NCT00051753

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,643

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

First QC Date

January 16, 2003

Last Update Submit

January 7, 2011

Conditions

Otitis Media

Keywords

Otitis MediaAcute Otitis Mediaear infectionlevofloxacinamoxicillinclavulanate

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

levofloxacin; amoxicillin/clavulanateDRUG

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis MediaOtitis

Interventions

LevofloxacinAmoxicillinClavulanic Acid

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsClavulanic Acids

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2003

First Posted

January 17, 2003

Study Start

November 1, 2002

Study Completion

May 1, 2005

Last Updated

January 10, 2011

Record last verified: 2011-01