Antibiotics Post-Surgery for Perianal Abscess

(PARFAIT Trial)

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug combination Amoxicillin + Clavulanic Acid, Ciprofloxacin + Metronidazole for post-surgery treatment of perianal abscess?

Research shows that Amoxicillin + Clavulanic Acid is effective in preventing infections after colorectal surgery, and Metronidazole is effective in reducing infections after appendicitis surgery. These findings suggest that the combination of these drugs could be beneficial in preventing infections after perianal abscess surgery. ^{1 2 3 4 5}

Is the combination of antibiotics like Amoxicillin + Clavulanic Acid and Ciprofloxacin + Metronidazole safe for use in humans?

The combination of Amoxicillin + Clavulanic Acid has been used safely in surgeries, with some patients experiencing mild side effects like diarrhea. Metronidazole, when combined with other antibiotics, has also been used safely in surgeries, showing no significant adverse reactions. ^{1 2 5 6 7}

How does the drug amoxicillin/clavulanic acid differ from other treatments for perianal abscess post-surgery?

Amoxicillin/clavulanic acid is unique because it combines a penicillin-type antibiotic with clavulanic acid, which helps overcome bacterial resistance, making it effective against a broader range of bacteria compared to some other antibiotics. This combination is often easier to use and more cost-effective than other antibiotic regimens, which may require multiple drugs. ^{1 2 6 8 9}

Research Team

Paul Karanicolas, MD PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Amoxycillin and clavulanic acid versus cefotaxime and metronidazole as antibiotic prophylaxis in elective colorectal resectional surgery. [2018]

2. England pubmed.ncbi.nlm.nih.gov

A randomized trial to compare amoxycillin/clavulanate with metronidazole plus gentamicin in prophylaxis in elective colorectal surgery. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Prophylaxis of post-appendicectomy sepsis by metronidazole and ampicillin: a randomized, prospective and double-blind trial. [2019]

4. Sweden pubmed.ncbi.nlm.nih.gov

Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin. [2013]

5. Sweden pubmed.ncbi.nlm.nih.gov

Bactericidal antimicrobial cover in primary suture of perianal or pilonidal abscess. A prospective, randomized, double-blind clinical trial. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of moxalactam with the combination of clindamycin and an aminoglycoside in the treatment of common surgical infections. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Single or multiple doses of metronidazole and ampicillin in elective colorectal surgery. A randomized trial. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Amoxicillin/clavulanic acid versus cefotaxime for antimicrobial prophylaxis in abdominal surgery: a randomized trial. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Antibiotic and clavulanic acid treatment of subcutaneous abscesses caused by Bacteroides fragilis alone or in combination with aerobic bacteria. [2019]