Antibiotics for Pediatric Broken Bones

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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 evidence supports the effectiveness of the drug for treating pediatric broken bones?

Research shows that cefazolin and cefalexin are effective in treating uncomplicated bone infections in children, like osteomyelitis and septic arthritis, by reducing the need for broad-spectrum antibiotics and shortening hospital stays. ^{1 2 3 4 5}

Is cephalexin safe for use in humans?

Cephalexin is generally safe for humans, with common side effects including skin rashes, itching, and mild stomach issues. In studies, only about 5% of patients stopped using it due to side effects. ^{6 7 8 9 10}

How is the drug Cefazolin and Cephalexin unique for treating pediatric broken bones?

This drug combination is unique because it involves starting with intravenous (IV) cefazolin and then switching to oral cephalexin, which has been shown to be effective in reducing the need for broad-spectrum antibiotics and shortening hospital stays in children with bone infections. ^{1 2 11 12 13}

Research Team

Sivashanmugam Raju, MD

Principal Investigator

St. Louis University

Eligibility Criteria

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

I am 18 years old or older.

You have a severe allergic reaction to penicillin.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of guidelines implementation on empiric antibiotic treatment for pediatric uncomplicated osteomyelitis and septic arthritis over a ten-year period: Results of the ELECTRIC study (ostEomyeLitis and sEptiC arThritis tReatment in children). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ampicillin/sulbactam and cefuroxime in the treatment of serious skin and skin structure infections in pediatric patients. UNASYN Pediatric Study Group. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Quality of cefotaxime sodium preparations. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

The current state of cephalosporin antibiotics: microbiological aspects. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Antibiotic restriction programs and cephalosporin use in pediatrics: a survey of infectious disease specialists. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Are Cephalosporins Safe for Surgical Prophylaxis in Patients with Penicillin Allergy? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative study of cephalexin hydrochloride and cephalexin monohydrate in the treatment of skin and soft tissue infections. [2021]

8. United States 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non-inferiority trial. [2019]

10. England pubmed.ncbi.nlm.nih.gov

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

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Use of cephalosporins in pediatric practice with the study of the immunoleukolysis (leukocytolysis) reaction]. [2016]

12. India pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety evaluation of cefaclor VS amoxycillin + calvulanate in children with Acute Otitis Media (AOM). [2019]

13. England pubmed.ncbi.nlm.nih.gov

Continued in vitro cefazolin susceptibility in methicillin-susceptible Staphylococcus aureus. [2018]