Antibiotics for Perianal Abscess

(RAPID Trial)

MA
Overseen ByMohamad A Abdulhai, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if antibiotics can prevent the formation of fistula-in-ano after incision and drainage of a first time of perianal abscess in adults. A perianal abscess is a collection of infected fluid near the anus. A Fistula-in-ano is an abnormal tunnel that can form between the anal canal and the skin after an abscess.

The main questions it aims to answer are:

Does taking antibiotics after incision and drainage of a perianal abscess lower the chance of developing a Fistula-in-ano? What medical problems or side effects do participants have after taking antibiotics or not taking antibiotics?

Researchers will compare participants who recieve antibiotics after abscess drainage with paticipants who do not recieve antibiotics after abscess drainage, to see if antibiotics lower the chance of developing a Fistula-in-ano.

Participants will:

Be randomly assigned to recieve antibiotics for 7 days after abscess incision and drainage or to not recieve antibiotics after abscess incision and drainage.

Attend follow-up clinic visits after incision and drainage as part of their standard of care.

Complete follow-up phone call about 12 months after incision and drainage. Allow the study team to review their medical record for abscess treatment, symptoms, recurrence, fistula-in-ano formation, additional procedures, and antibiotics side effects.

Are You a Good Fit for This Trial?

This trial is for adults who are having their first perianal abscess treated with incision and drainage. People who have had previous abscesses or fistulas, or certain other medical conditions, may not be eligible.

Inclusion Criteria

English or Spanish speaking patient
Able to provide informed consent
I am 18 years old or older.
See 2 more

Exclusion Criteria

I have had a severe soft tissue infection or Fournier's gangrene.
I have had a perianal abscess in the past 12 months.
Prisoner
See 12 more

What Are the Treatments Tested in This Trial?

Interventions

  • Amoxicillin + Clavulanate
  • Ciprofloxacin + Metronidazole

Trial Overview

The study tests if taking antibiotics (either ciprofloxacin plus metronidazole, or amoxicillin plus clavulanate) for 7 days after surgical drainage of a perianal abscess can prevent the development of an anal fistula compared to not taking antibiotics. Participants are randomly assigned to receive antibiotics or no antibiotics.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Antibiotics after Incision and DrainageExperimental Treatment2 Interventions
Group II: No antibiotics after Incision and DrainageActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+