Precision Antibiotic Dosing for Appendectomy

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About 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 does not accept healthy volunteers

Qualifiers

Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan

Disqualifiers

Prisoners

Patients that are pregnant

Patients with perforation or abscess on CT Scan

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cefoxitin

    Drug

    Cefoxitin 2000 mg Bolus Injection

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: CefoxitinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator