponsor's protocol ID
- M02-541
- Status last verified
- Mar 2008
- First submitted
- 21 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 the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00644943
- Acronym / sponsor ID
- M02-541
- Conditions
- Acute Otitis Media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Apr 2003 (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.
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Drug: amoxicillin |
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 acute otitis media <=1 week
- Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
- At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
- Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
- Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results
Key exclusion criteria (12 listed)
- Previous enrollment in this study.
- Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
- Presence of tympanostomy tubes or otitis externa at Evaluation 1.
- Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) 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, ql2hr) for 5 days | Drug | 1 |
| amoxicillinoral suspension (45 mg/kg/day, q l2 hours) for 10 days | Drug | 2 |
Primary outcome
Clinical Cure Rate
Time frame: 9 days
1 secondary outcome
Sustained Clinical Cure Rate
Time frame: 28 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.
32 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 amoxicillin in people with Acute Otitis Media, run by Abbott at 32 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 12 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 32 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 (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.