Fractures, OpenPhase 4NCT06055712
Antibiotic Prophylaxis in Pediatric Open Fractures
A Phase 4 study testing Cefazolin and Cephalexin in people with Fractures, Open and Infections, run by St. Louis University at 1 site in United States.
Trial summary
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Fractures, Open, Infections
- What is being tested?
- Cefazolin and Cephalexin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to Jan 2034
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients ages 0-17 years old
- Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon
- Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation
- Physician plans to manage the fracture non-operatively
Who cannot join
- Patients 18 years or older
- Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon
- Patients with grade 3 open fractures
- Gross contamination of the fracture
- Fracture requires surgery
- Immunocompromised patients
Show all 9Show fewer
- Allergies to cephalosporins
- Severe penicillin allergy
- non-English speaking patients \&/or guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.
Read the detailed description
Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation. Informed consent form discussion will take place within 8 hours of the patient's presentation, or before their second dose of antibiotics would be due (if randomized to group 2 or 3).
Upon arrival to the ED with an open fracture (grade I or II), the patient is assessed and care is initiated based on patient presentation. Patients are given an IV for medication administration and receive the first dose of antibiotics (cefazolin) as soon as possible. This is standard of care.
Treatment of the fracture includes irrigation with saline (at least 1 liter depending on wound size). The fracture then needs to be stabilized and wound closed. Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture. These practices are standard of care.
If the patient and guardian consent to the study, the patient will be randomized to one of three study arms:
- one dose of IV cefazolin B) 24 hours IV cefazolin (3 doses Q8hrs) C) 24 hours IV cefazolin (3 doses Q8hrs) plus 5 days oral cephalexin.
Patients in group A will have no further antibiotic administration, assuming they received their first (and only) dose as soon as possible upon arrival. Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose. This is why we plan to consent the patients/guardians within 8 hours of presentation.
Aside from antibiotic administration, all other treatment will be standard of care. Patients will undergo closed reduction and any other medical management deemed necessary. Prior to discharge, participants will be educated on how to identify symptoms of infection. It is standard of care to discuss this during discharge education.
Frequency of follow up will be determined by standard of care treatment plan for age and fracture type. This is at the discretion of the physician. Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks. Study team members will check the patient's medical record for indication of infection or adverse events at each follow-up visit. If no follow up is reported after three months, study staff will conduct a phone interview to collect this data.
- Conditions
- Fractures, Open, Infections
- Being tested
- Cefazolin, Cephalexin
- Keywords
- Pediatric open fracture, Antibiotic regimen, Infection rate
- Medical subject headings
- Fractures, Open, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Intravenous dose(s).
CephalexinDrug
Five days oral.
| Study group | Role | What they receive |
|---|---|---|
| One dose of IV cefazolin | Active comparator | Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration. Receives: Drug: Cefazolin |
| 24 hours IV cefazolin | Active comparator | Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Receives: Drug: Cefazolin |
| 24 hours IV cefazolin plus 5 days oral cephalexin | Active comparator | Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin. Receives: Drug: Cefazolin; Drug: Cephalexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an infection at the fracture site.
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.
Measured: Up to 3 months following injury.
Secondary outcomes (1)
Drug adverse events
Any adverse side effects resulting from antibiotics administered.
Measured: Up to 3 months following injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start11 Sep 2023
- Primary completionSep 2033 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, OpenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raju Sivashanmugam, St. Louis University
- Investigators
- Sivashanmugam Raju, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055712
- Sponsor's protocol ID
- 30873
- Status last verified
- Oct 2025
- First submitted
- 20 Sep 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Pediatric Open Fractures
- ClinicalTrials.gov ID
- NCT06055712
- Acronym / sponsor ID
- 30873
- Conditions
- Fractures, Open, Infections
- Keywords
- Pediatric open fracture, Antibiotic regimen, Infection rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 28 Sep 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.
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.
Detailed description
Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation. Informed consent form discussion will take place within 8 hours of the patient's presentation, or before their second dose of antibiotics would be due (if randomized to group 2 or 3).
Upon arrival to the ED with an open fracture (grade I or II), the patient is assessed and care is initiated based on patient presentation. Patients are given an IV for medication administration and receive the first dose of antibiotics (cefazolin) as soon as possible. This is standard of care.
Treatment of the fracture includes irrigation with saline (at least 1 liter depending on wound size). The fracture then needs to be stabilized and wound closed. Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture. These practices are standard of care.
If the patient and guardian consent to the study, the patient will be randomized to one of three study arms:
- one dose of IV cefazolin B) 24 hours IV cefazolin (3 doses Q8hrs) C) 24 hours IV cefazolin (3 doses Q8hrs) plus 5 days oral cephalexin.
Patients in group A will have no further antibiotic administration, assuming they received their first (and only) dose as soon as possible upon arrival. Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose. This is why we plan to consent the patients/guardians within 8 hours of presentation.
Aside from antibiotic administration, all other treatment will be standard of care. Patients will undergo closed reduction and any other medical management deemed necessary. Prior to discharge, participants will be educated on how to identify symptoms of infection. It is standard of care to discuss this during discharge education.
Frequency of follow up will be determined by standard of care treatment plan for age and fracture type. This is at the discretion of the physician. Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks. Study team members will check the patient's medical record for indication of infection or adverse events at each follow-up visit. If no follow up is reported after three months, study staff will conduct a phone interview to collect this data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
| Arm | Type | Receives |
|---|---|---|
| One dose of IV cefazolin | Active comparator | Drug: CefazolinPatients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration. |
| 24 hours IV cefazolin | Active comparator | Drug: CefazolinPatients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). |
| 24 hours IV cefazolin plus 5 days oral cephalexin | Active comparator | Drug: Cefazolin, Drug: CephalexinPatients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients ages 0-17 years old
- Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon
- Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation
- Physician plans to manage the fracture non-operatively
Key exclusion criteria (9 listed)
- Patients 18 years or older
- Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon
- Patients with grade 3 open fractures
- Gross contamination of the fracture
- Fracture requires surgery
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 |
|---|---|---|
| CefazolinIntravenous dose(s). | Drug | 24 hours IV cefazolin, 24 hours IV cefazolin plus 5 days oral cephalexin, One dose of IV cefazolin |
| CephalexinFive days oral. | Drug | 24 hours IV cefazolin plus 5 days oral cephalexin |
Primary outcome
Number of participants with an infection at the fracture site.
Time frame: Up to 3 months following injury.
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.
1 secondary outcome
Drug adverse events
Time frame: Up to 3 months following injury.
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 20 Oct 2025.
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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.
Sivashanmugam Raju, MD principal investigator
St. Louis University
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 Cefazolin and Cephalexin in people with Fractures, Open and Infections, run by St. Louis University 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 4 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: enrolling by invitation, as of the sponsor's last update on 20 Oct 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 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?
Number of participants with an infection at the fracture site. (time frame: Up to 3 months following injury.). 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 20 Oct 2025.