Antibiotics Post-Surgery for Perianal Abscess

(PARFAIT Trial)

Not currently recruiting at 2 trial locations

Overseen By Erin Lillie, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Amoxicillin, Penicillin, Ciprofloxacin, Metronidazole

Disqualifiers: Immunosuppression, IBD, Rectal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether antibiotics, administered after surgery for a perianal abscess (a painful, swollen area near the anus due to infection), can prevent complications like fistulas (abnormal connections between the anal canal and skin). Participants will be divided into three groups: one will receive amoxicillin and clavulanic acid (a combination antibiotic), another will receive ciprofloxacin and metronidazole (another combination of antibiotics), and the last group will not receive antibiotics. The goal is to determine if antibiotics can reduce the need for further treatment and improve recovery. This trial is ideal for adults requiring surgery for a perianal abscess. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have allergies or contraindications to certain antibiotics, or if you have a definite need to be on antibiotics, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the two antibiotic combinations tested in this trial, amoxicillin + clavulanic acid and ciprofloxacin + metronidazole, have been used safely in previous studies.

For amoxicillin + clavulanic acid, studies have found it is generally well-tolerated, with some people experiencing mild side effects like diarrhea. This combination has been safely used after surgeries to prevent infections.

Similarly, ciprofloxacin + metronidazole has been studied for use after surgeries for perianal abscesses. Research suggests this combination is also safe for most people. It has been used to prevent infections, and the side effects are usually mild.

Various studies have tested these antibiotics, showing they are generally safe when used correctly. However, like any medication, they may have side effects. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments being tested for perianal abscesses because they explore different antibiotic combinations that might enhance recovery post-surgery. Unlike the typical standard of care, which often involves a singular antibiotic regimen, this trial investigates combining two antibiotics: amoxicillin with clavulanic acid in one arm and ciprofloxacin with metronidazole in another. These combinations aim to broaden the spectrum of bacterial coverage and potentially reduce infection rates more effectively than single-agent therapies. By testing these combinations against the option of no antibiotics, the trial could reveal more effective strategies for preventing post-surgical infections.

What evidence suggests that this trial's antibiotic treatments could be effective for preventing fistula formation after perianal abscess surgery?

Research has shown that antibiotics can lower the risk of complications after surgery for perianal abscesses. A detailed review found that using antibiotics post-surgery reduced the chance of developing a fistula (an abnormal connection between organs) by 36%. In this trial, participants in the antibiotic 1 arm will receive amoxicillin and clavulanic acid, which studies suggest might prevent fistulas after surgery, with some patients not experiencing recurrence. Participants in the antibiotic 2 arm will receive ciprofloxacin and metronidazole, which have also been studied and show promise in reducing fistula formation. While more evidence is still being collected, antibiotics may significantly help prevent complications after surgery in patients with perianal abscesses. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Karanicolas, MD PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had surgery for a perianal abscess.

Exclusion Criteria

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

I have an abscess due to my IBD.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo incision and drainage of perianal abscess and are randomized to receive either antibiotics or no antibiotics for 7 days

1 week

Follow-up

Participants are monitored for fistula formation, need for re-intervention, and other outcomes over the course of one year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Amoxicillin + Clavulanic Acid
• Ciprofloxacin + Metronidazole

Trial Overview 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.

How Is the Trial Designed?

Group I: Antibiotic 1 arm (amoxicillin + clavulanic acid) Active Control 1 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 Control 1 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 antibiotics Active Control 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study of 90 patients with perforated appendicitis, the combination of systemic metronidazole and local ampicillin significantly reduced the incidence of wound infections compared to local ampicillin alone.

Despite no overall difference in postoperative septic complications or hospitalization time between the two treatment groups, the use of systemic metronidazole is recommended for better wound infection outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin. Schultz, A., Jørgensen, PM., Jørgensen, SP.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10868096/

Efficacy of amoxicillin/clavulanic acid after surgical drainage of ... This clinical trial is designed to evaluate the efficacy and safety of amoxicillin/clavulanic in the prevention of perianal fistula.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38355562/

Efficacy of amoxicillin/clavulanic acid after surgical ... Method: The aim of this study is to evaluate the efficacy of antibiotherapy after surgical drainage of perianal abscess in the development of perianal fistula.

3. researchgate.net researchgate.net/publication/378232992_Efficacy_of_amoxicillinclavulanic_acid_after_surgical_drainage_of_perianal_abscess_in_the_prevention_of_the_development_of_anal_fistula_PERIQxA_study_study_protocol_for_a_multicenter_randomized_double

(PDF) Efficacy of amoxicillin/clavulanic acid after surgical ... The primary outcome measure is the percentage of patients that develop perianal fistula after surgery and during follow-up (6 months).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740125001834

Does antibiotic therapy for anal abscess reduce the risk of ... This study demonstrates that 41 % of patients who underwent incision for a first perianal abscess did not experience recurrence during the follow-up period.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-amoxicillin-and-potassium-clavulanate-for-preventing-anal-fistula-in-patients-after-first-perianal-abscess-surgery/

Study on Amoxicillin and Potassium Clavulanate for ... This study investigates the efficacy of amoxicillin and potassium clavulanate in preventing anal fistula development in patients post-first perianal abscess ...

6. withpower.com withpower.com/trial/phase-3-recurrence-9-2021-70c08

Antibiotics Post-Surgery for Perianal Abscess (PARFAIT Trial) The combination of Amoxicillin + Clavulanic Acid has been used safely in surgeries, with some patients experiencing mild side effects like diarrhea.

7. bmjopen.bmj.com bmjopen.bmj.com/content/12/11/e067970

Antibiotic Treatment foLlowing surgical drAinage of ... The randomised trial by Sözener et al. did not find a protective effect regarding the risk of fistula formation with amoxicillin-clavulanic acid.8 The other ...