A Phase 1 interventional study of Cefoxitin in Appendicitis (Diagnosis), sponsored by University of Michigan. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Michigan · Phase 1, Interventional, and Other
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.
This interventional, phase 1 study aims to improve surgical site infection (SSI) prevention in patients undergoing appendectomy for uncomplicated appendicitis. Despite standard antibiotic prophylaxis, SSI rates remain high, with a pelvic abscess risk of 9.4%. Current prophylactic antibiotic regimens may not achieve optimal tissue concentrations, especially in fat and appendix tissue.
This study will evaluate the probability of target attainment (PTA) of cefoxitin, cefuroxime, and metronidazole in plasma, subcutaneous fat, and appendix tissue. A cohort of 46 adult patients will be randomized to receive standard-of-care antibiotics with or without an additional cefoxitin dose. Antibiotic concentrations will be measured in collected blood, fat, and appendix samples.
The study's primary objective is to determine whether a supplemental cefoxitin dose improves PTA compared to standard prophylaxis. Population pharmacokinetic modeling will validate the intervention's effectiveness in optimizing antibiotic exposure and reducing SSI risk. The results may inform future precision antibiotic dosing strategies for appendectomy and other acute care surgeries.
Primary Outcome Measure:
Probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue between intervention and standard care groups.
Study Design:
Randomized, interventional, phase 1 study Enrollment: 46 participants Inclusion: Adults (>18 years) undergoing appendectomy for acute appendicitis Exclusion: Pregnant individuals, prisoners, patients with perforation or abscess This study seeks to improve perioperative antibiotic management, reducing SSI rates while minimizing unnecessary antibiotic exposure and resistance development.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's planned enrollment of 46 is below the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The current standard of care surgical prophylaxis regimen
Administration of Cefoxitin 2000 mg within 30 minutes of incision to the existing standard of care intervention
Drug: Cefoxitin
Cefoxitin 2000 mg Bolus Injection
Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue
The probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue in the intervention compared to the non-intervention (standard of care) arm.
Time frame: 4 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan