Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Appendicitis Clinical Trial

— CASA RELAX  

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 at Denver Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05002829
• Other study ID #: 20191238
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2275
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis

• 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

• Uncontrolled hyperglycemia or Type 1 Diabetes

• Surgeon preference

• Patient preference

• Research team unavailable

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Restricted Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
• Liberal Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bou Zein Eddine S, Dodgion CM, Qian S, Trevino C, De Moya MA, Yeh DD; EAST Appendicitis Research Group. Complicated Appendicitis: Are Extended Antibiotics Necessary? A Post Hoc Analysis of the EAST Appendicitis "MUSTANG" Study. J Surg Res. 2020 Mar;247:508-513. doi: 10.1016/j.jss.2019.09.054. Epub 2019 Dec 4. — View Citation

Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D, Chuang-Stein C, Cosgrove SE, Fowler VG Jr, Lautenbach E, Chambers HF. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25. Erratum In: Clin Infect Dis. 2023 Jan 6;76(1):182. — View Citation

Lawless RA, Cralley A, Qian S, Vasileiou G, Yeh DD; EAST Appendicitis Study Group. Antibiotics after Simple (Acute) Appendicitis are not Associated with Better Clinical Outcomes: A Post-Hoc Analysis of an EAST Multi-Center Study. Surg Infect (Larchmt). 2021 Jun;22(5):504-508. doi: 10.1089/sur.2019.348. Epub 2020 Sep 3. — View Citation

Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162. Erratum In: N Engl J Med. 2018 Jan 25;:null. — View Citation

Yeh DD, Eid AI, Young KA, Wild J, Kaafarani HMA, Ray-Zack M, Kana'an T, Lawless R, Cralley AL, Crandall M; EAST Appendicitis Study Group. Multicenter Study of the Treatment of Appendicitis in America: Acute, Perforated, and Gangrenous (MUSTANG), an EAST Multicenter Study. Ann Surg. 2021 Mar 1;273(3):548-556. doi: 10.1097/SLA.0000000000003661. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with no antibiotic related adverse effects	As assessed by treating physician	Up to 40 days after appendicitis surgery
Primary	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
Primary	Number of participant deaths	As assessed by treating physician	Up to 30 days after appendicitis surgery