Community-acquired PneumoniaPhase 4PRESTO-2NCT06125340
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy
A Phase 4 study testing Amoxicillin in people with Community-acquired Pneumonia, run by Jeffrey at 1 site in Canada.
Trial summary
Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. Read more about this study
- Who is it for?
- Ages 6 months to 18 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
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2024to 1 Jan 2026
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
- documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y);
- cough on exam or by history;
- increased work of breathing on exam; or
- auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.
Who cannot join
- Children will be excluded if: antibiotics have been discontinued; they received >3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Jeffrey Pernica, MD, 9055212100 ext. 77577, pernica@mcmaster.ac
About this study
Official title: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of Short-course Antibiotic Therapy
Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Placebo, Amoxicillin
- 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.
PlaceboDrug
5 days of placebo to be given after 3-5 days of antibiotics
AmoxicillinDrug
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Short-course treatment | Experimental | 5 days of placebo (after participants already received 3-5 days of antibiotics) Receives: Drug: Placebo |
| Standard-duration treatment | Active comparator | 5 days of amoxicillin (after participants already received 3-5 days of antibiotics) Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent success
The proportion of potentially eligible participants who consent
Measured: Day 0
Open-label antibiotic use
The proportion of participants who receive open-label (non-study) antibiotics
Measured: before Day 30
Losses to followup
The proportion of participants lost to follow-up
Measured: before Day 30
Secondary outcomes (7)
Proportion of participants with late clinical response
LCR is defined as:
- clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials
Measured: Day 15
Proportion of participants with repeat hospitalization for CAP
Measured: before Day 30
Proportion of participants with drug-related AEs (any severity)
Measured: before Day 30
Proportion of participants with serious drug AEs
Measured: before Day 30
Proportion of participants with unscheduled ED or urgent care visits
Measured: before Day 30
Proportion of participants with unscheduled primary care visits
Measured: before Day 30
Proportion of participants who develop complicated pneumonia
Complicated defined by effusion, empyaema, necrotizing pneumonia
Measured: before Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start17 Apr 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Jan 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125340
- Sponsor's protocol ID
- HHS-CB 2023-Pernica-2
- Acronym
- PRESTO-2
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of Short-course Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT06125340
- Acronym / sponsor ID
- PRESTO-2 / HHS-CB 2023-Pernica-2
- Conditions
- Community-acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- JeffreyUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.
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 treatment | Experimental | Drug: Placebo5 days of placebo (after participants already received 3-5 days of antibiotics) |
| Standard-duration treatment | Active comparator | Drug: Amoxicillin5 days of amoxicillin (after participants already received 3-5 days of antibiotics) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- - children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
Key exclusion criteria (1 listed)
- Children will be excluded if: antibiotics have been discontinued; they received >3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. 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 |
|---|---|---|
| Placebo5 days of placebo to be given after 3-5 days of antibiotics | Drug | Short-course treatment |
| AmoxicillinStandard-dose amoxicillin (approved by Health Canada) to be given x 5 days. | Drug | Standard-duration treatment |
Primary outcome
Consent success
Time frame: Day 0
The proportion of potentially eligible participants who consent
Open-label antibiotic use
Time frame: before Day 30
The proportion of participants who receive open-label (non-study) antibiotics
Losses to followup
Time frame: before Day 30
The proportion of participants lost to follow-up
7 secondary outcomes
Proportion of participants with late clinical response
Time frame: Day 15
Proportion of participants with repeat hospitalization for CAP
Time frame: before Day 30
Proportion of participants with drug-related AEs (any severity)
Time frame: before Day 30
Proportion of participants with serious drug AEs
Time frame: before Day 30
Proportion of participants with unscheduled ED or urgent care visits
Time frame: before Day 30
Proportion of participants with unscheduled primary care visits
Time frame: before Day 30
Proportion of participants who develop complicated pneumonia
Time frame: before Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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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.
1 site 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 Jeffrey 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 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: status not confirmed, as of the sponsor's last update on 12 Dec 2024. 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 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 Jeffrey Pernica, MD (9055212100 ext. 77577, pernica@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent success (time frame: Day 0). The study lists 3 primary outcomes in all. 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 12 Dec 2024.