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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)

ConditionAcute Otitis Media (AOM)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-36
SponsorNader Shaikh

About this trial

This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have an ear infection (acute otitis media). Children in the study are randomly assigned (like flipping a coin) to receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine with no active antibiotic). Neither families nor study staff know which treatment the child is receiving during the study. The main goal is to compare how severe children's symptoms are each day while on these treatments. Parents or caregivers will report symptoms daily using a simple electronic diary. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, or how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 6 months to <36 months.

Clinical diagnosis of AOM.

Disqualifiers

Known allergy or other contraindication to oral amoxicillin or clavulanate

Prior use of systemic antibiotics in the last 7 days

History of renal impairment

History of hepatic impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin

    Drug

    Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.

  • Amoxicillin-Clavulanate

    Drug

    Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.

  • Amoxicillin Placebo

    Drug

    Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

  • Amoxicillin-Clavulanate Placebo

    Drug

    Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

Treatment groups

1,100 Participants
are divided into 4 treatment groups
Group A: AmoxicillinActive comparator 1 intervention
Group B: Amoxicillin-ClavulanateActive comparator 1 intervention
Group C: Amoxicillin PlaceboPlacebo comparator 1 intervention
Group D: Amoxicillin-Clavulanate PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average Daily Symptom Burden

Symptom burden measured daily using the Acute Otitis Media Severity of Symptoms Scale (AOM-SOS Version 6.0). AOM-SOS scores range from 0 to 50, with higher scores indicating worse symptoms. Daily scores are averaged over Days 1-10

Time frame
Days 1-10

Secondary outcomes

1

Safety Outcome: Diarrhea

Occurrence of diarrhea, defined as at least 3 watery stools in one day or at least 2 watery stools per day on two consecutive days.

Time frame
Randomization through Day 10
2

Recurrence of Acute Sinusitis or Acute Otitis Media

Occurrence of one or more new episodes of clinically diagnosed acute sinusitis or acute otitis media following resolution of the index episode.

Time frame
Days 11-90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nader Shaikh

Lead sponsor

University of Pittsburgh

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: