Pneumonia ChildhoodPhase 4NAPiCNCT03446534
The Norwegian Antibiotics for Pneumonia in Children Study
A Phase 4 study testing Amoxicillin in people with Pneumonia Childhood and Lower Respiratory Tract Infection, run by Oslo University Hospital at 9 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Pneumonia Childhood, Lower Respiratory Tract Infection
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 884 participants
- Where
- 9 sitesNorway
- Study dates
- 7 Mar 2018to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-59 months
- Fever:
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites, 9 recruiting
- Recruiting
Ålesund Hospital Trust
Ålesund, 6017
Torbjørn Nag, 41638349, torbjorn.nag@helse-mr.no
Torbjørn Nag, MD
- Not yet recruiting
Haukeland University Hospital
Bergen, 5021
Håvard Trønnes, PhD, 95777862, havard.tronnes@ihelse.net
Håvard Trønnes, PhD
- Recruiting
Nordlandssykehuset Bodø
Bodø, 8005
Bjørg Evjenth, 99258992, bjorg.evjenth@gmail.com
Bjørg Evjenth, PhD
- Not yet recruiting
Østfold Hospital Trust
Grålum, 1714
Jon Olav Hunderi, MD, 91880816, jon.olav.gjengsto.hunderi@so-hf.no
Jon Olav Hunderi, M.D.
- Not yet recruiting
Akershus University Hospital
Lørenskog, 1478
Christopher Inchley, 90069276, christopher.inchley@medisin.uio.no
Christopher Inchley, PhD
- Recruiting
Oslo University of Oslo
Oslo, 0424
Håvard O Skjerven, PhD, 41020249, h.o.skjerven@medisin.uio.no
h.o.skjerven@medisin.uio.no
- Recruiting
Stavanger University Hospital
Stavanger, 4011
Knut Øymar, PhD, 41633426, knut.oymar@sus.no
Knut Øymar, PhD
- Not yet recruiting
University Hospital of Northern Norway
Tromsø, 9038
Claus Klingenberg, 91563167, claus.klingenberg@unn.no
Claus Klingenberg
- Not yet recruiting
St. Olav University Hospital
Trondheim, 7030
Henrik Döllner, PhD, 47667169, henrik.dollner@ntnu.no
Henrik Döllner, PhD
About this study
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.
Read the 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.
- Being tested
- Amoxicillin, Placebos
- Keywords
- pneumonia, pre-school children, antibiotics, amoxicillin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Imacillin
Imacillin mixture
PlacebosDrug
Placebo manufactured to mimic amoxicillin mixture (Imacillin)
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | Amoxicillin 100mg/ml mixture (Imacillin), 0.25ml/kg every 8 hours for 7 days. Receives: Drug: Amoxicillin |
| Placebo | Placebo comparator | Placebo mixture 0.25ml/kg every 8 hours for 7 days Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Failure
Therapy failure as defined by attending physician, leading to end of intervention and administration of open-label antibiotics
Measured: Within 7 days after inclusion
Secondary outcomes (3)
Thereapy failure leading to intravenous antibiotic therapy
Therapy failure as defined by attending physician, leading to intravenous antibiotic therapy
Measured: Within 7 days after inclusion
Duration of fever
Duration of fever
Measured: Up to 21 days after inclusion
Duration of symptoms of pneumonia
Duration of cough or respiratory distress (tachypnoe, retractions, grunting respiration or nasal flaring.
Measured: Up to 21 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start7 Mar 2018
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 884 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Håvard Ove Skjerven, Oslo University Hospital
- Investigators
- Håvard O Skjerven, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446534
- Sponsor's protocol ID
- 2017/1863
- Acronym
- NAPiC
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian Antibiotics for Pneumonia in Children Study
- ClinicalTrials.gov ID
- NCT03446534
- Acronym / sponsor ID
- NAPiC / 2017/1863
- Keywords
- pneumonia, pre-school children, antibiotics, amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 884 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- 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
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinAmoxicillin 100mg/ml mixture (Imacillin), 0.25ml/kg every 8 hours for 7 days. |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo mixture 0.25ml/kg every 8 hours for 7 days |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age 12-59 months
- Fever:
- 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
- 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
Key exclusion criteria (24 listed)
- Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0°C and at least one of the following:
- Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinAlso: ImacillinImacillin mixture | Drug | Amoxicillin |
| PlacebosPlacebo manufactured to mimic amoxicillin mixture (Imacillin) | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Thereapy failure leading to intravenous antibiotic therapy
Time frame: Within 7 days after inclusion
Duration of fever
Time frame: Up to 21 days after inclusion
Duration of symptoms of pneumonia
Time frame: Up to 21 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvard O Skjerven principal investigator
Oslo University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin in people with Pneumonia Childhood and Lower Respiratory Tract Infection, run by Oslo University Hospital at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Håvard O Skjerven, PhD (+47 41020249, h.o.skjerven@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy Failure (time frame: Within 7 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.