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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03446534
Other study ID # 2017/1863
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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