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OpenTrials
Completed

NCT Number: NCT00645203

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat 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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Providencia, Santiago Metropolitan, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cefdinir

Drug

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

Other names: ABT-198, Omnicef, cefdinir

Primary outcomes

  1. Bacteriological Response

    Time frame: 30 days

  2. Clinical response

    Time frame: 30 days

  3. Change in the otoscopic findings

    Time frame: 30 days

Secondary outcomes

  1. Physical exam; Vital signs; Use of concomitant medications

    Time frame: 59 days

  2. Adverse events assessment

    Time frame: 45 days with follow-up to a satisfactory conclusion

  3. Laboratory evaluations

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
First posted
Mar 27, 2008
Registry last updated
Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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