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Antibiotics for Appendicitis

N/A

Recruiting

Led By Rafael Torres Fajardo, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

Study Summary

This trial shows short-course antibiotics are safe, effective, and feasible for treating appendicitis.

Who is the study for?

This trial is for adults over 18 who need an appendectomy and can consent to the study. They must have a way to be contacted post-surgery. It's not for prisoners, those with weakened immune systems, allergies to Bupivacaine, suspected sepsis, uncontrolled diabetes or heart failure, pregnant women, or anyone on antibiotics for other reasons.Check my eligibility

What is being tested?

The CASA RELAX trial is testing if short-course antibiotic treatment after surgery for simple and complicated appendicitis is safe and effective compared to longer treatments.See study design

What are the potential side effects?

Potential side effects from the antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, possible yeast infections due to disruption of normal body flora, and rarely more serious effects such as organ inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with no antibiotic related adverse effects

Secondary outcome measures

Incidence of Infectious/Antibiotic Complications

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention

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

Group II: Restricted Duration of SOC Antibiotic UseExperimental Treatment1 Intervention

Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.

Group III: Liberal Duration of SOC Antibiotic UseExperimental Treatment1 Intervention

Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.

Group IV: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,003,867 Total Patients Enrolled

Rafael Torres Fajardo, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Restricted Post-Operative Antibiotics Group Clinical Trial Eligibility Overview. Trial Name: NCT05746520 — N/A

Appendectomy Research Study Groups: Restricted Post-Operative Antibiotics Group, Restricted Duration of SOC Antibiotic Use, Liberal Post-Operative Antibiotics Group, Liberal Duration of SOC Antibiotic Use

Appendectomy Clinical Trial 2023: Restricted Post-Operative Antibiotics Group Highlights & Side Effects. Trial Name: NCT05746520 — N/A

Restricted Post-Operative Antibiotics Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746520 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project still accepting new participants?

"The information housed on clinicaltrials.gov discloses that this research is not currently recruiting participants. Initially posted in March of 2023 and most recently edited in February of the same year, this trial has ceased recruitment for now; however 28 other studies are actively looking for volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

2023. "Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746520.

All > Appendicitis