NCT00645203

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for phase_2

Geographic Reach
7 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

9 months

First QC Date

March 20, 2008

Last Update Submit

March 20, 2008

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (3)

  • Bacteriological Response

    30 days

  • Clinical response

    30 days

  • Change in the otoscopic findings

    30 days

Secondary Outcomes (3)

  • Physical exam; Vital signs; Use of concomitant medications

    59 days

  • Adverse events assessment

    45 days with follow-up to a satisfactory conclusion

  • Laboratory evaluations

    30 days

Study Arms (1)

1

OTHER
Drug: cefdinir

Interventions

cefdinirDRUG

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

Also known as: ABT-198, Omnicef, cefdinir
1

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Clovis, California, 93611, United States

Location

Unknown Facility

Dinuba, California, 93618, United States

Location

Unknown Facility

Folsom, California, 95630, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Brooklyn, New York, 11203, United States

Location

Unknown Facility

Rochester, New York, 14618, United States

Location

Unknown Facility

Rochester, New York, 14620, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Erie, Pennsylvania, 16508, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Dallas, Texas, 75390-9035, United States

Location

Unknown Facility

Salt Lake City, Utah, 84113, United States

Location

Unknown Facility

Providencia, Santiago Metropolitan, Chile

Location

Unknown Facility

Puente Alto, Santiago, Chile

Location

Unknown Facility

Uruca, Provincia de San José, Costa Rica

Location

Unknown Facility

San José, Costa Rica

Location

Unknown Facility

Santo Domingo, ZC 02, Dominican Republic

Location

Unknown Facility

Guatemala City, 01011, Guatemala

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Beersheba, 84101, Israel

Location

Unknown Facility

Panama City, 4087, Panama

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Cefdinir

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 27, 2008

Study Start

July 1, 2002

Primary Completion

April 1, 2003

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

US(13)DO(1)GU(2)IL(1)PA(1)CL(2)CO(2)