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Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia

NCT05726253 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-02-15

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726253 on ClinicalTrials.gov