Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Acute Otitis Media
In brief
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 satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).
Key facts
- Study ID
- NCT01511107
- Run by
- Alejandro Hoberman
- People needed
- 520
- Starts
- 2012-01-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-10-06
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.