Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Completed · Phase 3
Conditions studied: Acute Otitis Media
In brief
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.
Key facts
- Study ID
- NCT02630992
- Run by
- Nader Shaikh
- People needed
- 112
- Starts
- 2015-12-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2018-01-03
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age range: 6 to 23 months
- Evidence of AOM
- Recent (within 48 hours) onset of signs and symptoms.
- Middle ear effusion evidenced by the presence of at least 2 of the following: decreased or absent mobility of the tympanic membrane (TM), yellow of white discoloration of the TM, and/or opacification of the TM
- Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either intense erythema or otalgia or 2+ or 3+ bulging of the TM
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 (e.g., tympanostomy tubes in place, cleft palate, Down syndrome)
- Sensorineural hearing loss (unilateral or bilateral)
- Allergy to amoxicillin or amoxicillin clavulanate
- Recent treatment of AOM within the last 14 days
Where it is running
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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