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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00645203

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 II Phase III

MedlinePlus related topics: Ear Infections

Drug Information available for: Cefdinir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645203

Show 22 Study Locations

Sponsors and Collaborators

Abbott

More Information

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

Study placed in the following topic categories:

Cephalosporins
Otorhinolaryngologic Diseases
Cefdinir
Otitis

Cefixime
Otitis Media
Ear Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009