Phase 3
N=112
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02630992 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product — 10; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amoxicillin-Clavulanate potassium (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Nader Shaikh
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product |
10; 30 | — |
| PRIMARY The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product |
12; 60 | — |
| PRIMARY The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product |
10; 30 | — |
| PRIMARY The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product |
15; 57 | — |
| SECONDARY The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit |
4; 31 | — |
| SECONDARY The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit |
8; 56 | — |
| SECONDARY The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit |
23; 11 | — |
| SECONDARY The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit |
31; 31 | — |
| SECONDARY The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1 |
4.69 | — |
| SECONDARY The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2 |
4.75 | — |
| SECONDARY Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1 |
14.36; 15.3; 11.42; 8.07; 9.78; 7.39 | — |
| SECONDARY Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2 |
8.63; 7.49; 7.76; 10.22; 13.00; 10.36 | — |
| SECONDARY Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1 |
1047.67; 2050; 730.50; 338; 842; 313.80 | — |
| SECONDARY Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2 |
407; 655.50; 1125.33; 660.16; 986.95; 866.00 | — |
Summary
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.
Eligibility Criteria
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 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
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
Data sourced from ClinicalTrials.gov (NCT02630992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.