Acute Otitis MediaPhase 2/3NCT00645203
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
A Phase 2/3 study testing cefdinir in people with Acute Otitis Media, run by Abbott at 22 sites in 7 countries.
Trial summary
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- cefdinir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Jul 2002to Apr 2003
- Phase
- Phase 2/3
- 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 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children between 6 months and 4 years of age
- Weight does not exceed 40 kg
- Clinical diagnosis is acute otitis media
- Have evidence of middle ear fluid
- At risk for persistent or recurrent otitis media
- Generally in good health
Who cannot join
- Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
- Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
- Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
- Concomitant infection, that requires additional antimicrobial therapy
- Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States13 sites
Study site
Brooklyn, New York, 11203
Study site
Chapel Hill, North Carolina, 27514
Study site
Clovis, California, 93611
Study site
Dallas, Texas, 75390-9035
Study site
Denver, Colorado, 80218
Study site
Dinuba, California, 93618
Study site
Erie, Pennsylvania, 16508
Study site
Folsom, California, 95630
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Rochester, New York, 14618
Study site
Rochester, New York, 14620
Study site
Salt Lake City, Utah, 84113
Study site
Scottsdale, Arizona, 85258
Chile2 sites
Study site
Providencia, Santiago Metropolitan
Study site
Puente Alto, Santiago
Costa Rica2 sites
Study site
San José
Study site
Uruca, Provincia de San José
About this study
Official title: An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
- Conditions
- Acute Otitis Media
- Being tested
- cefdinir
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefdinirDrug
Also called ABT-198, Omnicef, cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: cefdinir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological Response
Measured: 30 days
Clinical response
Measured: 30 days
Change in the otoscopic findings
Measured: 30 days
Secondary outcomes (3)
Physical exam; Vital signs; Use of concomitant medications
Measured: 59 days
Adverse events assessment
Measured: 45 days with follow-up to a satisfactory conclusion
Laboratory evaluations
Measured: 30 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 startJul 2002
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645203
- Sponsor's protocol ID
- M01-352
- Status last verified
- Mar 2008
- First submitted
- 20 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
- An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00645203
- Acronym / sponsor ID
- M01-352
- Conditions
- Acute Otitis Media
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- 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.
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: cefdinir |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female children between 6 months and 4 years of age
- Weight does not exceed 40 kg
- Clinical diagnosis is acute otitis media
- Have evidence of middle ear fluid
- At risk for persistent or recurrent otitis media
Key exclusion criteria (5 listed)
- Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
- Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
- Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
- Concomitant infection, that requires additional antimicrobial therapy
- Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
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 |
|---|---|---|
| cefdinirAlso: ABT-198, Omnicef, cefdinircefdinir oral suspension, 25 mg/kg once daily for 10 days | Drug | 1 |
Primary outcome
Bacteriological Response
Time frame: 30 days
Clinical response
Time frame: 30 days
Change in the otoscopic findings
Time frame: 30 days
3 secondary outcomes
Physical exam; Vital signs; Use of concomitant medications
Time frame: 59 days
Adverse events assessment
Time frame: 45 days with follow-up to a satisfactory conclusion
Laboratory evaluations
Time frame: 30 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.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cefdinir in people with Acute Otitis Media, run by Abbott at 22 sites in 7 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 6 inclusion and 5 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 22 sites in United States, Chile, Costa Rica, Guatemala, Dominican Republic and 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Bacteriological Response (time frame: 30 days). The study lists 3 primary outcomes in all. 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.