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

Primary Purpose

Acute Otitis Media

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cefdinir
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Media

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Bacteriological Response
Clinical response
Change in the otoscopic findings

Secondary Outcome Measures

Physical exam; Vital signs; Use of concomitant medications
Adverse events assessment
Laboratory evaluations

Full Information

First Posted
March 20, 2008
Last Updated
March 20, 2008
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00645203
Brief Title
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
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 Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
cefdinir
Other Intervention Name(s)
ABT-198, Omnicef, cefdinir
Intervention Description
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Primary Outcome Measure Information:
Title
Bacteriological Response
Time Frame
30 days
Title
Clinical response
Time Frame
30 days
Title
Change in the otoscopic findings
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Physical exam; Vital signs; Use of concomitant medications
Time Frame
59 days
Title
Adverse events assessment
Time Frame
45 days with follow-up to a satisfactory conclusion
Title
Laboratory evaluations
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
City
Folsom
State/Province
California
ZIP/Postal Code
95630
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9035
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
City
Providencia
State/Province
Santiago
Country
Chile
City
Puente Alto, Santiago
Country
Chile
City
La Uruca
State/Province
San Jose
Country
Costa Rica
City
San Jose
Country
Costa Rica
City
Santo Domingo
ZIP/Postal Code
ZC 02
Country
Dominican Republic
City
Guatemala City
ZIP/Postal Code
01011
Country
Guatemala
City
Guatemala City
Country
Guatemala
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
City
Panama
ZIP/Postal Code
4087
Country
Panama

12. IPD Sharing Statement

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

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