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	Treatment or Intervention	Phase
Otitis Media	Drug: Levofloxacin  Drug: Augmentin ES-600	Phase III

Further Study Details: 

Expected Total Enrollment:  1650

Ages Eligible for Study:  6 Months   -   5 Years,  Genders Eligible for Study:  Both

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 amy 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.
• 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.

Alabama
      Edward Goldblatt, M.D., Alabaster,  Alabama,  35007,  United States; Terminated
      Clinical Research Consultants, Inc., Hoover,  Alabama,  35216,  United States; Terminated
      University of Alabama at Birmingham, Birmingham,  Alabama,  35233,  United States; Terminated
Arizona
      Kevin Concannon, MD, Tucson,  Arizona,  85741,  United States; Recruiting
California
      Center for Clinical Trials, LLC, Paramount,  California,  90723,  United States; Recruiting
      Madera Family Medical Group, Madera,  California,  93637,  United States; Recruiting
      Peninsula Research Assoc., Inc., Rolling Hills Est,  California,  90274,  United States; Recruiting
      Wignes Warren, MD, West Covina,  California,  91790,  United States; Recruiting
Delaware
      J. Jordan Storlazzi, Jr., Wilmington,  Delaware,  19810,  United States; Recruiting
Florida
      Mobeen Rathore, MD, Jacksonville,  Florida,  32209,  United States; Recruiting
Georgia
      Columbus Regional Healthcare System, Columbus,  Georgia,  31902,  United States; Terminated
      River Birch Research Alliance, Blue Ridge,  Georgia,  30513,  United States; Recruiting
      Willis Memorial Hospital, Augusta,  Georgia,  30909,  United States; Terminated
Hawaii
      Hawaii Pacific Health Research Institute, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      Kristi Lundblad, MD, Park Ridge,  Illinois,  60068,  United States; Recruiting
      Mount Sinai Hospital, Chicago,  Illinois,  60608,  United States; Recruiting
Iowa
      John Sutherland, MD, Waterloo,  Iowa,  50702,  United States; Terminated
Kentucky
      Commonwealth Ear, Nose & Throat, Louisville,  Kentucky,  40207,  United States; Recruiting
      Christopher Harrison, MD, Louisville,  Kentucky,  40202,  United States; Recruiting
      Kentucky Pediatric/Adult Research, Bardstown,  Kentucky,  40004,  United States; Recruiting
Louisiana
      LSU Medical Center, Shreveport,  Louisiana,  71130,  United States; Recruiting
      Eduardo Hernandez, MD, Slidell,  Louisiana,  70461,  United States; Recruiting
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Nebraska
      Creighton University, Omaha,  Nebraska,  68131,  United States; Recruiting
New York
      Regional Clinical Research, Johnson City,  New York,  13790,  United States; Recruiting
      Winthrop Pediatric Infectious Diseases, Mineola,  New York,  11501,  United States; Completed
      New York Weill Cornell Center, New York,  New York,  10022,  United States; Recruiting
North Carolina
      Emmanuel Walter, MD, Durham,  North Carolina,  27704,  United States; Recruiting
Ohio
      Rainbow Babies & Children's Hospital, Cleveland,  Ohio,  44106,  United States; Recruiting
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308-1062,  United States; Recruiting
      Phillip Walson, MD, Cincinnati,  Ohio,  45229-30339,  United States; Recruiting
Pennsylvania
      Keystone Clinical Solutions, Altoona,  Pennsylvania,  16602,  United States; Recruiting
      Primary Physician's Research, Inc., Pittsburgh,  Pennsylvania,  15241,  United States; Recruiting
      Peter Lane, MD, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      Primary Physicians Research, Inc., Pittsburgh,  Pennsylvania,  15241,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Integrity Clinical Research (Attn: Kristi Johnson), Milan,  Tennessee,  38358,  United States; Terminated
Texas
      South Texas Applied Research, Corpus Christi,  Texas,  78411,  United States; Recruiting
      Texas Children's Hospital, Houston,  Texas,  77030,  United States; Recruiting
Utah
      American Fork Hospital, American Fork,  Utah,  84003,  United States; Recruiting
      Kelly E. Stoker, MD, Salt Lake City,  Utah,  84102,  United States; Recruiting
Virginia
      Inova Fairfax Hospital, Burke,  Virginia,  22015,  United States; Recruiting
      Advanced Pediatrics, Vienna,  Virginia,  22124,  United States; Recruiting
Argentina, Buenos Aires
      Victor Israele, MD, San Isidro,  Buenos Aires,  1642,  Argentina; Recruiting
      Abel Jasovich, MD, Capital Federal,  Buenos Aires,  1425,  Argentina; Recruiting
      PAIDEIA, Salguero,  Buenos Aires,  1425DEM,  Argentina; Recruiting
      Juan B. Justo 4332, Capital Federal,  Buenos Aires,  1416,  Argentina; Recruiting
      Carota Russ, MD, Gaona,  Buenos Aires,  1416,  Argentina; Recruiting
Brazil, Curitiba-PR-CEP
      Hospital Nossa Sra das Gracas, Setor Estar Medico,  Curitiba-PR-CEP,  80810-050,  Brazil; Completed
      Hospital de Clinicas do Parana, Otarrino - 5 andar anexo B,  Curitiba-PR-CEP,  80060-900,  Brazil; Completed
      Hospital de Clinicas - UFPR, Infectologia - 3 andar,  Curitiba-PR-CEP,  80060-900,  Brazil; Completed
Brazil, Jacana-Sao Paulo-SP-CEP
      Hospital Sao Luiz Gonzaga, Depto de Pediatria,  Jacana-Sao Paulo-SP-CEP,  02276-140,  Brazil; Completed
Brazil, Porto Alegre-RS-CEP
      Hospital de Clinicas de Porto Alegre, Depto de Otorrinolaringologia,  Porto Alegre-RS-CEP,  90035-003,  Brazil; Terminated
Brazil, Ribeirao Preto-Sao Paulo-SP-CEP
      Hospital Santa Lidia, Servico de Otorrino,  Ribeirao Preto-Sao Paulo-SP-CEP,  14085070,  Brazil; Completed
Brazil, Sao Paulo-SP-CDP
      Hospital Israelita Albert Einstein, Paraisopolis,  Sao Paulo-SP-CDP,  05663-020,  Brazil; Completed
Brazil, Sao Paulo-SP-CEP
      Hospital de Clinicas FMUSP, Pronto Socorro,  Sao Paulo-SP-CEP,  05409-003,  Brazil; Completed
Costa Rica, San Jose
      Neeman-Instituto Costarricense de Investigaciones Clinicas, Los Arboles,  San Jose,  Costa Rica; Completed
Mexico, Jalisco
      Hospital Universitario Angel Leano, Zapopan,  Jalisco,  45200,  Mexico; Terminated
Mexico, Puebla
      Alejandro Flores-Nunez, MD, Atlixa,  Puebla,  72190,  Mexico; Terminated
Mexico, Towca
      Felipe Oliveros Lozano, MD, Vialidad A. del majo Esqv.,  Towca,  50010,  Mexico; Terminated

Study ID Numbers:  LOFBO-OTMD-002
Record last reviewed:  January 2005
Last Updated:  January 12, 2005
Record first received:  January 16, 2003
ClinicalTrials.gov Identifier:  NCT00051753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08