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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two antibiotic treatments to determine which better prevents infections after emergency trauma surgery. Participants will receive either a combination of cefazolin and metronidazole or ertapenem alone to prevent infections at the surgery site. The trial also employs a tool to predict infection risk in patients. Individuals who recently underwent trauma surgery within 90 minutes of hospital arrival may be suitable for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research has shown that the combination of cefazolin and metronidazole is generally well-tolerated by patients. Patients taking cefazolin have left the hospital about three days earlier, indicating the treatment's safety and effectiveness. This combination is often used to prevent infections during surgery and is considered safe when administered before surgery begins.

Ertapenem is also used to prevent infections during surgery. However, some studies suggest a slightly higher chance of infections after surgery compared to other antibiotics. Despite this, ertapenem effectively prevents infections, especially in surgeries involving the colon.

Overall, both treatments are safe for use in surgeries, though they may differ in effectiveness. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore new approaches for preventing infections after trauma surgery. The combination of cefazolin and metronidazole is unique because it pairs a widely-used antibiotic with another that targets anaerobic bacteria, which could offer more comprehensive protection against diverse bacterial threats. Meanwhile, ertapenem stands out as a broad-spectrum antibiotic that might simplify treatment by covering a wide range of bacteria with a single medication. Both approaches aim to enhance infection prevention in post-surgical patients, potentially leading to quicker recoveries and fewer complications.

What evidence suggests that this trial's treatments could be effective for preventing infections after trauma surgery?

In this trial, participants will receive either a combination of cefazolin and metronidazole or ertapenem alone. Studies have shown that using cefazolin and metronidazole together can significantly reduce infections at surgical sites. One study found that this combination halved the infection rate compared to cefazolin alone. This antibiotic pair also resulted in fewer infections overall and shorter hospital stays. Conversely, research suggests that ertapenem may be less effective, with some findings indicating a higher risk of infections compared to other antibiotics. Overall, cefazolin with metronidazole has demonstrated better results in preventing post-surgical infections. ^{2 6 7 8 9}

Who Is on the Research Team?

Lillian S Kao, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38599478/

Metronidazole and cefazolin vs cefazolin alone for surgical ... The addition of metronidazole to cefazolin before gynecologic surgery decreased the surgical site infection rate by half.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1319016423002955

Antibiotics for preventing infection at the surgical site The present study showed that using a single-dose antimicrobial prophylaxis was equally effective as using multiple doses of antibiotics in decreasing surgical ...

3. tsaco.bmj.com tsaco.bmj.com/content/9/1/e001304

Antibiotic prophylaxis in injury: an American Association for ... No reduction in surgical site infection obtained with post-operative antibiotics in facial fractures, regardless of duration or anatomic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14570343/

Cefazolin versus cefazolin plus metronidazole for antibiotic ... Conclusion: Antibiotic prophylaxis with metronidazole and cefazolin results in fewer postoperative infections, decreased duration of hospitalization, and lower ...

5. researchgate.net researchgate.net/figure/Timing-of-surgical-site-prophylaxis-with-intravenous-cefazolin-and-metronidazole_tbl1_357021931

Timing of surgical site prophylaxis with intravenous ... Primary composite outcome was absence of surgical site infection, venous thromboembolism, postoperative nausea and vomiting, and other in‐hospital postoperative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364272/

The Use of Antibiotics for the Prevention of Surgical Site ... Furthermore, the shortest hospital stay was detected when metronidazole was combined with other antibiotics, in particular with cefazolin in ...

7. withpower.com withpower.com/trial/phase-4-wounds-and-injuries-4-2025-668c9

Antibiotics for Infections After Trauma Surgery ... 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 ...

8. mdpi.com mdpi.com/2079-6382/12/5/908

Six Long-Standing Questions about Antibiotic Prophylaxis ... Cefazolin in particular is safe to administer as a bolus dose immediately before incision. Some parenteral agents, including fluoroquinolones and vancomycin, ...

9. ashp.org ashp.org/surgical-guidelines

Clinical Practice Guidelines for Antimicrobial Prophylaxis in ... 2,3 The guidelines are in- tended to provide practitioners with a standardized approach to the rational, safe, and effective use of antimicrobial agents for the ...