Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00051753

Purpose

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.

Condition	Intervention	Phase
Otitis Media	Drug: levofloxacin; amoxicillin/clavulanate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose).

Secondary Outcome Measures:

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

Enrollment:	1643
Study Start Date:	November 2002
Study Completion Date:	May 2005

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

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051753

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00051753 History of Changes
Other Study ID Numbers:	CR004168
Study First Received:	January 16, 2003
Last Updated:	January 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Otitis Media
Acute Otitis Media
ear infection

levofloxacin
amoxicillin
clavulanate

Additional relevant MeSH terms:

Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Ofloxacin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012