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Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Clinical research trials and Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media. Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media  Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
For Condition: Otitis Media
Status: Recruiting
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Months/5 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 1650
Location and Contact Information:
Kentucky Pediatric/Adult Research *Recruiting*
Bardstown, Kentucky, 40004
United States
Recruiting James Hedrick 502-349-1569
Columbus Regional Healthcare System *Terminated*
Columbus, Georgia, 31902
United States
Terminated
Abel Jasovich, MD *Recruiting*
Capital Federal, Buenos Aires, 1425
Argentina
Recruiting Abel Jasovich 011-54-4739-9359
Hawaii Pacific Health Research Institute *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Ronald Hino 808-487-2477
University of Alabama at Birmingham *Terminated*
Birmingham, Alabama, 35233
United States
Terminated
Hospital Sao Luiz Gonzaga *Recruiting*
Depto de Pediatria, Jacana-Sao Paulo-SP-CEP, 02276-140
Brazil
Recruiting Ana Magni 011-55-11-69825212
Victor Israele, MD *Recruiting*
San Isidro, Buenos Aires, 1642
Argentina
Recruiting Victor Israele 011-54-11-4706-0029
Peter Lane, MD *Recruiting*
Philadelphia, Pennsylvania, 19141
United States
Recruiting Antoinette Mangione 215-456-6491
Regional Clinical Research *Recruiting*
Johnson City, New York, 13790
United States
Recruiting Christopher Demtrak 607-754-4081
Emmanuel Walter, MD *Recruiting*
Durham, North Carolina, 27704
United States
Recruiting Emmanuel Walter 919-620-5374
Alejandro Flores-Nunez, MD *Terminated*
Atlixa, Puebla, 72190
Mexico
Terminated
Hospital de Clinicas de Porto Alegre *Terminated*
Depto de Otorrinolaringologia, Porto Alegre-RS-CEP, 90035-003
Brazil
Terminated
Edward Goldblatt, M.D. *Terminated*
Alabaster, Alabama, 35007
United States
Terminated
Felipe Oliveros Lozano, MD *Terminated*
Vialidad A. del majo Esqv., Towca, 50010
Mexico
Terminated
J. Jordan Storlazzi, Jr. *Recruiting*
Wilmington, Delaware, 19810
United States
Recruiting J. Storlazzi 302-478-1975
Clinical Research Consultants, Inc. *Terminated*
Hoover, Alabama, 35216
United States
Terminated
Willis Memorial Hospital *Terminated*
Augusta, Georgia, 30909
United States
Terminated
Christopher Harrison, MD *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Christopher Harrison 502-852-3774
Phillip Walson, MD *Recruiting*
Cincinnati, Ohio, 45229-30339
United States
Recruiting Phillip Walson 513-636-5311
Carota Russ, MD *Recruiting*
Gaona, Buenos Aires, 1416
Argentina
Recruiting Carlota Russ 011-54-11-4586-8819
South Texas Applied Research *Recruiting*
Corpus Christi, Texas, 78411
United States
Recruiting E. Cortes 361-814-2223
Center for Clinical Trials, LLC *Recruiting*
Paramount, California, 90723
United States
Recruiting Liberation DeLeon 562-633-5101
Hospital de Clinicas do Parana *Recruiting*
Otarrino - 5 andar anexo B, Curitiba-PR-CEP, 80060-900
Brazil
Recruiting Marcos Mocellin 011-55-41-3141521
Peninsula Research Assoc., Inc. *Recruiting*
Rolling Hills, California, 90274
United States
Recruiting Lawrence Sher 310-265-1623
Winthrop Pediatric Infectious Diseases *Recruiting*
Mineola, New York, 11501
United States
Recruiting Leonard Krilov 516-663-9570
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Paul Darden 843-953-8512
Wignes Warren, MD *Recruiting*
West Covina, California, 91790
United States
Recruiting Wignes Warren 626-960-4942
Hospital Santa Lidia *Recruiting*
Servico de Otorrino, Ribeirao Preto-Sao Paulo-SP-CEP, 14085070
Brazil
Recruiting Marcelo Piza 011-55-16-610-6515
Neeman-Instituto Costarricense de Investigaciones Clinicas *Completed*
Los Arboles, San Jose,
Costa Rica
Completed
Children's Hospital Medical Center of Akron *Recruiting*
Akron, Ohio, 44308-1062
United States
Recruiting Blaise Congeni 330-543-8395
Advanced Pediatrics *Recruiting*
Vienna, Virginia, 22124
