NCT03446534

The Norwegian Antibiotics for Pneumonia in Children Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 884 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of amoxicillin in the treatment of lower airway infections in preschool children. Half of the patients will receive amoxicillin, while the other half will receive placebo.

Detailed description

The overall objective of the study is to determine if antibiotic therapy is beneficial in children with pneumonia who do not have a highly suspicious bacterial infection, such as in lobar pneumonia. Secondary objective is to determine whether antibiotic use influence the microbial flora, including antibiotic resistance, in the airways in the short or medium long term. The study is a phase IV double-blind, placebo-controlled, multicenter, nationwide, randomized superiority trial of amoxicillin versus placebo in children aged 1-5 years of age with a lower respiratory infection.

Conditions

• Pneumonia Childhood
• Lower Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Amoxicillin	Imacillin mixture
DRUG	Placebos	Placebo manufactured to mimic amoxicillin mixture (Imacillin)

Timeline

• Start date: 2018-03-07
• Primary completion: 2020-05-01
• Completion: 2020-12-01
• First posted: 2018-02-26
• Last updated: 2018-04-11

Locations

9 sites across 1 country: Norway