Precision Antibiotic Dosing for Appendectomy

NCT06860802 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: HUM00263447R01HS027788
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appendicitis (Diagnosis)

Keywords

Cefoxitin; Appendectomy; Surgical Site Infections

Outcome Measures

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.

  4 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

The current standard of care surgical prophylaxis regimen

Cefoxitin

EXPERIMENTAL

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

Drug: Cefoxitin

Interventions

Cefoxitin DRUG

Cefoxitin 2000 mg Bolus Injection

Cefoxitin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prisoners
• Patients that are pregnant
• Patients with perforation or abscess on CT Scan

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): collaborator
• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48108, United States

RECRUITING

MeSH Terms

Conditions

Appendicitis; Disease; Surgical Wound Infection

Interventions

Cefoxitin

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Manjunath Pai, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexsas Matvekas, BS

CONTACT

7346470006; matvekas@umich.edu

June Sullivan, MBA

CONTACT

734.615-3488; jusulli@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an interventional phase 1 study design that includes human adult participants undergoing an appendectomy. The study entails collection and analysis of three blood (plasma) samples, two subcutaneous fat samples, and appendix tissue samples from resected surgical specimens. The intervention is to receive the standard of care surgical prophylaxis or the standard of care surgical prophylaxis plus the addition of cefoxitin 2000 mg within 30 minutes of incision

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)