PneumoniaPhase 4TRIADNCT07322146
Trial of Reducing Inpatient Antibiotic Durations in Children
A Phase 4 study of Pneumonia and Skin and Soft Tissue (SST) Infection, run by University of California, San Francisco at 10 sites in United States.
Trial summary
Infections like pneumonia, skin and soft tissue infection (also called SSTI or cellulitis), and urinary tract infections (UTI) are some of the most common reasons children get admitted to the hospital. All three of these conditions require antibiotics for treatment. Read more about this study
- Who is it for?
- Ages 60 days to 17 years
- Conditions the study is for
- Pneumonia, Skin and Soft Tissue (SST) Infection, Urinary Tract Infections (UTIs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Feb 2026to Aug 2031
- Phase
- Phase 4
- 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 60 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- We will include children and adolescents ages 60 days to 17 years and 10 months admitted to the hospital medicine service with a primary diagnosis of PNA, SSTI, or UTI receiving an antibiotic agent that is concordant with any microbiologic results and guideline-concordant. Children are eligible if they are prescribed a post-discharge antibiotic for home that is within our trial formulary.
- For PNA, children must have radiographic evidence of pneumonia as read by a radiologist, and clinical diagnosis of pneumonia, and clinician prescription of guideline-concordant antibiotics for pneumonia. For SSTI, we will include children with cellulitis alone or cellulitis with abscess that was either drained or deemed too small for drainage. For UTI, children must meet guideline-specified diagnostic criteria.
Who cannot join
- We will exclude any patients who live independently (without a parent or guardian in the home), including those in county or state custody. We will exclude patients who previously enrolled (i.e., consented and randomized) in the study. We will exclude patients who are not discharging home from hospital medicine service.
- For all conditions, we will exclude children who require inpatient antibiotics longer than 4 days, as guidelines indicate that a child should be clinically improving to be a candidate for short duration treatment strategy. We will also exclude children discharged with >1 systemic antibiotic prescription, as this may indicate greater severity of infection or greater diagnostic uncertainty. Other exclusion criteria are also all aligned with guidelines, which exclude children that may require longer duration antibiotics or have higher risk of infections with resistant or atypical organisms, including exclusion of patients requiring >24 hours in intensive care, patients with immunodeficiency, patients who have been hospitalized in the preceding 30 days before the index hospitalization, patients who are admitted after completing more than 48 hours of outpatient antibiotics to treat the current infection, known pregnant patients, anyone who has an allergy to any of the components of the placebo, and anyone with clear alternate diagnosis, need for treatment of a concomitant diagnosis requiring antibiotics, or uncertainty regarding the qualifying diagnosis (PNA, SSTI, UTI).
- For pneumonia, we will exclude children with a parapneumonic effusion larger than "trace" or "small" (based on radiologist impression), tracheostomy, high intensity neurologic impairment, cystic fibrosis, sickle cell disease, chronic respiratory failure, or received 3 or more doses of azithromycin. For SSTI, we will exclude children with surgical site infections, cellulitis around a medical device, bone or joint infections, infectious myositis or pyomyositis, implanted hardware or other deep infections, have concomitant HSV, significant chronic dermatologic conditions other than eczema, or pre-septal or orbital cellulitis. Dental abscess without overlying facial cellulitis will also be excluded. We will exclude those discharged from the hospital with a drain in place. However, any abscess at the skin would qualify even if it is drained by a subspecialist, unless it connects with an internal cavity. For UTI, we will exclude children with major genitourinary anomalies, high-grade vesicoureteral reflux, history of urologic surgery other than circumcision, indwelling urinary catheters, need for regular intermittent catheterization, or current renal abscess.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Children's Hospital of Colorado
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center Liberty Campus
Cincinnati, Ohio, 45044
Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio, 45229
Primary Children's Hospital
Lehi, Utah, 84043
Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Comparing Two Durations of Antibiotic Treatment for Children Hospitalized With Common Infections
Infections like pneumonia, skin and soft tissue infection (also called SSTI or cellulitis), and urinary tract infections (UTI) are some of the most common reasons children get admitted to the hospital. All three of these conditions require antibiotics for treatment. Although antibiotics are needed to treat the infection and help children feel better, taking them longer than needed can negatively impact children and their families. Negative impacts include things like the burdens of taking more medications and medication side effects. There are guidelines (instructions) from expert medical organizations that suggest the number of days children need antibiotics, but they give a wide range (between 5 and 14 days). Unfortunately, these guidelines are not based on high-quality studies. National data suggests that doctors often choose on the higher end of this range when writing prescriptions for children in the hospital.
Our three caregiver co-investigators, other parents of hospitalized children, doctors, other care providers, and researchers, all believe that additional study is needed to determine the best length of antibiotic treatment that weighs both the benefits and harms of antibiotics.