United States
Recruiting Richard Schwartz 703-938-5555
PAIDEIA *Recruiting*
Salguero, Buenos Aires, 1425DEM
Argentina
Recruiting Juan Alejandro Lanoel 011-54-11-4806-1350
LSU Medical Center *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Joseph Bocchini 318-675-6076
New York Weill Cornell Center *Recruiting*
New York City, New York, 10022
United States
Recruiting Joseph Stavola 212-746-3326
Mount Sinai Hospital *Recruiting*
Chicago, Illinois, 60608
United States
Recruiting Leslie Zun 773-257-6957
Juan B. Justo 4332 *Recruiting*
Capital Federal, Buenos Aires, 1416
Argentina
Recruiting Oscar Ruvinsky 011-54-11-4581-6304
Primary Physicians Research, Inc. *Recruiting*
Pittsburgh, Pennsylvania, 15241
United States
Recruiting Keith Reisinger 412-257-4461
Keystone Clinical Solutions *Recruiting*
Altoona, Pennsylvania, 16602
United States
Recruiting Lawrence Adams 814-940-1212
River Birch Research Alliance *Recruiting*
Blue Ridge, Georgia, 30513
United States
Recruiting Raymond Tidman 706-632-4404
Kevin Concannon, MD *Recruiting*
Tucson, Arizona, 85741
United States
Recruiting Kevin Concannon 520-544-7650
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Mark Ward 832-824-5459
Commonwealth Ear, Nose & Throat *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Keith Forwith 502-893-0159
Eduardo Hernandez, MD *Recruiting*
Slidell, Louisiana, 70461
United States
Recruiting Eduardo Hernandez 985-781-7337
Madera Family Medical Group *Recruiting*
Madera, California, 93637
United States
Recruiting Aftab Naz 559-673-3000
Hospital Israelita Albert Einstein *Recruiting*
Paraisopolis, Sao Paulo-SP-CDP, 05663-020
Brazil
Recruiting Erica Santos 011-55-11-3747-1545
Hospital de Clinicas FMUSP *Recruiting*
Pronto Socorro, Sao Paulo-SP-CEP, 05409-003
Brazil
Recruiting Claudio Schvartsman 011-55-11-30698703
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Basim Asmar 313-745-5863
Primary Physician's Research, Inc. *Recruiting*
Pittsburgh, Pennsylvania, 15241
United States
Recruiting Mark Blatter 412-257-4461
Mobeen Rathore, MD *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Mobeen Rathore 904-244-3051
American Fork Hospital *Recruiting*
American Fork, Utah, 84003
United States
Recruiting Manford Gooch 801-272-9234
Kristi Lundblad, MD *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting Kristi Lundblad 847-723-8409
Creighton University *Recruiting*
Omaha, Nebraska, 68131
United States
Recruiting Jose Romero 402-280-1230
Hospital Universitario Angel Leano *Terminated*
Zapopan, Jalisco, 45200
Mexico
Terminated
Rainbow Babies & Children's Hospital *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Jeffrey Blumer 216-844-3310
Inova Fairfax Hospital *Recruiting*
Burke, Virginia, 22015
United States
Recruiting Frederic Garner 703-426-0800
Hospital de Clinicas - UFPR *Recruiting*
Infectologia - 3 andar, Curitiba-PR-CEP, 80060-900
Brazil
Recruiting Nelson Rosario 011-55-41-91015181
Kelly E. Stoker, MD *Recruiting*
Salt Lake City, Utah, 84102
United States
Recruiting Kelly Stoker 801-355-4126
Hospital Nossa Sra das Gracas *Recruiting*
Setor Estar Medico, Curitiba-PR-CEP, 80810-050
Brazil
Recruiting Clovis Da Cunha 011-55-41-3390959
Integrity Clinical Research (Attn: Kristi Johnson) *Terminated*
Milan, Tennessee, 38358
United States
Terminated
John Sutherland, MD *Terminated*
Waterloo, Iowa, 50702
United States
Terminated
Additional Information:
Study ID Numbers: LOFBO-OTMD-002;
Study Start Date: November 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051753
Other Otitis Media Studies:
1. Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
2. Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
3. Acute Otitis Media: Adjuvant Therapy to Improve Outcome
4. Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media
Related Studies:
Other Otitis Media Clinical Trials
Other Curitiba-PR-CEP Clinical Trials
Other Infectologia - 3 andar Clinical Trials
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
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