NCT05726253

Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 12 Months – 71 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia
• Pediatric Respiratory Diseases
• Antibiotic Use
• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Supportive Care + Amoxicillin	Participants will be randomized to receive oral amoxicillin for a standard course (7 days)
DRUG	Supportive Care + Placebo (no antibiotics)	Participants will be randomized to receive oral placebo for a standard course (7 days)

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-02-13
• Last updated: 2024-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study