Acute Otitis Media Clinical Trial
Official title:
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT number | NCT00645112 |
Other study ID # | M03-630 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | March 22, 2008 |
Last updated | March 22, 2008 |
Start date | November 2003 |
Verified date | March 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
Status | Completed |
Enrollment | 357 |
Est. completion date | |
Est. primary completion date | January 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 6 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis, documented by medical history and physical examination, is AOM I 1 week. - Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the external auditory canal (following acute perforation of the tympanic membrane). - At least two (2) of the following signs are present in at least one ear: Full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5. - Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results. - Subject must be a suitable candidate for oral antibiotic therapy. Exclusion Criteria: - Previous enrollment in this study. - Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start. - Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens. - Presence of tympanostorny tubes or otitis externa at Evaluation 1. - Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1 or during the study. - Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration. - Concomitant infection that requires additional antimicrobial therapy. - Evidence of chronic, suppurative otitis media. - Evidence of perforation of the tympanic membrane > 24 hours. - Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media. - Immunocompromised subject (e.g., neutropenic subjects). - Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response. - Any expectation that treatment with probenecid will be expected during the study drug administration period. - Known significant renal or hepatic impairment. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure rate at Evaluation 2 | 9 days | No | |
Secondary | Sustained clinical cure rate at Evaluation 4 | 25 days | No |
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 |
NCT01941381 -
Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
|
||
Completed |
NCT02345447 -
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
|
Phase 3 | |
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 |
NCT00368823 -
A Trial of Point of Care Information in Ambulatory Pediatrics
|
Phase 3 | |
Completed |
NCT01272999 -
Impact of Prevnar 13 on Ear Infections in Children
|
||
Completed |
NCT01031082 -
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
|
N/A |