The Norwegian Antibiotics for Pneumonia in Children Study (NAPiC)

April 10, 2018 updated by: Håvard Ove Skjerven, Oslo University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
884

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Not yet recruiting
        • Haukeland University Hospital
        • Contact:
        • Principal Investigator:
          • Håvard Trønnes, PhD
      • Bodø, Norway, 8005
        • Recruiting
        • Nordlandssykehuset Bodø
        • Contact:
        • Principal Investigator:
          • Bjørg Evjenth, PhD
      • Grålum, Norway, 1714
        • Not yet recruiting
        • Østfold Hospital Trust
        • Contact:
        • Principal Investigator:
          • Jon Olav Hunderi, M.D.
      • Lørenskog, Norway, 1478
        • Not yet recruiting
        • Akershus University Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Inchley, PhD
      • Oslo, Norway, 0424
      • Stavanger, Norway, 4011
        • Recruiting
        • Stavanger University Hospital
        • Contact:
        • Principal Investigator:
          • Knut Øymar, PhD
      • Tromsø, Norway, 9038
        • Not yet recruiting
        • University Hospital of Northern Norway
        • Contact:
        • Principal Investigator:
          • Claus Klingenberg
      • Trondheim, Norway, 7030
        • Not yet recruiting
        • St. Olav University Hospital
        • Contact:
        • Principal Investigator:
          • Henrik Döllner, PhD
      • Ålesund, Norway, 6017
        • Recruiting
        • Ålesund Hospital Trust
        • Contact:
        • Principal Investigator:
          • Torbjørn Nag, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapy Failure
Time Frame: Within 7 days after inclusion
Therapy failure as defined by attending physician, leading to end of intervention and administration of open-label antibiotics
Within 7 days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Thereapy failure leading to intravenous antibiotic therapy
Time Frame: Within 7 days after inclusion
Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy
Within 7 days after inclusion
Duration of fever
Time Frame: Up to 21 days after inclusion
Duration of fever
Up to 21 days after inclusion
Duration of symptoms of pneumonia
Time Frame: Up to 21 days after inclusion
Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.
Up to 21 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian Institute of Public Health
University Hospital of North Norway
Ostfold Hospital Trust
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
Alesund Hospital
University Hospital, Akershus
Nordlandssykehuset HF
Klinbeforsk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Håvard O Skjerven, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/1863

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Respiratory Tract Infection

Clinical Trials on Amoxicillin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings