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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
884
Imacillin mixture
Placebo manufactured to mimic amoxicillin mixture (Imacillin)
Ålesund Hospital Trust
Ålesund, Norway
RECRUITINGHaukeland University Hospital
Bergen, Norway
NOT_YET_RECRUITINGNordlandssykehuset Bodø
Bodø, Norway
Therapy Failure
Therapy failure as defined by attending physician, leading to end of intervention and administration of open-label antibiotics
Time frame: Within 7 days after inclusion
Thereapy failure leading to intravenous antibiotic therapy
Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy
Time frame: Within 7 days after inclusion
Duration of fever
Duration of fever
Time frame: Up to 21 days after inclusion
Duration of symptoms of pneumonia
Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.
Time frame: Up to 21 days after inclusion
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Østfold Hospital Trust
Grålum, Norway
NOT_YET_RECRUITINGAkershus University Hospital
Lørenskog, Norway
NOT_YET_RECRUITINGOslo University of Oslo
Oslo, Norway
RECRUITINGStavanger University Hospital
Stavanger, Norway
RECRUITINGUniversity Hospital of Northern Norway
Tromsø, Norway
NOT_YET_RECRUITINGSt. Olav University Hospital
Trondheim, Norway
NOT_YET_RECRUITING