Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF

NCT05966454 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 21-35457
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (2)

• Incidence of Infectious/Antibiotic Complications

  Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.

  Up to 30 days after appendicitis surgery

• Number of participant deaths

  Up to 30 days after appendicitis surgery

  Up to 30 days after appendicitis surgery

Study Arms (2)

Restricted Post-Operative Antibiotics Group

EXPERIMENTAL

Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Liberal Post-Operative Antibiotics Group

ACTIVE COMPARATOR

Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Interventions

Multiple standard of care antibiotics for appendicitis, at physicians' discretion DRUG

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.

Restricted Post-Operative Antibiotics Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Age ≥ 18 years
• Planned appendectomy (laparoscopic or open)
• Working telephone number or reliable method to contact patient after hospital discharge

You may not qualify if:

• Unable to consent
• Pregnant Women
• Prisoners
• Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
• Heart failure
• Allergy to bupivacaine
• Unlikely to comply with treatment or follow-up
• Inpatient consultation for appendicitis
• Clinically suspected of sepsis based on Sepsis-3 definition
• Current use of antibiotics for other indications
• Type 1 Diabetes or uncontrolled hyperglycemia
• Surgeon preference
• Patient preference
• Research team unavailable

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Lucy Kornblith, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Kornblith, MD

CONTACT

628-206-6946; Lucy.Kornblith@ucsf.edu

Brenda Nunez-Garcia

CONTACT

628-206-6942; Brenda.Nunez-Garcia@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 28, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose

Locations

US (1)