Status:
TERMINATED
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
Lead Sponsor:
Alejandro Hoberman
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-23 years
Phase:
PHASE2
Brief Summary
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfacto...
Detailed Description
Eligible subjects will be randomized at the enrollment visit and will have a telephone call in the course of therapy, and a subsequent visit at the end of therapy. Thereafter, they will be followed th...
Eligibility Criteria
Inclusion
- Aged 6 through 23 months
- Have evidence of AOM defined as:
- recent (within 48 hours) onset of signs and symptoms as described in the Acute Otitis Media - Severity of Symptoms (AOM-SOS) Scale AND a score of ≥3 at the time of enrollment on the AOM-SOS scale
- middle ear effusion evidenced by the presence of at least 2 of the following:
- decreased or absent mobility of the tympanic membrane
- yellow or white discoloration of the tympanic membrane
- opacification of the tympanic membrane
- AND
- acute inflammation evidenced by one of the following:
- 1+ bulging of the tympanic membrane with either intense erythema or otalgia
- 2+ or 3+ bulging of the tympanic membrane
- Has received at least 2 doses of pneumococcal conjugate vaccine
- Parent has provided informed consent
Exclusion
- Toxic appearance \[capillary refill \>3 seconds, systolic blood pressure \<60 mm Hg\];
- Inpatient hospitalization
- Clinical or anatomical characteristics that might obscure response to treatment (tympanostomy tubes in place, cleft palate, or Down syndrome)
- Sensorineural hearing loss (unilateral or bilateral)
- Serious underlying systemic problems that might obscure response to infection (cystic fibrosis, neoplasm, juvenile diabetes)
- Concomitant infection that would preclude evaluation of the response of the child's AOM to study product (pneumonia, periorbital cellulitis)
- Acute wheezing exacerbation which may require treatment with systemic corticosteroids
- Known renal or hepatic dysfunction or insufficiency
- History of amoxicillin-clavulanate-associated cholestatic jaundice
- Immune dysfunction or receipt of immunosuppressive therapy; chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease)
- Co-medications (systemic corticosteroids, more than one dose of systemic antimicrobial therapy within 96 hours, receipt of any investigational drug or vaccine within 30 days)
- Hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame
- Unable to complete study, or no access to phone
- Previously enrolled in this study or currently enrolled in another study
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT01511107
Start Date
January 1 2012
End Date
October 1 2015
Last Update
October 6 2017
Active Locations (2)
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1
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
2
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224