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Antibiotics Post-Surgery for Perianal Abscess (PARFAIT Trial)

Phase 3
Waitlist Available
Led By Paul Karanicolas, MD PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Perianal abscess requiring incision and drainage
Patients aged ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

PARFAIT Trial Summary

This trial is designed to study whether giving antibiotics to patients who have had surgery to drain an abscess near their anus can help prevent fistula formation.

Who is the study for?
Adults over 18 with a perianal abscess needing surgical drainage can join this trial. It's not for those allergic to the antibiotics being tested, immunocompromised individuals, recent rectal cancer patients, or those with certain conditions like IBD.Check my eligibility
What is being tested?
The study tests if adding antibiotics (amoxicillin + clavulanic acid or ciprofloxacin + metronidazole) after draining a perianal abscess reduces fistula formation and recurrence. Participants are randomly chosen to receive either standard care with or without antibiotics.See study design
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like diarrhea and nausea, and potential antibiotic resistance. The specific side effects depend on the individual's reaction to amoxicillin + clavulanic acid or ciprofloxacin + metronidazole.

PARFAIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had surgery for a perianal abscess.
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I am 18 years old or older.

PARFAIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimation of fistula formation in three groups
Proportion of complete data collection for patient-reported outcome surveys, across all sites
Proportion of participants who received the allocated intervention, across all sites
+2 more

PARFAIT Trial Design

3Treatment groups
Active Control
Group I: Antibiotic 1 arm (amoxicillin + clavulanic acid)Active Control1 Intervention
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 1 arm will receive a prescription for amoxicillin + clavulanic acid (875 mg amoxicillin and 125 mg clavulanic acid BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.
Group II: Antibiotic 2 arm (ciprofloxacin + metronidazole)Active Control1 Intervention
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 2 arm will receive a prescription for ciprofloxacin + metronidazole (ciprofloxacin 500 mg and metronidazole 500 mg BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.
Group III: No antibioticsActive Control1 Intervention
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. In the comparator arm, patients will not receive any antibiotics. Otherwise, all participants will be treated identically according to the institution's standard practices.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,607 Total Patients Enrolled
Paul Karanicolas, MD PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
5 Previous Clinical Trials
4,280 Total Patients Enrolled

Frequently Asked Questions

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

What types of infections does No packing cavity + antibiotic typically address?

"No packing cavity + antibiotic has demonstrated efficacy in the treatment of cysto-urethritis, otitis externa, lower respiratory tract infection (lrti), and candidal vulvovaginitis."

Answered by AI

Are researchers currently enrolling people for this trial?

"As of right now, this trial has closed recruitment. However, the trial was originally posted on November 18th, 2021. If you are looking for other trials, there are presently 1200 studies actively admitting participants with peri-anal fistulas and 113 trials for No packing cavity + antibiotic actively recruiting patients."

Answered by AI

Has the FDA cleared No packing cavity + antibiotic for use?

"No packing cavity + antibiotic received a safety score of 3 from our Power team. This is because Phase 3 trials have some efficacy data and multiple rounds of safety data."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial
Dr. Paul Karanicolas 2021. "Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549311.
~4 spots leftby Apr 2025
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