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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with no antibiotic related adverse effects

Secondary study objectives

Incidence of Infectious/Antibiotic Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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