Amoxicillin-Clavulanate
Treatment for Otitis Media
Typical Dosage: 90 mg/kg/day (amoxicillin component) in 2 divided doses
Effectiveness
80%
Safety Score
68%
Clinical Trials
17
Participants
20K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
68
DangerousModerateSafe
Treatment Details
Dosage Range
90 mg/kg/day (amoxicillin component) in 2 divided doses
Time to Effect
2-3 days
Treatment Duration
5-10 days
Evidence Quality
HIGHNumber Needed to Treat (NNT)
7(Treat 7 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
7(Treat 7 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$50
Monitoring:$50
Side Effect Mgmt:$20
Total Annual:$120
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
MODERATEQALYs Gained
0.02
Outcome-Based Costs
Cost per Responder
$141
Cost per Remission
$150
Comparison vs Amoxicillin
Cost Difference
+$50/year
More expensive
QALY Difference
+0.01 QALYs
Better outcomes
Dominance
No dominance
Prescription Access Economics
Physician Visit Cost
$150/year
Time Cost
$50/year
Travel + wait time
Insurance Admin Cost
$15/year
Prior auth, claims
Rx Price
$50/year
Risk Assessment
Misuse Risk
HIGHMissed Diagnosis Risk
LOWAmoxicillin-Clavulanate Outcomes
for Otitis Media
Efficacy Outcomes
Overall Effectiveness
+80%
Response Rate
+85%
Remission Rate
+80%
Common Side Effects
Diarrhea
+25%
Nausea/Vomiting
+8%
Rash
+3%
Sources:
Active Clinical Trials
2 active trials recruiting for Amoxicillin-Clavulanate in Otitis Media
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
NCT07730814NOT YET RECRUITINGPHASE4
1.1K participants
INTERVENTIONAL
Denver, United States +4 more
Started: Oct 1, 2026
Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children
NCT06895135NOT YET RECRUITINGNA
162 participants
INTERVENTIONAL
Started: May 1, 2025
Completed Clinical Trials
14 completed trials for Amoxicillin-Clavulanate in Otitis Media
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
NCT02630992COMPLETEDPHASE3
112 participants
INTERVENTIONAL
Pittsburgh, United States
Started: Dec 1, 2015
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
NCT01244581COMPLETEDPHASE3
84 participants
INTERVENTIONAL
Oulu, Finland +1 more
Started: Sep 1, 1999
Acute Otitis Media (AOM) Therapy Trial in Young Children
NCT00377260COMPLETEDPHASE4
291 participants
INTERVENTIONAL
Pittsburgh, United States
Started: Nov 1, 2006
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
NCT02935374COMPLETEDPHASE4
73 participants
INTERVENTIONAL
Oulu, Finland
Started: Nov 1, 2016
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
NCT00051753COMPLETEDPHASE3
1.64K participants
INTERVENTIONAL
Started: Nov 1, 2002
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
NCT04600752COMPLETEDPHASE4
310 participants
INTERVENTIONAL
Raipur, India +12 more
Started: May 7, 2022
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
NCT03818815COMPLETEDPHASE2
103 participants
INTERVENTIONAL
Pittsburgh, United States
Started: Feb 21, 2019
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
NCT00643292COMPLETEDPHASE3
902 participants
INTERVENTIONAL
Jonesboro, United States +47 more
Started: Jan 1, 2003
Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
NCT01406275COMPLETED
363 participants
OBSERVATIONAL
Started: Jan 1, 2008
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
NCT00644943COMPLETEDPHASE4
425 participants
INTERVENTIONAL
Birmingham, United States +31 more
Started: Feb 1, 2003
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
NCT02567825COMPLETEDNA
250 participants
INTERVENTIONAL
Washington D.C., United States +1 more
Started: Nov 1, 2015
Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
NCT07015736COMPLETEDPHASE4
100 participants
INTERVENTIONAL
Eskişehir, Turkey (Türkiye) +3 more
Started: Aug 1, 2025
Comparative Effectiveness of Antibiotics for Respiratory Infections
NCT02297815COMPLETED
2.47K participants
OBSERVATIONAL
Philadelphia, United States
Started: Jan 1, 2014
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
NCT05804123COMPLETEDNA
175 participants
INTERVENTIONAL
Thái Bình, Vietnam
Started: Oct 28, 2021