PneumoniaNCT06364514
PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity
A study testing Clinical Stability Assessment in people with Pneumonia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Clinical Stability Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 12 Oct 2026
- Phase
- Interventional
- 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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admitted to the Complex Care Service at Boston Children's Hospital with a provider diagnosis of pneumonia
- Started on antibiotics by the provider team
- Ages 2-25 years old
Who cannot join
- Patients initially admitted to the intermediate care unit or ICU due to increased respiratory support needs
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability.
- Conditions
- Pneumonia
- Being tested
- Clinical Stability Assessment
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Stability AssessmentOther
Base total days of antibiotics on clinical stability vs utilizing predetermined total days of antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will be started on antibiotics for treatment of pneumonia per usual care by their medical provider team. The research team will monitor enrolled patients daily for markers of their clinical status (caregiver assessment of respiratory status, supplemental oxygen/respiratory support, presence of fever). Once the patient has been "clinically stable" x48 hours, antibiotics will be discontinued. Receives: Other: Clinical Stability Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients who consent to participate in the intervention
Caregiver and medical provider acceptability
Measured: 48 hours
Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation
Patient Safety Outcomes
Measured: 1 week
Secondary outcomes (1)
Median days of antibiotics received for patients in the intervention group as well as from historical control group
Pneumonia antibiotic duration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Aug 2024
- Primary completion12 Oct 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Boston Children's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Snow, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364514
- Sponsor's protocol ID
- IRB-P00047313
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2024
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity
- ClinicalTrials.gov ID
- NCT06364514
- Acronym / sponsor ID
- IRB-P00047313
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 15 Apr 2024 (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.
To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Clinical Stability AssessmentPatients will be started on antibiotics for treatment of pneumonia per usual care by their medical provider team. The research team will monitor enrolled patients daily for markers of their clinical status (caregiver assessment of respiratory status, supplemental oxygen/respiratory support, presence of fever). Once the patient has been "clinically stable" x48 hours, antibiotics will be discontinued. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Admitted to the Complex Care Service at Boston Children's Hospital with a provider diagnosis of pneumonia
- Started on antibiotics by the provider team
- Ages 2-25 years old
Key exclusion criteria (1 listed)
- Patients initially admitted to the intermediate care unit or ICU due to increased respiratory support needs
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 |
|---|---|---|
| Clinical Stability AssessmentBase total days of antibiotics on clinical stability vs utilizing predetermined total days of antibiotics | Other | Intervention Group |
Primary outcome
Proportion of eligible patients who consent to participate in the intervention
Time frame: 48 hours
Caregiver and medical provider acceptability
Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation
Time frame: 1 week
Patient Safety Outcomes
1 secondary outcome
Median days of antibiotics received for patients in the intervention group as well as from historical control group
Time frame: 30 days
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 21 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Stability Assessment in people with Pneumonia, run by Boston Children's Hospital at 1 site in United States.
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 3 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 21 Oct 2026. 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 United States. 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.
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?
Proportion of eligible patients who consent to participate in the intervention (time frame: 48 hours). The study lists 2 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 21 Oct 2026.