Otitis MediaPhase 2NCT00276042
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
A Phase 2 study testing Faropenem Medoxomil in people with Otitis Media, run by Replidyne at 2 sites in 2 countries.
Trial summary
The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Faropenem Medoxomil
- How many people
- 328 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to Jan 2007
- Phase
- Phase 2
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute Otis Media
Who cannot join
- Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media
The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem
Read the detailed description
The study will be conducted in infants and children with acute otitis media, 6 months to <7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.
- Conditions
- Otitis Media
- Being tested
- Faropenem Medoxomil
- Keywords
- AOM
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faropenem MedoxomilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate bacteriologic efficacy
Secondary outcomes (1)
To describe investigator assessment of clinical response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Replidyne
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roger M Echols, MD, Study director, Replidyne, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276042
- Sponsor's protocol ID
- REP-FAR-008
- Status last verified
- Feb 2008
- First submitted
- 10 Jan 2006
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00276042
- Acronym / sponsor ID
- REP-FAR-008
- Conditions
- Otitis Media
- Keywords
- AOM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- ReplidyneIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 12 Jan 2006 (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 study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem
Detailed description
The study will be conducted in infants and children with acute otitis media, 6 months to <7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Acute Otis Media
Key exclusion criteria (1 listed)
- Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
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 |
|---|---|---|
| Faropenem Medoxomil | Drug | – |
Primary outcome
To evaluate bacteriologic efficacy
1 secondary outcome
To describe investigator assessment of clinical response
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 8 Feb 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.
Roger M Echols, MD study director
Replidyne, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Faropenem Medoxomil in people with Otitis Media, run by Replidyne at 2 sites in 2 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 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Costa Rica, Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate bacteriologic efficacy. 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 8 Feb 2008.