Restricted or Liberal Antibiotics After Appendectomy - De... | NCT05002829

NCT05002829

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Restricted Duration of SOC Antibiotic Use
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.	Other: Liberal Duration of SOC Antibiotic Use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restricted Duration of SOC Antibiotic Use	Other	Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.	Restricted Post-Operative Antibiotics Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with no antibiotic related adverse effects	As assessed by treating physician	Up to 40 days after appendicitis surgery
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	As assessed by treating physician	Up to 30 days after appendicitis surgery

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Daniel D Yeh, MD, MHPE	Denver Health and Hospital Authority	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health and Hospital Authority		Denver	Colorado	80204-4507	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25992746	Background	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.
31663966

IPD Sharing Statement Module

Condition Browse Module