Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia
Condition: Pneumonia; Pediatric Respiratory Diseases; Antibiotic Use; Community-acquired Pneumonia
MeSH terms: Pneumonia; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      National guidelines make two recommendations for treatment of young children with mild
      pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics.
      No studies have compared the effectiveness of these two approaches. This pilot study will
      evaluate study processes and feasibility of a future clinical trial that proposes to test
      whether low-risk children managed as outpatients with mild community-acquired pneumonia (CAP)
      treated with supportive treatment without antibiotics will have a similar clinical response,
      with fewer adverse effects, compared with those treated with a supportive treatment plan that
      includes antibiotics.
    

Detailed description: 
      This pilot clinical trial is a randomized, placebo-controlled, double-blinded trial assessing
      the feasibility of comparing supportive care+amoxicillin to supportive care without
      antibiotics (i.e., placebo) in children 12 months to <6 years of age who present to the ED
      with community-acquired pneumonia (CAP) and who will be treated as outpatients.

      This trial will enroll over a 6-month period and take place at Ann and Robert H. Lurie
      Children's Hospital of Chicago. Clinical research coordinators (CRCs) will screen for and
      enroll eligible children.

      Through an online system, participants will be randomized to a 7-day course of either
      amoxicillin (80-100 mg/kg divided BID up to 4,000 mg/day) or matching placebo. All patients
      will receive a supportive care treatment bundle that includes antipyretics, honey, and saline
      spray, in addition to instructions on how to manage lower respiratory infections.

      The guardians of participants will be asked to complete an online daily symptom diary during
      the first 6 days after the initial study visit. Participants will have daily telehealth
      evaluations by clinicians for the first three days after the index study visit. The primary
      outcome will be assessed at day 7, using telehealth technology. A final follow-up, performed
      by site research staff, by telephone call, will occur at Day 21 to assess overall disease
      course and secondary outcomes.
    

Intervention name(s): Supportive Care + Amoxicillin; Supportive Care + Placebo (no antibiotics)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomized to receive oral amoxicillin for a standard course (7 days); Participants will be randomized to receive oral placebo for a standard course (7 days)
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot Feasibility Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pediatrics; Pediatric CAP; Pediatric Pneumonia; Antibiotic Use