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The Norwegian Antibiotics for Pneumonia in Children Study (NAPiC)

Primary Purpose

Pneumonia Childhood, Lower Respiratory Tract Infection

Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Amoxicillin
Placebos
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia Childhood focused on measuring pneumonia, pre-school children, antibiotics, amoxicillin

Eligibility Criteria

12 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 12-59 months

  2. Fever:

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

  3. 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

  4. ≥ 1 sign of lower airway inflammation

    1. Cough (at inclusion or reported within the last 6 hours)
    2. Chest retractions (jugular, intercoastally or subcoastally)
    3. Grunting respiration
    4. Nasal flaring
    5. Crepitations by pulmonary auscultation
    6. Hypoxia (SpO2 ≤ 90%)
  5. 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:

    1. Bronchial breathing sounds
    2. Unilaterally decreased breath sounds or unilateral percussion dullness
    3. Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.

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

    1. Clinical septicaemia
    2. Urinary tract infection
    3. Meningitis
  3. Systemic antibiotics received within the last 7 days
  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. History of any serious underlying disease that can increase the risk of bacterial pulmonary infections, including but not limited to:

    1. Haematological or oncological
    2. Immunodeficiency
    3. Congenital heart disease
    4. Neuromuscular impairment
    5. Development disorder, including Downs syndrome
    6. Bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases

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

    1. prolonged expiration and
    2. generalised expiratory wheeze
  7. Stridor by auscultation.
  8. History of known or suspected adverse reactions to amoxicillin, or any other betalactam
  9. Participating in another trial that might affect the current study
  10. Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures)

Sites / Locations

  • Haukeland University Hospital
  • Nordlandssykehuset BodøRecruiting
  • Østfold Hospital Trust
  • Akershus University Hospital
  • Oslo University of OsloRecruiting
  • Stavanger University HospitalRecruiting
  • University Hospital of Northern Norway
  • St. Olav University Hospital
  • Ålesund Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Thereapy failure leading to intravenous antibiotic therapy
Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy
Duration of fever
Duration of fever
Duration of symptoms of pneumonia
Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.

Full Information

First Posted
February 17, 2018
Last Updated
April 10, 2018
Sponsor
Oslo University Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03446534
Brief Title
The Norwegian Antibiotics for Pneumonia in Children Study
Acronym
NAPiC
Official Title
The Norwegian Antibiotics for Pneumonia in Children Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Childhood, Lower Respiratory Tract Infection
Keywords
pneumonia, pre-school children, antibiotics, amoxicillin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
884 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Experimental
Arm Description
Amoxicillin 100mg/ml mixture (Imacillin), 0.25ml/kg every 8 hours for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo mixture 0.25ml/kg every 8 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Imacillin
Intervention Description
Imacillin mixture
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo manufactured to mimic amoxicillin mixture (Imacillin)
Primary Outcome Measure Information:
Title
Therapy Failure
Description
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
Secondary Outcome Measure Information:
Title
Thereapy failure leading to intravenous antibiotic therapy
Description
Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy
Time Frame
Within 7 days after inclusion
Title
Duration of fever
Description
Duration of fever
Time Frame
Up to 21 days after inclusion
Title
Duration of symptoms of pneumonia
Description
Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.
Time Frame
Up to 21 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 12-59 months Fever: a. Temperature ≥ 38.0 at inclusion or reported within the last 24 hours 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 Cough (at inclusion or reported within the last 6 hours) 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 Exclusion Criteria: 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 Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial. 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 Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial. 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 Signs of lower obstructive airways with both of the following present by auscultation: prolonged expiration and generalised expiratory wheeze Stridor by auscultation. History of known or suspected adverse reactions to amoxicillin, or any other betalactam Participating in another trial that might affect the current study Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Håvard O Skjerven, PhD
Phone
+47 41020249
Email
h.o.skjerven@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Per Kristian Knudsen, MD
Phone
+4791631421
Email
perkristiank@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvard O Skjerven
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håvard Trønnes, PhD
Phone
95777862
Email
havard.tronnes@ihelse.net
First Name & Middle Initial & Last Name & Degree
Håvard Trønnes, PhD
Facility Name
Nordlandssykehuset Bodø
City
Bodø
ZIP/Postal Code
8005
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjørg Evjenth
Phone
99258992
Email
bjorg.evjenth@gmail.com
First Name & Middle Initial & Last Name & Degree
Bjørg Evjenth, PhD
Facility Name
Østfold Hospital Trust
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Olav Hunderi, MD
Phone
91880816
Email
jon.olav.gjengsto.hunderi@so-hf.no
First Name & Middle Initial & Last Name & Degree
Jon Olav Hunderi, M.D.
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Inchley
Phone
90069276
Email
christopher.inchley@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Christopher Inchley, PhD
Facility Name
Oslo University of Oslo
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håvard O Skjerven, PhD
Phone
41020249
Email
h.o.skjerven@medisin.uio.no
Ext
Skjerven
Email
h.o.skjerven@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Håvard O Skjerven, PhD
First Name & Middle Initial & Last Name & Degree
Per Kristian Knudsen, MD
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Øymar, PhD
Phone
41633426
Email
knut.oymar@sus.no
First Name & Middle Initial & Last Name & Degree
Knut Øymar, PhD
Facility Name
University Hospital of Northern Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Klingenberg
Phone
91563167
Email
claus.klingenberg@unn.no
First Name & Middle Initial & Last Name & Degree
Claus Klingenberg
Facility Name
St. Olav University Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Döllner, PhD
Phone
47667169
Email
henrik.dollner@ntnu.no
First Name & Middle Initial & Last Name & Degree
Henrik Döllner, PhD
Facility Name
Ålesund Hospital Trust
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torbjørn Nag
Phone
41638349
Email
torbjorn.nag@helse-mr.no
First Name & Middle Initial & Last Name & Degree
Torbjørn Nag, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Norwegian Antibiotics for Pneumonia in Children Study

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