Precision Antibiotic Dosing for Appendectomy

Conditions

• Appendicitis (Diagnosis)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cefoxitin — DRUG
  Cefoxitin 2000 mg Bolus Injection

Study Details

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.

Key Dates

Start date

Feb 28, 2025

Status verified

Mar 2026

Primary completion

Jun 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

46 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• No Intervention: Standard of Care
  The current standard of care surgical prophylaxis regimen
• Experimental: Cefoxitin
  Administration of Cefoxitin 2000 mg within 30 minutes of incision to the existing standard of care intervention

Primary Outcome Measure

Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue [ Time Frame: 4 hours ]

Central Contacts

• Alexsas Matvekas, BS
  7346470006
  [email protected]
• June Sullivan, MBA
  734.615-3488
  [email protected]

Locations (1)

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