What is the mechanism of action of this treatment?

The most common treatments for perianal fistulas include antibiotics post-incision and drainage (I&D), surgical drainage, seton placement, and anti-TNF agents. Antibiotics work by preventing infection and reducing inflammation, which helps prevent the formation of fistulas by eliminating the bacteria responsible for abscesses. This is crucial for perianal fistula patients as it reduces the need for further surgical interventions and promotes better healing outcomes. Surgical drainage and seton placement maintain drainage and prevent abscess recurrence, while anti-TNF agents reduce inflammation in cases related to Crohn's disease, aiding in fistula healing.

What side effects are associated with this type of intervention?

The most common treatments for perianal fistulas, particularly those involving post-incision and drainage (I&D) antibiotics, can have several side effects. Surgical intervention may result in pain, bleeding, and infection at the site. Antibiotic therapy, used to prevent infection and fistula formation, can cause gastrointestinal issues like nausea and diarrhea, allergic reactions, and contribute to antibiotic resistance. These potential side effects should be considered when evaluating treatment options.

What prior FDA approvals exist?

The treatment of perianal fistulas often involves the use of antibiotics to prevent infection and fistula formation post-incision and drainage (I&D). Ciprofloxacin and metronidazole are commonly used antibiotics for this purpose. While the context does not specify prior FDA approvals for these antibiotics specifically for perianal fistulas, they are widely used in clinical practice for their effectiveness in preventing complications. Additionally, other treatments for perianal fistulas in Crohn's disease include biologic agents like infliximab and adalimumab, which are FDA-approved for managing fistulizing Crohn's disease.

What other types of research exist?

Promising novel alternatives to antibiotics post-I&D for preventing infection and fistula formation in perianal fistula patients include probiotics, fecal microbiota transplantation (FMT), and anti-inflammatory agents like infliximab. These options have shown potential in other gastrointestinal conditions and may offer benefits in this context, though further research is needed.

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Antibiotics Post-Surgery for Perianal Abscess (PARFAIT Trial)

Q: What other types of research exist?

Promising novel alternatives to antibiotics post-I&#x26;D for preventing infection and fistula formation in perianal fistula patients include probiotics, fecal microbiota transplantation (FMT), and anti-inflammatory agents like infliximab. These options have shown potential in other gastrointestinal conditions and may offer benefits in this context, though further research is needed.

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

Must not have

Allergies or contraindications to amoxicillin + clavulanic acid, penicillin, ciprofloxacin, or metronidazole

Abscess associated with Inflammatory Bowel Disease (IBD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial examines whether antibiotics can prevent complications after treating an infection near the anus in adults. The aim is to determine if antibiotics can stop bacteria from causing additional issues.

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.

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.

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.

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.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to or cannot take certain antibiotics like amoxicillin, penicillin, ciprofloxacin, or metronidazole.

Select...

I have an abscess due to my IBD.

Select...

I have had recurring abscesses near my anus in the last 5 years.

Select...

I have had pelvic radiotherapy in the last 5 years.

Select...

I am not on treatments that weaken my immune system, like steroids or chemotherapy, and I do not have HIV.

Select...

I have an abscess above the pelvic floor muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

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

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for perianal fistulas include antibiotics post-incision and drainage (I&D), surgical drainage, seton placement, and anti-TNF agents. Antibiotics work by preventing infection and reducing inflammation, which helps prevent the formation of fistulas by eliminating the bacteria responsible for abscesses. This is crucial for perianal fistula patients as it reduces the need for further surgical interventions and promotes better healing outcomes. Surgical drainage and seton placement maintain drainage and prevent abscess recurrence, while anti-TNF agents reduce inflammation in cases related to Crohn's disease, aiding in fistula healing.

Does adjuvant antibiotic treatment after drainage of anorectal abscess prevent development of anal fistulas? A randomized, placebo-controlled, double-blind, multicenter study.