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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645203
First received: March 20, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Acute Otitis Media
Drug: cefdinir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Bacteriological Response [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change in the otoscopic findings [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical exam; Vital signs; Use of concomitant medications [ Time Frame: 59 days ] [ Designated as safety issue: Yes ]
  • Adverse events assessment [ Time Frame: 45 days with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ]
  • Laboratory evaluations [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 447
Study Start Date: July 2002
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Other Name: ABT-198, Omnicef, cefdinir

  Eligibility

Ages Eligible for Study:   6 Months to 4 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Guatemala City, Guatemala, 01011
Israel
Beer Sheva, Israel, 84101
Panama
Panama, Panama, 4087
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Angela M Nilius, Ph.D., Abbott
ClinicalTrials.gov Identifier: NCT00645203     History of Changes
Other Study ID Numbers: M01-352
Study First Received: March 20, 2008
Last Updated: March 20, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014