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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00645203
• Collaborator: (none)
• Enrollment: 447
• Locations: 22
• Arm: 1
• Patients Per Site: 20.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Otitis Media	Drug: cefdinir	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 447 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Apr 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Other: 1	Drug: cefdinir; cefdinir oral suspension, 25 mg/kg once daily for 10 days; Other Names: ABT-198, Omnicef, cefdinir

Outcome Measures

Primary Outcome Measures

1. Bacteriological Response [30 days]

2. Clinical response [30 days]

3. Change in the otoscopic findings [30 days]

Secondary Outcome Measures

1. Physical exam; Vital signs; Use of concomitant medications [59 days]

2. Adverse events assessment [45 days with follow-up to a satisfactory conclusion]

3. Laboratory evaluations [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 4 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Scottsdale	Arizona	United States	85258
2		Clovis	California	United States	93611
3		Dinuba	California	United States	93618
4		Folsom	California	United States	95630
5		Denver	Colorado	United States	80218
6		Brooklyn	New York	United States	11203
7		Rochester	New York	United States	14618
8		Rochester	New York	United States	14620
9		Chapel Hill	North Carolina	United States	27514
10		Erie	Pennsylvania	United States	16508
11		Pittsburgh	Pennsylvania	United States	15213
12		Dallas	Texas	United States	75390-9035
13		Salt Lake City	Utah	United States	84113
14		Providencia	Santiago	Chile
15		Puente Alto, Santiago		Chile
16		La Uruca	San Jose	Costa Rica
17		San Jose		Costa Rica
18		Santo Domingo		Dominican Republic	ZC 02
19		Guatemala City		Guatemala	01011
20		Guatemala City		Guatemala
21		Beer Sheva		Israel	84101
22		Panama		Panama	4087

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00645203
• Other Study ID Numbers: M01-352
• First Posted: Mar 27, 2008
• Last Update Posted: Mar 27, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Otitis; Otitis Media; Cefdinir

Study Results

No Results Posted as of Mar 27, 2008