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

46 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Cefoxitin for treating appendicitis?

Research shows that Cefoxitin is effective in managing gangrenous and perforated appendicitis, and it helps reduce postoperative infections in patients with ruptured appendicitis. It was also found to be superior to a combination of other antibiotics in preventing intra-abdominal abscesses. ^{1 2 3 4 5}

Is cefoxitin generally safe for use in humans?

Cefoxitin is generally well-tolerated in humans, with studies showing it does not cause serious side effects like nephrotoxicity (kidney damage) or ototoxicity (hearing damage) that are associated with some other antibiotics. Some mild side effects like fever and rash have been reported, but they resolved after stopping the medication. ^{1 2 4 6 7}

How does the drug cefoxitin differ from other treatments for appendicitis?

Cefoxitin is unique because it is a single drug that effectively reduces postoperative infections in appendicitis, especially in preventing intra-abdominal abscesses, compared to combinations like ampicillin and metronidazole. It also has the advantage of not causing nephrotoxicity (kidney damage) or ototoxicity (hearing damage), which can occur with other antibiotic combinations. ^{1 2 5 8 9}

What is the purpose of this trial?

This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. This research will compare the current standard treatment which is a single dose prior to surgery to a new method that includes adding another dose of cefoxitin within 30 minutes of starting the surgery. This study will measure cefoxitin concentrations in blood, fat, and appendix tissue samples to compare the standard dosing method to our new method. This information will help us figure out the right dose of this drug to prevent infection after surgery to remove an appendix.

Research Team

Manjunath Pai, PharmD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Prospective and comparative study of cefoxitin and ceftizoxime in appendicitis surgery]. [2013]

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

Gangrenous and/or perforated appendix: clinical outcome and in vitro susceptibility testing. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Cefmetazole treatment of intra-abdominal infection. [2019]

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

Single-dose cefotetan or cefoxitin versus multiple-dose cefoxitin as prophylaxis in patients undergoing appendectomy for acute nonperforated appendicitis. [2013]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Evaluation of efficacy of cefoxitin in the prevention of abdominal trauma infections. [2013]

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

Prophylaxis in appendicectomy with cefoxitin or ceftriaxone. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Cefoxitin versus gentamicin and metronidazole in prevention of post-appendicectomy sepsis: a randomized, prospective trial. [2019]

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

A randomized prospective study of cefoxitin versus piperacillin in appendicectomy. [2019]