A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Acute Otitis Media Clinical Trial

Official title:

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644943
• Other study ID #: M02-541
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2008
• Last updated: March 21, 2008
• Start date: February 2003

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

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis, documented by medical history and physical examination, is acute otitis media <=1 week

• Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).

• At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.

• Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.

• Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results

Exclusion Criteria:

• Previous enrollment in this study.

• Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.

• Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.

• Presence of tympanostomy tubes or otitis externa at Evaluation 1.

• Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) prior to Evaluation 1 or during the study.

• Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.

• Concomitant infection, that requires additional antimicrobial therapy.

• Evidence of chronic, suppurative otitis media.

• Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.

• Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.

• Known, severe renal impairment (i.e., creatinine clearance < 30 mUmid1.73 m2).

• History of Augmentin-associated cholestatic jaundicehepatic dysfunction.

Study Design

Allocation: Randomized, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
• amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate		9 days	No
Secondary	Sustained Clinical Cure Rate		28 days	No