Cefoxitin for Appendicitis
(PANDA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byManjunath Pai, PharmD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

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.

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.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: CefoxitinExperimental Treatment1 Intervention

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

Group II: Standard of CareActive Control1 Intervention

The current standard of care surgical prophylaxis regimen