A Phase 4 interventional study of Amoxicillin and Amoxicillin-Clavulanate in Acute Otitis Media (AOM), sponsored by Nader Shaikh. Recruiting at 5 sites in United States. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Nader Shaikh · Phase 4, Interventional, and Treatment
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.
This is a multi-center, randomized, double-blind, placebo-controlled study designed to better understand whether the choice of antibiotic affects symptom burden in children with acute otitis media (AOM). Children enrolled in the study are randomly assigned to receive amoxicillin, amoxicillin-clavulanate, or a matching placebo. Neither the families nor the study team know which treatment a child is receiving during the study period. The primary objective is to compare average daily symptom severity across treatment groups using validated caregiver-reported symptom scales collected through daily electronic diaries. Analyses will account for baseline symptom severity and a combined fever/age category (temperature ≥38.5°C or age \<12 months). The goal is to provide rigorous, comparative evidence on antibiotic use in this common pediatric infection to support more informed clinical decision-making and responsible antimicrobial prescribing. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, and how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Nader Shaikh is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive oral amoxicillin for the treatment of acute otitis media (AOM). Caregivers will complete daily electronic symptom diaries throughout the treatment period.
Drug: Amoxicillin
Participants randomized to this arm will receive oral amoxicillin-clavulanate for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.
Drug: Amoxicillin-Clavulanate
Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.
Drug: Amoxicillin Placebo
Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.
Drug: Amoxicillin-Clavulanate Placebo
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Drug pages: Amoxicillin · Clavulanic Acid
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
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
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
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
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications and the final study report, including relevant data dictionaries and metadata necessary to interpret the data, will be shared in accordance with PCORI's Policy for Data Management and Data Sharing. The shared data set will include the final cleaned and locked analyzable data set used for primary and secondary analyses reported from the study. Data will be de-identified in accordance with applicable federal and institutional privacy requirements, including the HIPAA Privacy Rule. Supporting documentation necessary to reproduce study findings and facilitate secondary analyses will also be made available.
Time frame: De-identified IPD and supporting documentation will become available after publication of the primary study results and completion of PCORI's peer review and public release process, and no later than 12 months following publication of the primary results. Data and supporting documentation will remain available for at least seven years following study completion, consistent with PCORI policy requirements.
Access criteria: Access to de-identified IPD and supporting documentation may be provided to qualified researchers for scientifically sound secondary research purposes, consistent with participant informed consent, institutional review board (IRB) requirements, and applicable laws and regulations. Requests may require submission of a research proposal, statistical analysis plan, and execution of a data use agreement. Data will be shared through a secure institutional or repository-based mechanism determined by the study team and sponsoring institution. Access decisions will be reviewed by the study investigators and/or designated data access committee in accordance with institutional and PCORI data sharing policies.
Data sharing details ↗ · www.pcori.org
Start is estimated for Oct 2026; primary completion for Dec 2031, 62 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Amoxicillin · Clavulanic Acid
Nader Shaikh