At a glance
ClinicalIndex Comparison Record- ✓Age 6 to 71 months
- ✓Provider diagnosis of CAP with prescribed antibiotic therapy (amoxicillin, amoxicillin-clavulanate, or cefdinir)
- ✓Clinical improvement documented by no fever ≥38.3°C in preceding 24 hours, respiratory rate ≤50 breaths/minute (<2 years) or normal range (≥2 years), and cough severity <3
- ✓Parent or guardian able to understand and comply with study procedures and attend all visits
- ✕Recent systemic antibiotic use within 7 days before CAP diagnosis
- ✕Initial CAP therapy with combination antibiotics (study drug plus one or more additional antibiotics)
- ✕History of anaphylaxis or severe drug allergy to amoxicillin or oral cephalosporins
- ✕Concomitant bacterial infection requiring >5 days of antibiotic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV Double-Blind, Placebo-Controlled, Randomized Trial to Evaluate Short Course vs.Standard Course Outpatient Therapy of Community Acquired Pneumonia in Children (SCOUT-CAP)
In Brief
A Phase 4 clinical trial evaluating Amoxicillin, Amoxicillin-clavulanate, and 2 other interventions for Pneumonia. Completed, enrolled 385 participants across 9 sites.
Detailed Summary
This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care facilities, and emergency departments. Primary objective is to compare the composite overall outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)
Study Details
Timeline
Interventions
Amoxicillin is an aminopenicillin antibiotic
A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo