Precision Antibiotic Dosing for Appendectomy

NCT ID: NCT06860802

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-09-30

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.

Detailed Description

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.

Conditions

Appendicitis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care

The current standard of care surgical prophylaxis regimen

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cefoxitin

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

Group Type: EXPERIMENTAL

Cefoxitin

Intervention Type: DRUG

Cefoxitin 2000 mg Bolus Injection

Interventions

Cefoxitin

Cefoxitin 2000 mg Bolus Injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Manjunath Prakash Pai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manjunath Pai, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HS027788

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HUM00263447

Identifier Type: -

Identifier Source: org_study_id