Read more
The goal of our study is to understand if 5 total days of antibiotic treatment compared to 10 total days of antibiotic treatment is better for children who have been in the hospital for pneumonia, SSTI, or UTI. We will study this question through a randomized control trial. In other words, half of the children will receive 5-days of antibiotics and the other half will receive 10-days of antibiotics. Children in this study (and their caregivers) will not know how many days of antibiotics they will receive to cure their infection because some children will take a placebo (or a pill without antibiotics in it). Only the pharmacy will know if a child is getting antibiotic or placebo (for days 6-10 of treatment).
During the first phase of the trial (feasibility phase), 4 hospitals will enroll children in the study. We plan on enrolling 50 patients during this phase. We are starting with just 4 hospitals, so our study team can create and update our study plans if needed. We will closely review information about how many patients and families agree to participate, and if they have any trouble completing any part of the study. We will also interview families to understand the choice to participate in the study, the choice not to participate in the study, and what it is like to be in the study.
During the second study phase, we will enroll 1150 more patients across all 11 hospitals. Families will complete short, daily surveys until the 15th day after they started antibiotics, then a larger survey at day 15, at day 20, and at day 30. These surveys will ask about the child's symptoms and recovery from their illness, how the antibiotics are making them feel, and if they had to go back to their doctor, emergency room, or hospital. The answers to these questions will be combined to measure how well the child did, balancing feeling better and having bad effects from the antibiotics.
We will use mathematical tests to determine which antibiotic duration is better for treating these illnesses. We will complete other mathematical tests to see if all children should receive the same length of antibiotics or if certain children should be prescribed shorter courses and others longer courses.
- Being tested
- Study Drug Placebo
- Keywords
- Randomized Control Trial, Double-Blinded, Antibiotic duration, Hospital Medicine, Pediatrics
- Medical subject headings
- Pneumonia, Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Drug PlaceboDrug
Placebo, medically nonactive drug
| Study group | Role | What they receive |
|---|---|---|
| 5-day duration treatment strategy | Experimental | Participants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a placebo, for days 6-10 of therapy. Receives: Drug: Study Drug Placebo |
| 10-day duration treatment strategy | No intervention | Participants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a continuation of that antibiotic, for days 6-10 of therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOOR-RADAR composite outcome at day 15
This is a composite, ordinal outcome captured through caregiver survey on day 15 after antibiotic initiation. This outcome includes 3 domains: clinical treatment failure, symptom and function recovery, and antibiotic-associated adverse effects. Each participant is assigned an ordinal outcome category (eight possible categories, each representing a unique combination of the three domains).
Measured: Day 15 after antibiotic initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start13 Feb 2026
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
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 University of California, San FranciscoThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Sunitha V Kaiser, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322146
- Sponsor's protocol ID
- 25-45723
- Acronym
- TRIAD
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited Data Set versions will be distributed to external collaborators with a data use agreement. Any collaborator requiring identifying data elements outside the bounds of a Limited Data Set will first be added formally as research personnel. The Data Coordinatin Center will preserve research data and documentation for sharing and reuse, for 7 years after the study's final report.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Durations of Antibiotic Treatment for Children Hospitalized With Common Infections
- ClinicalTrials.gov ID
- NCT07322146
- Acronym / sponsor ID
- TRIAD / 25-45723
- Keywords
- Randomized Control Trial, Double-Blinded, Antibiotic duration, Hospital Medicine, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 7 Jan 2026 (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.
Infections like pneumonia, skin and soft tissue infection (also called SSTI or cellulitis), and urinary tract infections (UTI) are some of the most common reasons children get admitted to the hospital. All three of these conditions require antibiotics for treatment. Although antibiotics are needed to treat the infection and help children feel better, taking them longer than needed can negatively impact children and their families. Negative impacts include things like the burdens of taking more medications and medication side effects. There are guidelines (instructions) from expert medical organizations that suggest the number of days children need antibiotics, but they give a wide range (between 5 and 14 days). Unfortunately, these guidelines are not based on high-quality studies. National data suggests that doctors often choose on the higher end of this range when writing prescriptions for children in the hospital.
Our three caregiver co-investigators, other parents of hospitalized children, doctors, other care providers, and researchers, all believe that additional study is needed to determine the best length of antibiotic treatment that weighs both the benefits and harms of antibiotics.
The goal of our study is to understand if 5 total days of antibiotic treatment compared to 10 total days of antibiotic treatment is better for children who have been in the hospital for pneumonia, SSTI, or UTI. We will study this question through a randomized control trial. In other words, half of the children will receive 5-days of antibiotics and the other half will receive 10-days of antibiotics. Children in this study (and their caregivers) will not know how many days of antibiotics they will receive to cure their infection because some children will take a placebo (or a pill without antibiotics in it). Only the pharmacy will know if a child is getting antibiotic or placebo (for days 6-10 of treatment).
During the first phase of the trial (feasibility phase), 4 hospitals will enroll children in the study. We plan on enrolling 50 patients during this phase. We are starting with just 4 hospitals, so our study team can create and update our study plans if needed. We will closely review information about how many patients and families agree to participate, and if they have any trouble completing any part of the study. We will also interview families to understand the choice to participate in the study, the choice not to participate in the study, and what it is like to be in the study.
