Community-acquired PneumoniaPhase 4SAFERNCT02380352
Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
A Phase 4 study testing Amoxicillin in people with Community-acquired Pneumonia, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2016to Apr 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:
- fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation;
- any one of:
- tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age);
- cough on exam or by history;
- increased work of breathing on exam; or
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- auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;
- infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
- the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)
- Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.
Who cannot join
- Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Children's Hospital of Eastern Ontario
Ottawa, Ontario
About this study
Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Amoxicillin, Placebo
- Keywords
- antibiotic stewardship, non-inferiority, randomized controlled trial
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Amoxil
PlaceboDrug
Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.
| Study group | Role | What they receive |
|---|---|---|
| Short-course | Experimental | 5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID Receives: Drug: Amoxicillin; Drug: Placebo |
| Standard | Active comparator | 5 days amoxicillin 90 mg/kg/day divided TID followed by alternate formulation 5 days amoxicillin 90 mg/kg/day divided TID Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
Resolution of tachypnoea, increased work of breathing, and fever
Measured: at 14-21 days post-enrolment
Secondary outcomes (4)
Days of adverse reactions
Measured: up to 14 days post-enrolment
Days of missed school
Measured: up to 14 days post-enrolment
Days of missed/disrupted work for caregiver(s)
Measured: up to 14 days post-enrolment
Adherence to study medications
Measured: up to 10 days post-enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Pernica, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380352
- Sponsor's protocol ID
- SAFER 001 PSI
- Acronym
- SAFER
- Status last verified
- May 2021
- First submitted
- 2 Mar 2015
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
PubMed 33683325Pernica J, Harman S, Kam A, Bailey J, Carciumaru R, Khan S, Fulford M, Thabane L, Slinger R, Main C, Smieja M, Loeb M. Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial. Trials. 2018 Feb 1;19(1):83. doi: 10.1186/s13063-018-2457-2.
PubMed 29391051
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
- ClinicalTrials.gov ID
- NCT02380352
- Acronym / sponsor ID
- SAFER / SAFER 001 PSI
- Conditions
- Community-acquired Pneumonia
- Keywords
- antibiotic stewardship, non-inferiority, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-course | Experimental | Drug: Amoxicillin, Drug: Placebo5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID |
| Standard | Active comparator | Drug: Amoxicillin5 days amoxicillin 90 mg/kg/day divided TID followed by alternate formulation 5 days amoxicillin 90 mg/kg/day divided TID |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:
- fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation;
- any one of:
- infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
- the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)
Key exclusion criteria (1 listed)
- Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.
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: Amoxil | Drug | Short-course, Standard |
| PlaceboExperimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding. | Drug | Short-course |
Primary outcome
Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
Time frame: at 14-21 days post-enrolment
Resolution of tachypnoea, increased work of breathing, and fever
4 secondary outcomes
Days of adverse reactions
Time frame: up to 14 days post-enrolment
Days of missed school
Time frame: up to 14 days post-enrolment
Days of missed/disrupted work for caregiver(s)
Time frame: up to 14 days post-enrolment
Adherence to study medications
Time frame: up to 10 days post-enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 33683325Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
- Derived from this study: PubMed 29391051Pernica J, Harman S, Kam A, Bailey J, Carciumaru R, Khan S, Fulford M, Thabane L, Slinger R, Main C, Smieja M, Loeb M. Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial. Trials. 2018 Feb 1;19(1):83. doi: 10.1186/s13063-018-2457-2.
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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.
Jeffrey M Pernica, MD principal investigator
McMaster University
2 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 Community-acquired Pneumonia, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
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 10 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever) (time frame: at 14-21 days post-enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380352, which also lists 2 linked publications.
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 8 Jun 2021.