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

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ClinicalTrials.gov Identifier: NCT00645203
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Abbott

March 20, 2008
March 27, 2008
March 27, 2008
July 2002
April 2003   (Final data collection date for primary outcome measure)
  • Bacteriological Response [ Time Frame: 30 days ]
  • Clinical response [ Time Frame: 30 days ]
  • Change in the otoscopic findings [ Time Frame: 30 days ]
Same as current
No Changes Posted
  • Physical exam; Vital signs; Use of concomitant medications [ Time Frame: 59 days ]
  • Adverse events assessment [ Time Frame: 45 days with follow-up to a satisfactory conclusion ]
  • Laboratory evaluations [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Otitis Media
Drug: cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Other Name: ABT-198, Omnicef, cefdinir
1
Intervention: Drug: cefdinir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
Same as current
Not Provided
April 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 4 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Costa Rica,   Dominican Republic,   Guatemala,   Israel,   Panama,   United States
 
 
NCT00645203
M01-352
Not Provided
Not Provided
Not Provided
Angela M Nilius, Ph.D., Abbott
Abbott
Not Provided
Not Provided
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP