Otitis MediaPhase 3NCT00051753
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
A Phase 3 study testing levofloxacin; amoxicillin/clavulanate in people with Otitis Media, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- levofloxacin; amoxicillin/clavulanate
- How many people
- 1,643 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to May 2005
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females, aged > or equal to 6 months to < 5 years
- Clinical signs and symptoms of otitis media including middle ear effusion and acute inflammation or acute purulent otorrhea
- At risk for difficult to treat Acute Otitis Media (AOM) is defined as having one of the following: recurrent Otitis Media (OM) as defined by 3 or more episodes in last 6 months or 4 or more episodes in past year or persistent OM as defined by evidence of AOM on 3rd day after starting any antimicrobial regimen
- Written consent/assent
- Have not participated in an experimental drug or medical device trial within 30 days prior to start of study.
Who cannot join
- History of hypersensitivity or serious reaction to any quinolone
- Tympanostomy tube in the affected ear
- Requires use of systemic antibiotic other than study drug
- Has a serious bacterial infection in addition to AOM that may interfere with assessment of their clinical response
- Diagnosed with bacterial meningitis
- Abnormal renal function defined as serum creatinine >0.5 mg/dL in infants 6 months or older and 0.8 mg/dL in children between 1 and 5 years of age
Show all 15Show fewer
- History or presence of arthropathy or periarticular disease or any other musculoskeletal signs or symptoms that may confound a future safety exam of MS events
- Has a high probability of death during the study
- Poorly controlled seizure disorder or at risk for seizures
- HIV infection requiring pneumocystis carinii pneumonia prophylaxis
- Chronic use of corticosteroids 2mg/kg or more or 20mg/day for 14 or more days
- Amoxicillin/clavulanate (90 mg/kg/day) use within 3 days before the first dose of the study drug
- Previous participation in this protocol or another levofloxacin clinical study
- Employees of the investigator or study center with direct involvement in the study
- Family members are also excluded
About this study
Official title: A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.
Read the detailed description
This is a randomized, active-comparator, multicenter study consisting of 3 phases: a Pretreatment (Screening) Phase, a Treatment Phase, and a Posttreatment Phase. Subject eligibility will be determined at the screening visit based on signs and symptoms of acute otitis media (e.g., middle ear effusion, acute inflammation, acute purulent otorrhea) and criteria for recurrent and/or persistent acute otitis media. Eligible subjects will be randomized and drug will be dispensed by a study coordinator who will instruct parents and the subject about the importance of not revealing the assigned therapy to the subject's evaluator. Each subject will have an evaluator who will remain blinded to the subject's therapy throughout the study. Clinical assessments performed by a blinded evaluator at several time points throughout the study will be used to evaluate efficacy. Safety will be evaluated throughout the study by assessment of adverse events and changes in physical examinations (including musculoskeletal examination with evaluation of joints), vital signs, and clinical laboratory findings. Supplementary safety evaluations for musculoskeletal adverse events will be performed throughout the study. All subjects who enroll in this study and take at least 1 dose of levofloxacin or amoxicillin/clavulanate will be eligible to rollover into a long-term surveillance study primarily focused on the musculoskeletal system. The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media. Either levofloxacin 10 mg/kg twice daily for 10 days (maximum daily dose of 500 mg) or amoxicillin/clavulanate (14:1) 45 mg amoxicillin/kg twice daily for 10 days (maximum daily dose of 3600 mg amoxicillin). Both study drugs will be given orally as a liquid suspension formulation
- Conditions
- Otitis Media
- Being tested
- levofloxacin; amoxicillin/clavulanate
- Keywords
- Otitis Media, Acute Otitis Media, ear infection, levofloxacin, amoxicillin, clavulanate
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin; amoxicillin/clavulanateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose).
Secondary outcomes (1)
Clinical success (cured and improved versus failed) rate at Visit 3 (2 to 5 days after the last dose) and Visit 4 (10 to 17 days after the last dose); clinical cure rate at Visit 4 (10 to 17 days after the last dose); safety evaluations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2003 (estimated)
- Study startNov 2002
- Study completionMay 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051753
- Sponsor's protocol ID
- CR004168
- Status last verified
- Jan 2011
- First submitted
- 16 Jan 2003
- Last updated
- 10 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00051753
- Acronym / sponsor ID
- CR004168
- Conditions
- Otitis Media
- Keywords
- Otitis Media, Acute Otitis Media, ear infection, levofloxacin, amoxicillin, clavulanate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,643 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- May 2005 (actual)
- First posted
- 17 Jan 2003 (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 purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.
Detailed description
This is a randomized, active-comparator, multicenter study consisting of 3 phases: a Pretreatment (Screening) Phase, a Treatment Phase, and a Posttreatment Phase. Subject eligibility will be determined at the screening visit based on signs and symptoms of acute otitis media (e.g., middle ear effusion, acute inflammation, acute purulent otorrhea) and criteria for recurrent and/or persistent acute otitis media. Eligible subjects will be randomized and drug will be dispensed by a study coordinator who will instruct parents and the subject about the importance of not revealing the assigned therapy to the subject's evaluator. Each subject will have an evaluator who will remain blinded to the subject's therapy throughout the study. Clinical assessments performed by a blinded evaluator at several time points throughout the study will be used to evaluate efficacy. Safety will be evaluated throughout the study by assessment of adverse events and changes in physical examinations (including musculoskeletal examination with evaluation of joints), vital signs, and clinical laboratory findings. Supplementary safety evaluations for musculoskeletal adverse events will be performed throughout the study. All subjects who enroll in this study and take at least 1 dose of levofloxacin or amoxicillin/clavulanate will be eligible to rollover into a long-term surveillance study primarily focused on the musculoskeletal system. The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media. Either levofloxacin 10 mg/kg twice daily for 10 days (maximum daily dose of 500 mg) or amoxicillin/clavulanate (14:1) 45 mg amoxicillin/kg twice daily for 10 days (maximum daily dose of 3600 mg amoxicillin). Both study drugs will be given orally as a liquid suspension formulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females, aged > or equal to 6 months to < 5 years
- Clinical signs and symptoms of otitis media including middle ear effusion and acute inflammation or acute purulent otorrhea
- At risk for difficult to treat Acute Otitis Media (AOM) is defined as having one of the following: recurrent Otitis Media (OM) as defined by 3 or more episodes in last 6 months or 4 or more episodes in past year or persistent OM as defined by evidence of AOM on 3rd day after starting any antimicrobial regimen
- Written consent/assent
- Have not participated in an experimental drug or medical device trial within 30 days prior to start of study.
Key exclusion criteria (15 listed)
- History of hypersensitivity or serious reaction to any quinolone
- Tympanostomy tube in the affected ear
- Requires use of systemic antibiotic other than study drug
- Has a serious bacterial infection in addition to AOM that may interfere with assessment of their clinical response
- Diagnosed with bacterial meningitis
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 |
|---|---|---|
| levofloxacin; amoxicillin/clavulanate | Drug | – |
Primary outcome
Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose).
1 secondary outcome
Clinical success (cured and improved versus failed) rate at Visit 3 (2 to 5 days after the last dose) and Visit 4 (10 to 17 days after the last dose); clinical cure rate at Visit 4 (10 to 17 days after the last dose); safety evaluations
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 10 Jan 2011.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levofloxacin; amoxicillin/clavulanate in people with Otitis Media, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 15 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 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 (cured versus not cured) at Visit 3 (2 to 5 days after last dose).. 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 10 Jan 2011.