CompletedPhase 3

Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

United States515 participantsStarted 2016-02

Plain-language summary

The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.

Who can participate

Age range

2 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meets criteria for "persistent" or "worsening" presentations of sinusitis * Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale Exclusion Criteria: * Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C * Asthma/allergic rhinitis explains symptoms * Allergy to amoxicillin-clavulanate * Immotile cilia syndrome * Cystic fibrosis * Immunodeficiency * Parental inability to read/write English or Spanish * Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis) * Systemic toxicity * Wheezing on exam * Antibiotic use within 15 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment

Timeframe: Days 2 to 11

The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment

Timeframe: Days 2 to 11

Trial details

NCT IDNCT02554383

SponsorNader Shaikh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

Results submitted2023-03-28

View on ClinicalTrials.gov More Sinusitis trials

Who can participate

Age range

2 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment

Timeframe: Days 2 to 11

The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment

Timeframe: Days 2 to 11