The Norwegian Antibiotics for Pneumonia in Children Study

NCT ID: NCT03446534

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2020-12-31

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.

Conditions

Pneumonia Childhood; Lower Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Amoxicillin

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

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

Imacillin mixture

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo manufactured to mimic amoxicillin mixture (Imacillin)

Interventions

Amoxicillin

Imacillin mixture

Intervention Type: DRUG

Placebos

Placebo manufactured to mimic amoxicillin mixture (Imacillin)

Intervention Type: DRUG

Other Intervention Names

Imacillin

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Alesund Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: collaborator

Klinbeforsk

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Håvard Ove Skjerven

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Håvard O Skjerven

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Ålesund Hospital Trust

Ålesund, , Norway

Site Status: RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status: NOT_YET_RECRUITING

Nordlandssykehuset Bodø

Bodø, , Norway

Site Status: RECRUITING

Østfold Hospital Trust

Grålum, , Norway

Site Status: NOT_YET_RECRUITING

Akershus University Hospital

Lørenskog, , Norway

Site Status: NOT_YET_RECRUITING

Oslo University of Oslo

Oslo, , Norway

Site Status: RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

University Hospital of Northern Norway

Tromsø, , Norway

Site Status: NOT_YET_RECRUITING

St. Olav University Hospital

Trondheim, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Håvard O Skjerven, PhD

Role: CONTACT

h.o.skjerven@medisin.uio.no

+47 41020249

Per Kristian Knudsen, MD

Role: CONTACT

perkristiank@gmail.com

+4791631421

Facility Contacts

Torbjørn Nag

Role: primary

torbjorn.nag@helse-mr.no

41638349

Håvard Trønnes, PhD

Role: primary

havard.tronnes@ihelse.net

95777862

Bjørg Evjenth

Role: primary

bjorg.evjenth@gmail.com

99258992

Jon Olav Hunderi, MD

Role: primary

jon.olav.gjengsto.hunderi@so-hf.no

91880816

Christopher Inchley

Role: primary

christopher.inchley@medisin.uio.no

90069276

Håvard O Skjerven, PhD

Role: primary

h.o.skjerven@medisin.uio.no

41020249

Role: backup

h.o.skjerven@medisin.uio.no

Knut Øymar, PhD

Role: primary

knut.oymar@sus.no

41633426

Claus Klingenberg

Role: primary

claus.klingenberg@unn.no

91563167

Henrik Döllner, PhD

Role: primary

henrik.dollner@ntnu.no

47667169

Other Identifiers

2017/1863

Identifier Type: -

Identifier Source: org_study_id