The Norwegian Antibiotics for Pneumonia in Children Study

NCT03446534 | Unknown Phase 4 DMC

• 1 other identifier: 2017/1863
• Study Type: interventional
• Target: 884
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Pneumonia Childhood; Lower Respiratory Tract Infection

Keywords

pneumonia; pre-school children; antibiotics; amoxicillin

Outcome Measures

Primary Outcomes (1)

• Therapy Failure

  Therapy failure as defined by attending physician, leading to end of intervention and administration of open-label antibiotics

  Within 7 days after inclusion

Secondary Outcomes (3)

• Thereapy failure leading to intravenous antibiotic therapy

  Within 7 days after inclusion

• Duration of fever

  Up to 21 days after inclusion

• Duration of symptoms of pneumonia

  Up to 21 days after inclusion

Study Arms (2)

Amoxicillin

EXPERIMENTAL

Amoxicillin 100mg/ml mixture (Imacillin), 0.25ml/kg every 8 hours for 7 days.

Drug: Amoxicillin

Placebo

PLACEBO COMPARATOR

Placebo mixture 0.25ml/kg every 8 hours for 7 days

Drug: Placebos

Interventions

Amoxicillin DRUG

Imacillin mixture

Also known as: Imacillin

Amoxicillin

Placebos DRUG

Placebo manufactured to mimic amoxicillin mixture (Imacillin)

Placebo

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-59 months
• Fever:
• Tachypnoe, age specific 12-17mnd ≥ 46 breaths per minute 18-23mnd ≥ 40 breaths per minute 24-35mnd ≥ 34 breaths per minute 36-47mnd ≥ 29 breaths per minute 48-59mnd ≥ 27 breaths per minute
• ≥ 1 sign of lower airway inflammation
• Chest retractions (jugular, intercoastally or subcoastally)
• Grunting respiration
• Nasal flaring
• Crepitations by pulmonary auscultation
• Hypoxia (SpO2 ≤ 90%)
• Weight between 6.0 and 28.0 kg. • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations

You may not qualify if:

• Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0°C and at least one of the following:
• Bronchial breathing sounds
• Unilaterally decreased breath sounds or unilateral percussion dullness
• Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively:
• Clinical septicaemia
• Urinary tract infection
• Meningitis
• Systemic antibiotics received within the last 7 days
• History of any serious underlying disease that can increase the risk of bacterial pulmonary infections, including but not limited to:
• Haematological or oncological
• Immunodeficiency
• Congenital heart disease
• Neuromuscular impairment
• Development disorder, including Downs syndrome
• Bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases

Sponsors & Collaborators

• Oslo University Hospital: lead
• Ostfold Hospital Trust: collaborator
• Helse Stavanger HF: collaborator
• Haukeland University Hospital: collaborator
• Alesund Hospital: collaborator
• St. Olavs Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• University Hospital of North Norway: collaborator
• University Hospital, Akershus: collaborator
• Norwegian Institute of Public Health: collaborator
• Klinbeforsk: collaborator

Study Sites (9)

Ålesund Hospital Trust

Ålesund, 6017, Norway

RECRUITING

Haukeland University Hospital

Bergen, 5021, Norway

NOT YET RECRUITING

Nordlandssykehuset Bodø

Bodø, 8005, Norway

RECRUITING

Østfold Hospital Trust

Grålum, 1714, Norway

NOT YET RECRUITING

Akershus University Hospital

Lørenskog, 1478, Norway

NOT YET RECRUITING

Oslo University of Oslo

Oslo, 0424, Norway

RECRUITING

Stavanger University Hospital

Stavanger, 4011, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, 9038, Norway

NOT YET RECRUITING

St. Olav University Hospital

Trondheim, 7030, Norway

NOT YET RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Håvard O Skjerven

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Håvard O Skjerven, PhD

CONTACT

+47 41020249; h.o.skjerven@medisin.uio.no

Per Kristian Knudsen, MD

CONTACT

+4791631421; perkristiank@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: 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 Record Dates

• First Submitted: February 17, 2018
• First Posted: February 26, 2018
• Study Start: March 7, 2018
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)