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

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT05966454

Collaborator

(none)

145

Enrollment

Location

Arms

24.8

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion	Phase 4

Detailed Description

This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) -A Randomized Controlled Trial

Actual Study Start Date :

Jun 6, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion Standard of Care Antibiotic use will be restricted to none or up to 24 hours of 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.	Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Arm

Intervention/Treatment

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.

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

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of 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.

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

Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Outcome Measures

Primary Outcome Measures

Incidence of Infectious/Antibiotic Complications [Up to 30 days after appendicitis surgery]
Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
Number of participant deaths [Up to 30 days after appendicitis surgery]
Up to 30 days after appendicitis surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Lucy Kornblith, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05966454

Other Study ID Numbers:

21-35457

First Posted:

Jul 28, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Appendicitis

Anti-Bacterial Agents

Antibiotics, Antitubercular

Study Results

No Results Posted as of Jul 28, 2023