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Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia

NCT04963764 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-02-15

Study results available
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Summary

This pilot study will evaluate study processes and feasibility of a future large-scale clinical trial that proposes to test whether low-risk children managed as outpatients with community-acquired pneumonia (CAP) and procalcitonin (PCT) levels \<0.25 ng/mL treated with placebo have a similar clinical response to those treated with antibiotics and fewer adverse effects.

Conditions

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

Interventions

DRUG

Amoxicillin

Participants will be randomized to receive oral amoxicillin for a standard course (10 days)

DRUG

Placebo

Participants will be randomized to receive oral placebo for a standard course (10 days)

Sponsors & Collaborators

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
2021-10-18
Primary Completion
2022-05-27
Completion
2022-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04963764 on ClinicalTrials.gov