Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00645203
Other study ID # M01-352
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 20, 2008
Last updated March 20, 2008
Start date July 2002

Study information

Verified date March 2008
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 447
Est. completion date
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 4 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Chile,  Costa Rica,  Dominican Republic,  Guatemala,  Israel,  Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bacteriological Response 30 days No
Primary Clinical response 30 days No
Primary Change in the otoscopic findings 30 days No
Secondary Physical exam; Vital signs; Use of concomitant medications 59 days Yes
Secondary Adverse events assessment 45 days with follow-up to a satisfactory conclusion Yes
Secondary Laboratory evaluations 30 days Yes
See also
  Status Clinical Trial Phase
Completed NCT02092454 - Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media Phase 2
Completed NCT01202578 - Evaluation of the Tympanostomy Tube Delivery System Phase 2/Phase 3
Withdrawn NCT00502450 - Is There Hearing Loss After Acute Mastoiditis N/A
Completed NCT04296448 - Evaluation of Cellphone Based Otoscopy in Pediatric Patients N/A
Terminated NCT05651633 - Analgesic Ear Drops for Children With Acute Otitis Media Phase 3
Completed NCT02345447 - Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence Phase 3
Completed NCT01941381 - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
Recruiting NCT01214538 - Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children N/A
Completed NCT03614117 - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) N/A
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Completed NCT02918773 - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) N/A
Completed NCT02567747 - Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Completed NCT02935374 - Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children Phase 4
Completed NCT02567825 - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media N/A
Completed NCT02037893 - Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media Phase 2
Completed NCT00578773 - A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea Phase 2
Completed NCT00377260 - Acute Otitis Media (AOM) Therapy Trial in Young Children Phase 4
Completed NCT00645112 - A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media Phase 4
Completed NCT00368823 - A Trial of Point of Care Information in Ambulatory Pediatrics Phase 3
Completed NCT01272999 - Impact of Prevnar 13 on Ear Infections in Children