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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05966454
Phase
PHASE4
Status
Recruiting
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Conditions

  • Appendicitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Multiple standard of care antibiotics for appendicitis, at physicians' discretion — DRUG
    Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Study Details

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

Key Dates

Start date
Jun 6, 2023
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Restricted Post-Operative Antibiotics Group
    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.
  • Active Comparator: Liberal Post-Operative Antibiotics Group
    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.

Primary Outcome Measure

Incidence of Infectious/Antibiotic Complications [ Time Frame: Up to 30 days after appendicitis surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Lucy Kornblith, MD
[email protected]
415-206-6946
Lucy Kornblith, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Zuckerberg San Francisco General Hospital· San Francisco, CA

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