145 Participants Needed

Antibiotics for Appendicitis

(CASA RELAX Trial)

LK
BN
Overseen ByBrenda Nunez-Garcia
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those currently using antibiotics for other reasons. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of antibiotics for treating appendicitis?

Research shows that antibiotics can be effective in treating appendicitis, especially when the appendix is perforated or ruptured. For example, a study found that cefoxitin was better than a combination of ampicillin and metronidazole in preventing certain infections after surgery. Another study showed that antibiotics were effective in 92.8% of cases of appendicitis complicated by local peritonitis.12345

Is the antibiotic treatment for appendicitis safe for humans?

The antibiotics used for appendicitis, such as cefoxitin, ampicillin, metronidazole, cefotaxime, and amoxicillin-clavulanate, have been studied and are generally safe for humans. Studies show low rates of complications and no serious toxic side effects, making them well-tolerated options for treating appendicitis.13467

How do antibiotics differ from surgery in treating appendicitis?

Antibiotics offer a non-surgical option for treating appendicitis, especially in cases where the appendix is not ruptured. They can be effective in managing inflammation and infection, potentially avoiding the need for immediate surgery, although there is a risk of recurrence. This approach is different from the traditional treatment of appendectomy, which involves surgically removing the appendix.568910

Research Team

LK

Lucy Kornblith, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 18 with appendicitis who are undergoing an appendectomy and can be contacted post-surgery. Excluded are those with Type 1 Diabetes or uncontrolled sugar levels, immune system issues due to medications or conditions like AIDS, allergies to bupivacaine, heart failure, suspected sepsis, current antibiotic use for other reasons, or if they're unlikely to follow the study plan.

Inclusion Criteria

I am scheduled for an appendectomy.
I am 18 years old or older.
I have a working phone or reliable way to be contacted after leaving the hospital.

Exclusion Criteria

My surgeon has a preferred method for my surgery.
Research team unavailable
Prisoners
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive post-operative antibiotics based on the type of appendicitis: up to 24 hours for complicated cases in the restricted group, and 24 hours to 4 days in the liberal group

1-4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on infectious/antibiotic complications and mortality

4 weeks

Treatment Details

Interventions

  • Multiple standard of care antibiotics for appendicitis
Trial OverviewThe trial is testing whether a short course of various standard antibiotics after surgery is safe and effective for treating simple and complicated appendicitis. The exact antibiotics used are chosen by the doctors involved in the case.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Group II: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

In a randomized trial involving 73 children undergoing appendectomy, the combination of sulbactam and ampicillin was found to be at least as effective as metronidazole and cefotaxime in preventing infections after surgery, with fewer wound infections reported in the sulbactam group (3 vs. 5).
Sulbactam, as a beta-lactamase inhibitor, enhances the effectiveness of ampicillin, making it a suitable and well-tolerated prophylactic option for preventing sepsis in acute appendicitis cases.
A randomized comparative study of sulbactam plus ampicillin vs. metronidazole plus cefotaxime in the management of acute appendicitis in children.Foster, MC., Kapila, L., Morris, DL., et al.[2019]
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.
Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin.Schultz, A., Jørgensen, PM., Jørgensen, SP.[2013]
Switching from a triple antibiotic regimen to a single agent (amoxycillin/clavulanic acid) for treating complicated appendicitis resulted in a higher rate of surgical site infections (22.7% vs. 13.3%), indicating potential safety concerns with the single-agent approach.
Despite the increased rate of surgical site infections with the single agent, overall morbidity measures such as ICU admissions, relook surgery rates, and length of hospital stay were similar between the two antibiotic protocols, suggesting that further research is needed to evaluate the cost-effectiveness and clinical outcomes of single-agent therapy.
Amoxycillin/Clavulanic acid monotherapy in complicated paediatric appendicitis: Good enough?van Coller, R., Arnold, M., le Roux, H., et al.[2022]

References

A randomized comparative study of sulbactam plus ampicillin vs. metronidazole plus cefotaxime in the management of acute appendicitis in children. [2019]
Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin. [2013]
Amoxycillin/Clavulanic acid monotherapy in complicated paediatric appendicitis: Good enough? [2022]
A Danish multicenter study: cefoxitin versus ampicillin + metronidazole in perforated appendicitis. [2019]
[Can acute appendicitis be treated by antibiotics and in what conditions?]. [2009]
[Prospective and comparative study of cefoxitin and ceftizoxime in appendicitis surgery]. [2013]
Randomized, prospective, and double-blind trial of new beta-lactams in the treatment of appendicitis. [2021]
Antimicrobial prophylaxis for appendectomy and colorectal surgery. [2019]
Carbapenems versus ciprofloxacin/metronidazole for decreasing complications and hospital stay following complicated acute appendicitis surgery: A prospective cohort in an Ecuadorian population. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Study of appendicitis in children treated with four different antibiotic regimens. [2019]