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?

This trial aims to determine if taking antibiotics after draining a first-time perianal abscess (a painful, pus-filled bump near the anus) can help prevent a fistula-in-ano (an unwanted tunnel that can form between the anal canal and the skin). Participants will either receive antibiotics (such as Amoxicillin + Clavulanate or Ciprofloxacin + Metronidazole) or no antibiotics after their procedure to evaluate which approach is more effective. The trial will also monitor any side effects from the antibiotics. Suitable candidates have experienced their first perianal abscess requiring drainage and have no history of related conditions like Crohn's disease. As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand its benefits for more patients.

What is the safety track record for these treatments?

A previous study used the combination of amoxicillin and clavulanate effectively in similar medical situations. Most people can handle this combination easily, though some might experience mild side effects like diarrhea or nausea. Another study showed that ciprofloxacin and metronidazole, also used for similar conditions, can be effective but might cause side effects such as a metallic taste in the mouth, nausea, or headaches.

Both antibiotic combinations have seen widespread use in medical practice for other conditions, so doctors understand their safety well. Serious side effects are rare, but patients should pay attention to how they feel and report any unusual symptoms to their healthcare provider.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the potential of using antibiotics like amoxicillin/clavulanate and ciprofloxacin/metronidazole after incision and drainage for perianal abscesses. Unlike the standard of care, which typically involves incision and drainage alone, these antibiotics aim to reduce infection recurrence and speed up recovery. The combination of amoxicillin with clavulanate targets a broad range of bacteria, while ciprofloxacin and metronidazole are used for those with penicillin allergies, offering a tailored approach to patient needs. This treatment strategy is being explored to enhance outcomes and prevent complications, potentially offering a more effective solution for managing this painful condition.

What evidence suggests that antibiotics might be an effective treatment for preventing Fistula-in-ano after perianal abscess drainage?

Research has shown that antibiotics like amoxicillin and clavulanate effectively treat infections and may help prevent complications such as fistula-in-ano after a perianal abscess. In this trial, one group of participants will receive amoxicillin/clavulanate after incision and drainage. Previous studies reported successful outcomes in about 89.6% of patients with similar issues. Participants in this group with a penicillin allergy may receive ciprofloxacin combined with metronidazole instead. Research on this combination indicates these antibiotics can help close fistulas, with success rates ranging from 62% to 83% in some cases. These findings suggest that taking antibiotics after surgery might reduce the risk of developing a fistula by effectively controlling infection.14678

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive antibiotics for 7 days after incision and drainage of a perianal abscess or no antibiotics as part of the randomized controlled trial

1 week
1 visit (in-person) for incision and drainage

Follow-up

Participants are monitored for fistula formation, recurrent abscess, and other outcomes through routine clinical visits and a 12-month follow-up phone call

12 months
Routine clinical visits and 1 follow-up phone call

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+

Citations

A randomized trial of the efficacy and safety of sequential ...

The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus ...

Clinical outcome of extended-spectrum beta-lactamase- ...

In the last 5 to 10 years, the incidence of infections caused by. Enterobacteriaceae producing extended-spectrum beta-lactamase.

A randomized trial of the efficacy and safety of sequential ...

Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = ...

Anal Fistula—Principles of Initial Management: Sepsis Control ...

Anal Fistula—Principles of Initial Management: Sepsis Control, Drainage, and Timing of Definitive Surgery. Authors. Author Affiliations. Megumi Asai.

Systematic review report for question PRP2-5,7

Amoxicillin-clavulanate (19%). Others (3%). Indication for operation: Colorectal cancer (73%); IBD (18%); Other. (9%). Pre-operative radiotherapy: 5%. Type of ...

Infectious Diseases - PMC - NIH

lack of subjective improvement after 72 hours of treatment with amoxicillin indicates treatment failure, at which point the patient should be switched to ...

Risk Factors for Treatment Failure in Neonates With Skin and ...

Treatment failure occurred in 8% (17/202) of neonates receiving oral antibiotics; Neonates with treatment failure had increased odds of having perirectal SSTIs ...

Avoidable Antibiotic Exposure for Uncomplicated Skin and ...

Of 292 total cases where complete prescribing data were available, avoidable antibiotic exposure occurred in 46%.