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

Acute Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645203
• Other study ID #: M01-352
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 20, 2008
• Last updated: March 20, 2008
• Start date: July 2002

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 4 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Chile,  Costa Rica,  Dominican Republic,  Guatemala,  Israel,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriological Response		30 days	No
Primary	Clinical response		30 days	No
Primary	Change in the otoscopic findings		30 days	No
Secondary	Physical exam; Vital signs; Use of concomitant medications		59 days	Yes
Secondary	Adverse events assessment		45 days with follow-up to a satisfactory conclusion	Yes
Secondary	Laboratory evaluations		30 days	Yes