This trial is active, not recruiting.

Condition acute otitis media
Treatment amoxicillin-clavulanate potassium
Phase phase 3
Sponsor University of Pittsburgh
Start date December 2015
End date December 2016
Trial size 70 participants
Trial identifier NCT02630992, PRO15080192


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 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose other
Masking no masking
amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid
amoxicillin-clavulanate potassium Augmentin
amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg in two divided doses for 10 days.

Primary Outcomes

The proportion of participants who develop Protocol-Defined Diarrhea
time frame: 14 days

Secondary Outcomes

Pharmacokinetics: Urine and/or blood samples to determine the level of clavulanate potassium
time frame: 14 days
Proportion of Subjects Considered a Clinical Success at Day 7
time frame: 7 days
Proportion of Subjects Considered a Clinical Success at Day 12-14 Visit
time frame: 12-14 days
Parent or Guardian's Level of Satisfaction with Therapy assessed by a questionnaire
time frame: 14 days

Eligibility Criteria

All participants from 6 months up to 23 months old.

Inclusion Criteria: - 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 TM, yellow of white discoloration of the TM (tympanic membrane), 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 Exclusion Criteria: - 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

Additional Information

Official title Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Principal investigator Nader Shaikh, MD, MPH
Description Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative pathogens in acute otitis media (AOM) with resulting high clinical cure rates at end-of-treatment (85%). However, relatively high rates (~25%) of clinically significant diarrhea have been reported, the occurrence of which has been directly related to the clavulanate potassium component of the drug combination. A reduced concentration of clavulanate potassium in the drug formulation would be expected to have an improved safety profile regarding the occurrence of diarrhea. This study will examine whether the concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium could be reduced in the treatment of children 6 months through 23 months of age diagnosed with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg in two divided doses for 10 days. The primary outcome measure will be rates of clinically significant diarrhea and diaper dermatitis. These rates will be compared with the rate observed in our previous studies of AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1) administered at 90/6.4 mg/kg in two divided doses for 10 days. A subset of this group will have pharmacokinetic studies performed. Each participant that agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and clavulanate potassium in the blood samples using validated methods.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by University of Pittsburgh.