Antibiotics for Infections After Trauma Surgery

(PROTECT Trial)

Overseen By Lillian S Kao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Allergy to cephalosporins, prisoners, 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: Unknown

Duration: Immediate post-surgery period

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of the drug Cefazolin for infections after trauma surgery?

Research shows that Cefazolin significantly reduces wound infections in surgeries, such as elective colorectal and hip fracture surgeries, indicating its potential effectiveness in preventing infections after trauma surgery. ^{1 2 3 4 5}

Is ertapenem safe for treating infections?

Ertapenem has been tested in many studies and is generally safe for humans, with most side effects being mild to moderate, such as diarrhea, nausea, and infusion site reactions. Serious side effects are rare, and its safety is similar to other antibiotics like piperacillin-tazobactam and ceftriaxone. ^{6 7 8 9 10}

How does the drug Cefazolin and Ertapenem differ from other treatments for infections after trauma surgery?

Cefazolin and Ertapenem are unique in their use for preventing infections after trauma surgery due to their specific protocols and timing of administration. Ertapenem, in particular, has been shown to significantly reduce surgical site infections when used as a prophylactic measure before trauma laparotomy, highlighting its effectiveness compared to other antibiotics. ^{5 8 11 12 13}

What is the purpose of this trial?

The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables

Research Team

Lillian S Kao, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals who have experienced unintentional home injuries requiring emergency surgery. Participants must be at risk of developing infections after trauma laparotomy, a surgical procedure on the abdomen.

Inclusion Criteria

I had emergency surgery within 90 minutes of arriving at the hospital due to an injury.

Exclusion Criteria

Patients with a known allergy to cephalosporins or β-lactamase inhibitors

Prisoners

I am currently pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ertapenem or a combination of cefazolin and metronidazole to prevent organ space surgical site infections

Immediate post-surgery period

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on organ space surgical site infections

30 days

Treatment Details

Interventions

• Cefazolin
• Ertapenem

Trial Overview The study compares two antibiotic treatments to prevent infections post-surgery: one group receives Ertapenem, and another gets Cefazolin with Metronidazole. The effectiveness against organ space surgical site infections is being measured.

Participant Groups

Group I: Ertapenem only Experimental Treatment 1 Intervention

Group II: Combination of cefazolin and metronidazole. Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Surgical Infection Society

Collaborator

Trials

1

Recruited

140+

Findings from Research

In a double-blind trial involving elective colorectal surgery, prophylactic administration of Cefazolin significantly reduced the incidence of postoperative wound infections from 32% in the control group to 10% in the treated group (P < 0.01).

Patients receiving Cefazolin also experienced a significant reduction in hospital stay by about 3 days (P < 0.05), indicating both safety and efficacy of the antibiotic in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antibiotic prophylaxis in colon surgery with Cefazolin]. Dürig, M., Neff, U., Rittmann, WW., et al.[2013]

Ertapenem, a carbapenem antibiotic, was well tolerated in clinical trials involving 240 healthy volunteers and 2046 patients, with most adverse events being mild to moderate in intensity.

The safety profile of ertapenem was comparable to that of piperacillin-tazobactam and ceftriaxone, with no significant differences in adverse events or safety concerns between elderly and younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of ertapenem. Teppler, H., Gesser, RM., Friedland, IR., et al.[2018]

References

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

Antibiotic prophylaxis in trauma: penetrating abdominal injuries and open fractures. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Perioperative cefazolin prophylaxis in hip fracture surgery. [2013]

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

A randomized controlled trial comparing ceftriaxone with cefazolin for antibiotic prophylaxis in abdominal hysterectomy. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Antibiotic prophylaxis in colon surgery with Cefazolin]. [2013]

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

Prophylactic antibiotics in elective colorectal surgery. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of ertapenem. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Ertapenem: a review of its use in the management of bacterial infections. [2018]

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

Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. [2010]

9. China pubmed.ncbi.nlm.nih.gov

Ertapenem versus ceftriaxone for the treatment of complicated infections: a meta-analysis of randomized controlled trials. [2018]

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

Efficacy and safety of ertapenem versus piperacillin-tazobactam for the treatment of intra-abdominal infections requiring surgical intervention. [2021]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Antimicrobial prophylaxis in colorectal surgery: focus on ertapenem. [2021]

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

Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. [2022]

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

Reduction of Surgical Site Infection After Trauma Laparotomy Through Use of a Specific Protocol for Antibiotic Prophylaxis. [2023]