Community-acquired PneumoniaPhase 2/3NCT03031210
Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
A Phase 2/3 study testing Amoxicillin in people with Community-acquired Pneumonia, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED). Read more about this study
- Who is it for?
- Ages 3 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,370 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2017to 1 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 3 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:
- Presence of respiratory symptoms (cough and/or dyspnea)
- Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
- Presence of fever
- Positive chest radiography as interpreted by the treating physician
Who cannot join
- Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)
- History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.
- History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.
- Caregiver unable to provide consent (language barrier or lack of caregiver presence)
- Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)
- Persistent/chronic pneumonia syndromes (with symptoms for >2 weeks), suspected by the physician to be caused by atypical pathogens, hospital- acquired pneumonia (been hospitalized within 2 weeks prior to enrolment), aspiration pneumonia or recurrent pneumonias.
Show all 9Show fewer
- Any history of receiving amoxicillin within the past month
- Need hospitalisation for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicaemia or meningitis requiring intravenous antimicrobial agents)
- Previous participation in study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T1C5
Jocelyn Gravel, MD, 514-345-4931 ext. 2559, graveljocelyn@hotmail.com
Ariane Boutin, MD, 514-345-4931, arianeboutin@gmail.com
About this study
Official title: Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).
Read the detailed description
A single-center, non-blinded, pragmatic, randomized-controlled, non-inferiority clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All patients three months old to 18 years of age who had symptoms and signs suggestive of non-severe community acquired pneumonia based on respiratory complaints and a pulmonary infiltrate identified by trained paediatricians or emergency physicians will be eligible to the present study. Study participants will be randomly allocated to receive either amoxicillin (90mg/kg per day) in twice or thrice daily regimen. Primary outcome will be treatment failure within 10 days of enrolment as defined by hospitalisation, need for a change in antibiotic (persistence of fever at 72 hours, clinical deterioration, comorbid condition or development of serious adverse reactions) and death. ED revisits within 72 hours, second course of antibiotic and clinical recurrence rates will be evaluated in the follow-up assessments as well as percent of adverse events encountered, number of days missed (work, school or daycare), coverage vaccination rate, protocol adherence and patient and parental satisfaction. The primary analysis will use an intention-to-treat approach. Per-protocol analysis will also be carried to compare the failure rate. Accounting to a maximal 10% drop-off rate, a sample size of 685 participants per arm was calculated to have a power of 90% to identify a difference of ≤ 5% with an alpha value of 0.05.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Amoxicillin
- Keywords
- Non-severe community-acquired pneumonia, Amoxicillin treatment, Twice daily antibiotic regimen
- 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
(90 mg/kg/day) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Twice a day regimen | Experimental | Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily. Receives: Drug: Amoxicillin |
| Thrice a day regimen | Active comparator | Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure within 10 days of enrolment
As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment:
- Death or hospitalisation
- A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are:
- Persistence of fever at 72h
- Clinical deterioration:
- Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment.
- Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis
- Allergic reaction
Measured: Day 10 (after enrolment)
Secondary outcomes (6)
Emergency department revisit within 72 hours
Return to the emergency department in the following 72 hours
Measured: 72 hours
Second course of antibiotic
Necessity of second course of antibiotics
Measured: 1 month
Clinical recurrence
Another diagnosis of pneumonia
Measured: 1 month
Adverse events
Any adverse event
Measured: 10 days
Number of working days missed by caregivers or school/daycare days missed by patients
Total number of days missed by caregivers or school/daycare days missed by the parents
Measured: 1 month
Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration
Measured on a likert scale through a telephone survey
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start11 Jun 2017
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
- Investigators
- Jocelyn Gravel, MD, Principal investigator, Sainte-Justine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031210
- Sponsor's protocol ID
- BID pneumonia
- Status last verified
- May 2025
- First submitted
- 23 Jan 2017
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT03031210
- Acronym / sponsor ID
- BID pneumonia
- Conditions
- Community-acquired Pneumonia
- Keywords
- Non-severe community-acquired pneumonia, Amoxicillin treatment, Twice daily antibiotic regimen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,370 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 11 Jun 2017 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Jan 2017 (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.
The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).
Detailed description
A single-center, non-blinded, pragmatic, randomized-controlled, non-inferiority clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All patients three months old to 18 years of age who had symptoms and signs suggestive of non-severe community acquired pneumonia based on respiratory complaints and a pulmonary infiltrate identified by trained paediatricians or emergency physicians will be eligible to the present study. Study participants will be randomly allocated to receive either amoxicillin (90mg/kg per day) in twice or thrice daily regimen. Primary outcome will be treatment failure within 10 days of enrolment as defined by hospitalisation, need for a change in antibiotic (persistence of fever at 72 hours, clinical deterioration, comorbid condition or development of serious adverse reactions) and death. ED revisits within 72 hours, second course of antibiotic and clinical recurrence rates will be evaluated in the follow-up assessments as well as percent of adverse events encountered, number of days missed (work, school or daycare), coverage vaccination rate, protocol adherence and patient and parental satisfaction. The primary analysis will use an intention-to-treat approach. Per-protocol analysis will also be carried to compare the failure rate. Accounting to a maximal 10% drop-off rate, a sample size of 685 participants per arm was calculated to have a power of 90% to identify a difference of ≤ 5% with an alpha value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twice a day regimen | Experimental | Drug: AmoxicillinPatients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily. |
| Thrice a day regimen | Active comparator | Drug: AmoxicillinPatients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:
Key exclusion criteria (9 listed)
- Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)
- History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.
- History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.
- Caregiver unable to provide consent (language barrier or lack of caregiver presence)
- Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)
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(90 mg/kg/day) twice daily | Drug | Thrice a day regimen, Twice a day regimen |
Primary outcome
Clinical failure within 10 days of enrolment
Time frame: Day 10 (after enrolment)
As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment: * Death or hospitalisation * A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are: * Persistence of fever at 72h * Clinical deterioration: • Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment. * Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis * Allergic reaction
6 secondary outcomes
Emergency department revisit within 72 hours
Time frame: 72 hours
Second course of antibiotic
Time frame: 1 month
Clinical recurrence
Time frame: 1 month
Adverse events
Time frame: 10 days
Number of working days missed by caregivers or school/daycare days missed by patients
Time frame: 1 month
Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- 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.
Jocelyn Gravel, MD principal investigator
Sainte-Justine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amoxicillin in people with Community-acquired Pneumonia, run by St. Justine's Hospital at 1 site 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyn Gravel, MD (514-345-4931 ext. 2559, graveljocelyn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical failure within 10 days of enrolment (time frame: Day 10 (after enrolment)). 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 14 May 2025.