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NAPiC: The Norwegian Antibiotics for Pneumonia in Children Study

Sponsor
Oslo University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03446534
Collaborator
Ostfold Hospital Trust (Other), Helse Stavanger HF (Other), Haukeland University Hospital (Other), Alesund Hospital (Other), St. Olavs Hospital (Other), Nordlandssykehuset HF (Other), University Hospital of North Norway (Other), University Hospital, Akershus (Other), Norwegian Institute of Public Health (Other), Klinbeforsk (Other)
884
Enrollment
9
Locations
2
Arms
32.9
Anticipated Duration (Months)
98.2
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
884 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Norwegian Antibiotics for Pneumonia in Children Study
Actual Study Start Date :
Mar 7, 2018
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Amoxicillin

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

Drug: Amoxicillin
Imacillin mixture
Other Names:
  • Imacillin

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebos
    Placebo manufactured to mimic amoxicillin mixture (Imacillin)

    Outcome Measures

    Primary Outcome Measures

    1. Therapy Failure [Within 7 days after inclusion]

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

    Secondary Outcome Measures

    1. Thereapy failure leading to intravenous antibiotic therapy [Within 7 days after inclusion]

      Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy

    2. Duration of fever [Up to 21 days after inclusion]

      Duration of fever

    3. Duration of symptoms of pneumonia [Up to 21 days after inclusion]

      Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 59 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 12-59 months

    2. Fever:

    1. Temperature ≥ 38.0 at inclusion or reported within the last 24 hours

    1. 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

    2. ≥ 1 sign of lower airway inflammation

    3. Cough (at inclusion or reported within the last 6 hours)

    4. Chest retractions (jugular, intercoastally or subcoastally)

    5. Grunting respiration

    6. Nasal flaring

    7. Crepitations by pulmonary auscultation

    8. Hypoxia (SpO2 ≤ 90%)

    9. 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

    Exclusion Criteria:

    1. Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0°C and at least one of the following:

    2. Bronchial breathing sounds

    3. Unilaterally decreased breath sounds or unilateral percussion dullness

    4. Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.

    5. Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively:

    6. Clinical septicaemia

    7. Urinary tract infection

    8. Meningitis

    9. Systemic antibiotics received within the last 7 days

    10. Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.

    11. History of any serious underlying disease that can increase the risk of bacterial pulmonary infections, including but not limited to:

    12. Haematological or oncological

    13. Immunodeficiency

    14. Congenital heart disease

    15. Neuromuscular impairment

    16. Development disorder, including Downs syndrome

    17. Bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases

    18. Signs of lower obstructive airways with both of the following present by auscultation:

    19. prolonged expiration and

    20. generalised expiratory wheeze

    21. Stridor by auscultation.

    22. History of known or suspected adverse reactions to amoxicillin, or any other betalactam

    23. Participating in another trial that might affect the current study

    24. Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Norway 5021
    2 Nordlandssykehuset Bodø Bodø Norway 8005
    3 Østfold Hospital Trust Grålum Norway 1714
    4 Akershus University Hospital Lørenskog Norway 1478
    5 Oslo University of Oslo Oslo Norway 0424
    6 Stavanger University Hospital Stavanger Norway 4011
    7 University Hospital of Northern Norway Tromsø Norway 9038
    8 St. Olav University Hospital Trondheim Norway 7030
    9 Ålesund Hospital Trust Ålesund Norway 6017

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Håvard O Skjerven, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Håvard Ove Skjerven, Consultant, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03446534
    Other Study ID Numbers:
    • 2017/1863
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    Apr 11, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Håvard Ove Skjerven, Consultant, Oslo University Hospital
    pneumonia
    pre-school children
    antibiotics
    amoxicillin
    Additional relevant MeSH terms:
    Pneumonia
    Respiratory Tract Infections
    Amoxicillin

    Study Results

    No Results Posted as of Apr 11, 2018