The Norwegian Antibiotics for Pneumonia in Children Study

Lower Respiratory Tract Infection Clinical Trial

— NAPiC  

Official title:

The Norwegian Antibiotics for Pneumonia in Children Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03446534
• Other study ID #: 2017/1863
• Status: Recruiting
• Phase: Phase 4
• First received: February 17, 2018
• Last updated: April 10, 2018
• Start date: March 7, 2018
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: Oslo University Hospital
• Contact: Håvard O Skjerven, PhD
• Phone: +47 41020249
• Email: h.o.skjerven[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 884
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 59 Months

Eligibility

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)

Related Conditions & MeSH terms

• Lower Respiratory Tract Infection
• Pneumonia
• Pneumonia Childhood
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Norway	Ålesund Hospital Trust	Ålesund
Norway	Haukeland University Hospital	Bergen
Norway	Nordlandssykehuset Bodø	Bodø
Norway	Østfold Hospital Trust	Grålum
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University of Oslo	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	University Hospital of Northern Norway	Tromsø
Norway	St. Olav University Hospital	Trondheim

Sponsors (11)

Lead Sponsor	Collaborator
Oslo University Hospital	Alesund Hospital, Haukeland University Hospital, Helse Stavanger HF, KLINBEFORSK, Nordlandssykehuset HF, Norwegian Institute of Public Health, Ostfold Hospital Trust, St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Thereapy failure leading to intravenous antibiotic therapy	Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy	Within 7 days after inclusion
Secondary	Duration of fever	Duration of fever	Up to 21 days after inclusion
Secondary	Duration of symptoms of pneumonia	Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.	Up to 21 days after inclusion