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

March 20, 2008 updated by: Abbott

An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Puente Alto, Santiago, Chile
    • Santiago
      • Providencia, Santiago, Chile
  • Costa Rica
      • San Jose, Costa Rica
    • San Jose
      • La Uruca, San Jose, Costa Rica
  • Dominican Republic
      • Santo Domingo, Dominican Republic, ZC 02
  • Guatemala
      • Guatemala City, Guatemala
      • Guatemala City, Guatemala, 01011
  • Israel
      • Beer Sheva, Israel, 84101
  • Panama
      • Panama, Panama, 4087
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • California
      • Clovis, California, United States, 93611
      • Dinuba, California, United States, 93618
      • Folsom, California, United States, 95630
    • Colorado
      • Denver, Colorado, United States, 80218
    • New York
      • Brooklyn, New York, United States, 11203
      • Rochester, New York, United States, 14618
      • Rochester, New York, United States, 14620
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16508
      • Pittsburgh, Pennsylvania, United States, 15213
    • Texas
      • Dallas, Texas, United States, 75390-9035
    • Utah
      • Salt Lake City, Utah, United States, 84113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacteriological Response
Time Frame: 30 days
30 days
Clinical response
Time Frame: 30 days
30 days
Change in the otoscopic findings
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical exam; Vital signs; Use of concomitant medications
Time Frame: 59 days
59 days
Adverse events assessment
Time Frame: 45 days with follow-up to a satisfactory conclusion
45 days with follow-up to a satisfactory conclusion
Laboratory evaluations
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 20, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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