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Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00645203
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: cefdinir Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
Study Start Date : July 2002
Primary Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
Drug Information available for: Cefdinir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1 Drug: cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Other Name: ABT-198, Omnicef, cefdinir


Outcome Measures

Primary Outcome Measures :
  1. Bacteriological Response [ Time Frame: 30 days ]
  2. Clinical response [ Time Frame: 30 days ]
  3. Change in the otoscopic findings [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Physical exam; Vital signs; Use of concomitant medications [ Time Frame: 59 days ]
  2. Adverse events assessment [ Time Frame: 45 days with follow-up to a satisfactory conclusion ]
  3. Laboratory evaluations [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female children between 6 months and 4 years of age
  • Weight does not exceed 40 kg
  • Clinical diagnosis is acute otitis media
  • Have evidence of middle ear fluid
  • At risk for persistent or recurrent otitis media
  • Generally in good health

Exclusion Criteria:

  • Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
  • Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
  • Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
  • Concomitant infection, that requires additional antimicrobial therapy
  • Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645203


Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Clovis, California, United States, 93611
Dinuba, California, United States, 93618
Folsom, California, United States, 95630
United States, Colorado
Denver, Colorado, United States, 80218
United States, New York
Brooklyn, New York, United States, 11203
Rochester, New York, United States, 14618
Rochester, New York, United States, 14620
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Erie, Pennsylvania, United States, 16508
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Dallas, Texas, United States, 75390-9035
United States, Utah
Salt Lake City, Utah, United States, 84113
Chile
Providencia, Santiago, Chile
Puente Alto, Santiago, Chile
Costa Rica
La Uruca, San Jose, Costa Rica
San Jose, Costa Rica
Dominican Republic
Santo Domingo, Dominican Republic, ZC 02
Guatemala
Guatemala City, Guatemala, 01011
Guatemala City, Guatemala
Israel
Beer Sheva, Israel, 84101
Panama
Panama, Panama, 4087
Sponsors and Collaborators
Abbott
More Information

Responsible Party: Angela M Nilius, Ph.D., Abbott
ClinicalTrials.gov Identifier: NCT00645203     History of Changes
Other Study ID Numbers: M01-352
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents