Cefoxitin for Appendicitis

(PANDA Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Michigan

Disqualifiers: Prisoners, Pregnant, Perforation, Abscess

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called cefoxitin (an antibiotic) to prevent infections during appendix removal surgery. Typically, patients receive one dose before surgery, but this study adds an extra dose just before the operation begins. Researchers will collect samples to assess how the extra dose affects drug levels in the body. The goal is to determine the best dosing plan to prevent infections after surgery. Individuals with acute appendicitis planning surgery at the University of Michigan may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.

Do I need to stop taking 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.

Is there any evidence suggesting that cefoxitin is likely to be safe for humans?

Research has shown that cefoxitin is generally safe for people. Studies have found that using antibiotics like cefoxitin before surgery effectively prevents infections in uncomplicated appendicitis cases. This indicates the drug is safe for most people when used in this manner. The FDA has already approved cefoxitin for preventing infections after appendix surgery, which adds confidence in its safety. While researchers test new dosing methods, existing evidence supports its safety in surgical settings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Cefoxitin for appendicitis because it offers a potentially more effective way to prevent infections during surgery. Unlike the standard surgical prophylaxis, which often involves other antibiotics, Cefoxitin is administered at a high dose of 2000 mg just 30 minutes before the incision, aiming for optimal timing and concentration. This strategy could better protect against bacterial infections, enhancing patient outcomes and possibly reducing recovery time.

What evidence suggests that this treatment might be an effective treatment for appendicitis?

Research has shown that cefoxitin reduces infections after appendix surgery. In this trial, some participants will receive cefoxitin as a preventive treatment, which studies have found improves outcomes in straightforward appendicitis cases. When patients receive cefoxitin, the chance of wound infections decreases significantly. This antibiotic also proves effective in more complicated cases, such as when the appendix tissue is dead or has burst. Overall, cefoxitin is a proven choice for preventing infections after appendix surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Manjunath Pai, PharmD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery to remove their appendix due to appendicitis. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

I am diagnosed with acute appendicitis and will have my appendix removed at the University of Michigan.

Exclusion Criteria

Prisoners

Patients that are pregnant

My CT scan shows I have a perforation or an abscess.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard-of-care antibiotics with or without an additional cefoxitin dose during appendectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring antibiotic concentrations in blood, fat, and appendix tissue

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cefoxitin

Trial Overview The study tests cefoxitin dosing methods for preventing infection post-appendectomy. It compares the standard single pre-surgery dose with a new method adding another dose during surgery. Blood, fat, and tissue samples will be analyzed.

How Is the Trial Designed?

Group I: Cefoxitin Experimental Treatment 1 Intervention

Administration of Cefoxitin 2000 mg within 30 minutes of incision to the existing standard of care intervention

Group II: Standard of Care Active Control 1 Intervention

The current standard of care surgical prophylaxis regimen

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

In a study of 209 patients with perforated or ruptured appendicitis, both cefoxitin and ampicillin + metronidazole resulted in wound infection rates of less than 10%, showing similar effectiveness in this regard.

However, cefoxitin was significantly more effective than ampicillin + metronidazole in preventing intra-abdominal abscesses, indicating that cefoxitin is a superior single-drug option for reducing postoperative infections in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Danish multicenter study: cefoxitin versus ampicillin + metronidazole in perforated appendicitis. [2019]

In a study of 288 children with acute appendicitis, both cefoxitin and ceftizoxime showed similar clinical responses and rates of infectious complications, indicating that both antibiotics are effective treatments.

Ceftizoxime, with its longer half-life, offers a practical advantage over cefoxitin, making it a suitable alternative for treating acute appendicitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospective and comparative study of cefoxitin and ceftizoxime in appendicitis surgery]. Sanz Villa, N., Alvarez Bernaldo de Quirós, M., Cortés Gómez, MJ., et al.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41176598/

Evaluating the necessity of post-operative antibiotics in ... Conclusion: Preoperative antibiotics, such as metronidazole and cefoxitin, are sufficient to optimize outcomes in uncomplicated appendicitis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06860802?term=CEFOXITIN&rank=5

Precision Antibiotic Dosing for Appendectomy Primary Outcome Measure: Probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue between intervention and standard care ...

3. journals.lww.com journals.lww.com/annalsofsurgery/abstract/1989/03000/antibiotic_prophylaxis_in_acute_nonperforated.10.aspx

Antibiotic Prophylaxis in Acute Nonperforated Appendicitis The study showed for each group a significant reduction of the incidence of wound infection in patients receiving prophylaxis. However, intra-abdominal abscess ...

4. ashp.org ashp.org/surgical-guidelines

Clinical Practice Guidelines for Antimicrobial Prophylaxis in ... This work represents an update to the previously published ASHP Therapeutic. Guidelines on Antimicrobial Prophylaxis in Surgery,1 as well as guidelines from ...

5. withpower.com withpower.com/trial/phase-1-appendicitis-1-2025-740c5

Cefoxitin for Appendicitis · Info for Participants Research shows that Cefoxitin is effective in managing gangrenous and perforated appendicitis, and it helps reduce postoperative infections in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579393/

Evaluating the necessity of post-operative antibiotics in ... Conclusion. Preoperative antibiotics, such as metronidazole and cefoxitin, are sufficient to optimize outcomes in uncomplicated appendicitis.

7. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2814717

Postoperative Antibiotics, Outcomes, and Resource Use in ... Use of postoperative antibiotics did not improve outcomes in children with nonperforated appendicitis with gangrenous, suppurative, or exudative findings.

8. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-03152-9

Evaluating the necessity of post-operative antibiotics in ... Conclusion. Preoperative antibiotics, such as metronidazole and cefoxitin, are sufficient to optimize outcomes in uncomplicated appendicitis.