During the second study phase, we will enroll 1150 more patients across all 11 hospitals. Families will complete short, daily surveys until the 15th day after they started antibiotics, then a larger survey at day 15, at day 20, and at day 30. These surveys will ask about the child's symptoms and recovery from their illness, how the antibiotics are making them feel, and if they had to go back to their doctor, emergency room, or hospital. The answers to these questions will be combined to measure how well the child did, balancing feeling better and having bad effects from the antibiotics.
We will use mathematical tests to determine which antibiotic duration is better for treating these illnesses. We will complete other mathematical tests to see if all children should receive the same length of antibiotics or if certain children should be prescribed shorter courses and others longer courses.
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 |
|---|---|---|
| 5-day duration treatment strategy | Experimental | Drug: Study Drug PlaceboParticipants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a placebo, for days 6-10 of therapy. |
| 10-day duration treatment strategy | No intervention | –Participants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a continuation of that antibiotic, for days 6-10 of therapy. |
Who may qualify
- Ages
- 60 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- We will include children and adolescents ages 60 days to 17 years and 10 months admitted to the hospital medicine service with a primary diagnosis of PNA, SSTI, or UTI receiving an antibiotic agent that is concordant with any microbiologic results and guideline-concordant. Children are eligible if they are prescribed a post-discharge antibiotic for home that is within our trial formulary.
- For PNA, children must have radiographic evidence of pneumonia as read by a radiologist, and clinical diagnosis of pneumonia, and clinician prescription of guideline-concordant antibiotics for pneumonia. For SSTI, we will include children with cellulitis alone or cellulitis with abscess that was either drained or deemed too small for drainage. For UTI, children must meet guideline-specified diagnostic criteria.
Key exclusion criteria (3 listed)
- We will exclude any patients who live independently (without a parent or guardian in the home), including those in county or state custody. We will exclude patients who previously enrolled (i.e., consented and randomized) in the study. We will exclude patients who are not discharging home from hospital medicine service.
- For all conditions, we will exclude children who require inpatient antibiotics longer than 4 days, as guidelines indicate that a child should be clinically improving to be a candidate for short duration treatment strategy. We will also exclude children discharged with >1 systemic antibiotic prescription, as this may indicate greater severity of infection or greater diagnostic uncertainty. Other exclusion criteria are also all aligned with guidelines, which exclude children that may require longer duration antibiotics or have higher risk of infections with resistant or atypical organisms, including exclusion of patients requiring >24 hours in intensive care, patients with immunodeficiency, patients who have been hospitalized in the preceding 30 days before the index hospitalization, patients who are admitted after completing more than 48 hours of outpatient antibiotics to treat the current infection, known pregnant patients, anyone who has an allergy to any of the components of the placebo, and anyone with clear alternate diagnosis, need for treatment of a concomitant diagnosis requiring antibiotics, or uncertainty regarding the qualifying diagnosis (PNA, SSTI, UTI).
- For pneumonia, we will exclude children with a parapneumonic effusion larger than "trace" or "small" (based on radiologist impression), tracheostomy, high intensity neurologic impairment, cystic fibrosis, sickle cell disease, chronic respiratory failure, or received 3 or more doses of azithromycin. For SSTI, we will exclude children with surgical site infections, cellulitis around a medical device, bone or joint infections, infectious myositis or pyomyositis, implanted hardware or other deep infections, have concomitant HSV, significant chronic dermatologic conditions other than eczema, or pre-septal or orbital cellulitis. Dental abscess without overlying facial cellulitis will also be excluded. We will exclude those discharged from the hospital with a drain in place. However, any abscess at the skin would qualify even if it is drained by a subspecialist, unless it connects with an internal cavity. For UTI, we will exclude children with major genitourinary anomalies, high-grade vesicoureteral reflux, history of urologic surgery other than circumcision, indwelling urinary catheters, need for regular intermittent catheterization, or current renal abscess.
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 |
|---|---|---|
| Study Drug PlaceboPlacebo, medically nonactive drug | Drug | 5-day duration treatment strategy |
Primary outcome
DOOR-RADAR composite outcome at day 15
Time frame: Day 15 after antibiotic initiation
This is a composite, ordinal outcome captured through caregiver survey on day 15 after antibiotic initiation. This outcome includes 3 domains: clinical treatment failure, symptom and function recovery, and antibiotic-associated adverse effects. Each participant is assigned an ordinal outcome category (eight possible categories, each representing a unique combination of the three domains).
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Limited Data Set versions will be distributed to external collaborators with a data use agreement. Any collaborator requiring identifying data elements outside the bounds of a Limited Data Set will first be added formally as research personnel. The Data Coordinatin Center will preserve research data and documentation for sharing and reuse, for 7 years after the study's final report.
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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.
Sunitha V Kaiser, MD, MSc principal investigator
University of California, San Francisco
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Pneumonia and Skin and Soft Tissue (SST) Infection, run by University of California, San Francisco at 10 sites 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
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?
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?
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?
DOOR-RADAR composite outcome at day 15 (time frame: Day 15 after antibiotic initiation). 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 29 Apr 2026.