Improving antibiotic dosing for appendectomy
Aim 3 - Precision Coordination of Therapeutic and Prophylactic Antibiotics to Reduce Infection, Toxicity, and Emergence of Resistance Following Acute Abdominal Surgery
This test will try whether giving an extra dose of the antibiotic cefoxitin around the start of appendectomy helps adults reach higher antibiotic levels in appendix and fat and reduce surgical infections.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06860802 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 1 trial will enroll 46 adults undergoing appendectomy for uncomplicated acute appendicitis at Michigan Medicine. Participants will be randomized to standard single-dose prophylaxis or to standard prophylaxis plus an additional cefoxitin dose given within 30 minutes of incision. Investigators will measure cefoxitin, cefuroxime, and metronidazole concentrations in plasma, subcutaneous fat, and appendix tissue and compare the probability of target attainment in each group. Population pharmacokinetic modeling will be used to determine whether the supplemental dose improves tissue exposure and could inform precision dosing strategies.
Who should consider this trial
Good fit: Adults (over 18) with uncomplicated acute appendicitis who are scheduled for appendectomy at Michigan Medicine and meet the study's inclusion/exclusion criteria.
Not a fit: Patients with perforation or abscess on CT, pregnant patients, prisoners, or those not having appendectomy at the study site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could lower surgical site infection rates by ensuring better antibiotic levels in appendix and surrounding fat during surgery.
How similar studies have performed: Intraoperative redosing of antibiotics has improved tissue concentrations in other surgical settings, but using a supplemental cefoxitin dose specifically for appendectomy is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan Exclusion Criteria: * Prisoners * Patients that are pregnant * Patients with perforation or abscess on CT Scan
Where this trial is running
Ann Arbor, Michigan
- Michigan Medicine — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Manjunath Pai, PharmD — University of Michigan
- Study coordinator: Alexsas Matvekas, BS
- Email: matvekas@umich.edu
- Phone: 7346470006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.