Antibiotics for Pediatric Broken Bones

Enrolling by invitation at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Louis University

Must not be taking: Cephalosporins, Penicillin

Disqualifiers: Age 18+, Skeletally mature, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 to 6 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different antibiotic treatments to determine which best prevents infections in children with minor open fractures (where the bone slightly protrudes through the skin). It compares three options: a single dose of IV cefazolin, 24 hours of IV cefazolin, and a combination of 24 hours of IV cefazolin plus 5 days of oral cephalexin. Suitable candidates are those under 18 with a grade 1 or 2 open fracture, whose doctors plan to treat the fracture without surgery. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Studies have shown that cefazolin commonly treats open fractures in children. Administered through an IV (a tube into a vein), it quickly combats bacteria and prevents infections. Research has indicated that this antibiotic is safe, especially in hospitals where it is frequently used.

For cephalexin, research suggests it is generally safe for most people. Common side effects, such as skin rashes or stomach issues, are mild, affecting only about 5% of users. It is often combined with other antibiotics to treat more serious injuries, like open fractures.

Both cefazolin and cephalexin have long been used to treat infections and are usually well-tolerated. This study is in Phase 4, indicating that both antibiotics have already been approved for other uses, supporting their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for pediatric broken bones because they explore how different antibiotic regimens can potentially reduce infection risks. Unlike the standard practice, which often involves multiple doses or extended antibiotic courses, one approach tests the effectiveness of a single dose of IV cefazolin, aiming to minimize antibiotic exposure. Another approach combines 24 hours of IV cefazolin with a five-day course of oral cephalexin, which could offer a more comprehensive treatment while still potentially reducing the total duration of antibiotics. These variations could lead to more efficient use of antibiotics, reducing side effects and resistance while ensuring effective infection prevention.

What evidence suggests that this trial's treatments could be effective for pediatric open fractures?

This trial will compare different antibiotic regimens for children with broken bones. Studies have shown that cefazolin, which participants in this trial may receive, effectively treats infections in children with broken bones. Research indicates that cefazolin helps prevent infection after open fractures, where the bone breaks through the skin. In previous studies, cefazolin successfully treated bone infections like osteomyelitis and septic arthritis in children. Cephalexin, another treatment option in this trial, has also proven effective in treating similar infections. Some research has shown that cephalexin can lower the risk of infection in children with certain types of fractures. Overall, both antibiotics have a strong record in preventing and treating infections in children with broken bones. ^{1 3 6 7 8}

Who Is on the Research Team?

Sivashanmugam Raju, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for children and teens (0-17 years old) with immature bones who have a mild to moderate open fracture that happened within the last day. They must be able to take cephalosporin antibiotics, not need surgery for the fracture, and speak English.

Inclusion Criteria

I have a minor to moderate open fracture that occurred within the last day.

Patients under 18 years of age, as determined by radiologic imaging assessed by an orthopaedic doctor.

I am 17 years old or younger.

Exclusion Criteria

Allergies to cephalosporins

You have a severe allergic reaction to penicillin.

Your immune system is weakened or not working properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Within 8 hours of presentation

1 visit (in-person)

Treatment

Participants receive antibiotic treatment based on randomization: one dose of IV cefazolin, 24 hours of IV cefazolin, or 24 hours of IV cefazolin plus 5 days of oral cephalexin

1 to 6 days

In-person during hospital stay

Follow-up

Participants are monitored for infection and adverse events at follow-up appointments or through phone contact

Up to 12 weeks

1 visit at 1 week, then every 1-2 weeks

Extended Follow-up

Study team members check medical records for infection or adverse events, and conduct phone interviews if no follow-up is reported

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cefazolin
• Cephalexin

Trial Overview The study compares infection rates in young patients with open fractures using different antibiotic treatments: one dose of IV cefazolin, 24 hours of IV cefazolin, or 24 hours of IV cefazolin plus 5 days oral cephalexin.

How Is the Trial Designed?

Group I: One dose of IV cefazolin Active Control 1 Intervention

Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.

Group II: 24 hours IV cefazolin Active Control 1 Intervention

Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).

Group III: 24 hours IV cefazolin plus 5 days oral cephalexin Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Published Research Related to This Trial

In a study of 1128 total hip and knee arthroplasties, patients receiving cefazolin had significantly lower rates of surgical site infections (SSIs) compared to those receiving clindamycin or vancomycin (0.9% vs 3.8%).

The use of cefazolin did not result in a higher frequency of interoperative hypersensitivity reactions compared to clindamycin or vancomycin, suggesting it is a safe option for patients labeled as beta-lactam allergic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefazolin vs Second-line Antibiotics for Surgical Site Infection Prevention After Total Joint Arthroplasty Among Patients With a Beta-lactam Allergy. Norvell, MR., Porter, M., Ricco, MH., et al.[2023]

Cefazolin (Ancef) is a first-generation cephalosporin antibiotic commonly used in surgeries to prevent bacterial infections, and it is generally considered safe for most patients.

Despite concerns about cross-reactivity with penicillin allergies, the article aims to investigate the safety of cefazolin for patients with such allergies, suggesting that it may be a viable option rather than using less effective alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Cephalosporins Safe for Surgical Prophylaxis in Patients with Penicillin Allergy? Abraham-Aggarwal, K., Kacker, A.[2023]

Cefotaxime sodium, a third-generation cephalosporin, shows broad antibacterial activity and high resistance to beta-lactamases, making it suitable for various infections.

Quality analysis of 15 cefotaxime sodium products revealed that Claforan had significantly lower particulate contamination and by-products compared to other manufacturers, indicating notable differences in product quality that could impact safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of cefotaxime sodium preparations. Wetterich, U., Mutschler, E.[2016]

In two randomized studies involving 343 patients, cephalexin hydrochloride was found to be as effective as cephalexin monohydrate for treating skin and soft tissue infections, with high response rates of 95.7% and 96.5% respectively.

Both formulations demonstrated a similar safety profile, with only 4.95% of patients experiencing adverse events, indicating that cephalexin hydrochloride is a safe and effective option for these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of cephalexin hydrochloride and cephalexin monohydrate in the treatment of skin and soft tissue infections. Kumar, A., Murray, DL., Hanna, CB., et al.[2021]

Third generation cephalosporins are a safe class of antibiotics with fewer side effects and lower allergenic potential compared to other antibiotics like penicillins and aminoglycosides, making them suitable for use in various healthcare settings.

While generally safe, some third generation cephalosporins can cause specific issues such as hypoprothrombinemia and disulfiram-like reactions, and they may lead to increased diarrhea and risk of drug-resistant bacteria if not monitored properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Third generation cephalosporins: safety profiles after 10 years of clinical use. Neu, HC.[2019]

Recent developments in cephalosporins have led to a variety of new options for clinicians, categorized by their structure and antimicrobial activity, with groups 2 and 4 containing the most therapeutically significant compounds.

Some new broad-spectrum cephalosporins are effective against carbenicillin-resistant strains of Pseudomonas aeruginosa, highlighting their potential in treating difficult infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of cephalosporin antibiotics: microbiological aspects. Knothe, H., Dette, GA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9406608/

Pediatric Open Long-Bone Fracture and Subsequent Deep ... The purpose of the current study was to identify risk factors for deep infection after an open long-bone fracture in pediatric patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06055712

Antibiotic Prophylaxis in Pediatric Open Fractures 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524005881

Antibiotic Considerations in the Management of Pediatric ... Bartlett et al., for the management of Type III tibia fractures, provided a postoperative 3-day course of Cefazolin resulting in a 40% superficial infection ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3935019/

A protocol for the management of pediatric type I open ... The average healing time for the forearm fractures was 50.5 (range 32–84) days. All patients achieved healing of the fracture with satisfactory ...

5. withpower.com withpower.com/trial/phase-4-fractures-bone-8-2023-53a75

Antibiotics for Pediatric Broken Bones · Info for Participants Research shows that cefazolin and cefalexin are effective in treating uncomplicated bone infections in children, like osteomyelitis and septic arthritis, by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080237/

Prehospital Antibiotic Administration for Suspected Open ... The choice of cefazolin 2 g intravenous in the prehospital setting is designed to be safe and rapid and cover potential gram-positive bacteria in suspected open ...

7. mdpi.com mdpi.com/2227-9067/9/8/1243

Pediatric Open Long-Bone Fracture and Subsequent Deep ... Our institutional antibiotic protocol is as follows: Type I or II pediatric open fractures are treated with cefazolin. If allergic to cefazolin, clindamycin is ...

8. chop.edu chop.edu/clinical-pathway/patient-suspected-long-bone-fracture-antibiotic-recommendations

Open Long Bone Fracture Clinical Pathway Antibiotic Recommendations for Open Long Bone Fractures ; Cefazolin, IV. 30 mg/kg/dose every 8 hours; Max: 2,000 mg/dose ; Piperacillin/Tazobactam, IV. 2-9 months.