Antibiotics for Appendicitis
(CASA RELAX Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Steroids, Chemotherapy, Immunosuppressants, Antibiotics
Disqualifiers: Pregnancy, Immunocompromised, Heart failure, Sepsis, Diabetes, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
13467How 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.
568910Eligibility 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
+11 more
Trial 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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Zuckerberg San Francisco General HospitalSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
A randomized comparative study of sulbactam plus ampicillin vs. metronidazole plus cefotaxime in the management of acute appendicitis in children. [2019]Sulbactam is a beta-lactamase inhibitor that, when combined with ampicillin, gives the latter antibiotic a broad spectrum of activity, making it suitable for use as a prophylactic agent in acute appendicitis. In a single-blind, randomized trial, the efficacy of sulbactam plus ampicillin was compared with that of metronidazole plus cefotaxime. Thirty-five children undergoing appendectomy received intravenous sulbactam and ampicillin, while 38 children received metronidazole and cefotaxime. Single doses were given unless the appendix was considered gangrenous or perforated, in which case the drugs were administered for 72 hr. There were three wound infections in the group given sulbactam and ampicillin and five in the group given metronidazole and cefotaxime. The combination of sulbactam and ampicillin was well tolerated and appeared to be at least as effective as that of metronidazole and cefotaxime in the prevention of sepsis following appendectomy.
Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin. [2013]A prospective, controlled trial of antibiotic therapy was carried out in 90 patients with perforated appendicitis. One randomly selected group received systemic metronidazole, started peroperatively, plus locally instilled ampicillin. The other group, also randomly selected, received only local ampicillin. There was no statistically significant difference in the overall frequency of postoperative septic complications (wound infection or intra-abdominal abscess) between the two groups, but wound infections were significantly fewer in the patients given metronidazole. There was no intergroup difference in hospitalization time. Treatment with systemic metronidazole and local ampicillin is recommended in patients operated on for perforated appendicitis.
Amoxycillin/Clavulanic acid monotherapy in complicated paediatric appendicitis: Good enough? [2022]Antibiotic choice for complicated appendicitis should be based on both microbiological effectiveness as well as ease of administration and cost especially in lower resourced settings. Data is limited on comparative morbidity outcomes for antibiotics with similar microbiological spectrum of activity. Incidence and morbidity of surgical site infection after appendectomy for complicated appendicitis was assessed after protocol change from triple antibiotic (ampicillin, gentamycin, and metronidazole) regimen to single agent (amoxycillin/clavulanic acid).
A Danish multicenter study: cefoxitin versus ampicillin + metronidazole in perforated appendicitis. [2019]A prospective controlled randomized-block multicenter study was carried out in 209 patients undergoing surgery for perforated or ruptured appendicitis. The patients received either cefoxitin or ampicillin + metronidazole for 5 days. The treatment was started peroperatively. In both groups wound infections were found to be less than 10 per cent and no difference could be demonstrated. However cefoxitin was significantly superior to ampicillin + metronidazole in preventing intra-abdominal abscesses (P less than 0.05). Cefoxitin offers a single drug treatment that adequately reduces postoperative infectious complications in patients undergoing surgery for perforated or ruptured appendicitis.
[Can acute appendicitis be treated by antibiotics and in what conditions?]. [2009]The current treatment for acute appendicitis is an appendectomy. Several studies have, however, assessed the efficacy of an antibiotic for treating acute appendicitis that is either uncomplicated or complicated by local peritonitis. A meta-analysis in 2007 that collected the results of 44 prospective studies showed that antibiotics were efficacious in 92.8% of cases of appendicitis complicated by local peritonitis, with percutaneous drainage of an abscess when necessary. No predictive factor for failure was identified. The failure of antibiotic treatment did not increase morbidity. Over time and on the whole, the recurrence rate was only 8.9%. The risk of cancer of the appendix (1.5%) nonetheless led to the recommendation of an interval appendectomy for adults. Four randomized controlled trials have compared antibiotic treatment with an appendectomy for the treatment of uncomplicated acute appendicitis. The efficacy of the antibiotic treatment ranged from 86 to 100% and the recurrence rate from 10.4 to 35%. These studies have had various methodological impediments; however, too few patients were included (40 and 80 patients), or only a clinical diagnosis was made before inclusion, or important protocol violations occurred, in particular for almost half the patient in the antibiotic therapy group in the 2009 study. These problems prevent us from relying on these authors' findings. Antibiotics have a role in the initial treatment of acute appendicitis complicated by local peritonitis. In uncomplicated acute appendicitis, the methodological inadequacy of the currently available randomized trials makes it impossible to reach a definitive conclusion about the efficacy of antibiotics.
[Prospective and comparative study of cefoxitin and ceftizoxime in appendicitis surgery]. [2013]Acute appendicitis is the most common acute surgical disease in childhood and it still presents frequent septic complications. This prospective and randomized study compares the efficacy of two cephalosporins (cefoxitin and ceftizoxime) in terms of clinical response, in vitro activity and characteristics of use in clinical practice.
Randomized, prospective, and double-blind trial of new beta-lactams in the treatment of appendicitis. [2021]A prospective, randomized, and double-blind study was conducted with 864 patients operated on for appendicitis. In early cases, including normal and acute appendicitis, one dose of antibiotic was given. The rate of postappendectomy septic complications in patients who received cefotaxime, cefoperazone, or moxalactam was very low (about 3%), and there was no statistical difference between the drugs. For late cases, including gangrenous and perforated appendicitis, the antibiotics were continued for 5 days. Moxalactam decreased significantly the septic complications in these patients when compared with the other two drugs. It is safe, free from serious toxic side effects, and more convenient and easier to administer than combination antibiotic therapy. The main disadvantage of moxalactam is its high cost, but this has to be balanced against the savings in nursing time, the cost of monitoring renal function and serum level when aminoglycosides are used, and the reduced usage and manipulation of infusion sets.
Antimicrobial prophylaxis for appendectomy and colorectal surgery. [2019]Current opinion favors the use of antimicrobial prophylaxis in all operations for acute appendicitis. In clinical trials with placebo controls, the reduction in the rate of postoperative infectious complications is most apparent in perforated and/or gangrenous appendicitis, but benefits are also seen in nonperforated appendicitis and even in those with a normal appendix. In elective colorectal operations, it has been established that all patients should receive prophylactic antibiotics. The choices are an oral bowel preparation consisting of neomycin or kanamycin combined with erythromycin or metronidazole; a parenteral antimicrobial drug such as cefoxitin or cefotetan; or a combined oral/parenteral regimen. Risk factors for postoperative wound infection include a prolonged duration of surgery (greater than 3.5 hours) and rectal resection. The most popular prophylactic regimen employed by American surgeons, particularly in the presence of adverse risk factors, is oral neomycin/erythromycin along with a short course (one to three doses) of a systemic cephalosporin active against anaerobes.
Carbapenems versus ciprofloxacin/metronidazole for decreasing complications and hospital stay following complicated acute appendicitis surgery: A prospective cohort in an Ecuadorian population. [2022]After appendectomy due to complicated acute appendicitis (CAA), there are some alternatives as antibiotic scheme: ciprofloxacin/metronidazole; as well as monoscheme based on carbapenems: ertapenem, meropenem, and imipenem.
Study of appendicitis in children treated with four different antibiotic regimens. [2019]This is a prospective and randomized study of 100 patients with acute appendicitis who were less than 10 years old, in which four different antibiotic regimens commonly in use against gram-negative and anaerobic bacteria were compared in terms of postoperative septic complications. The antibiotics were begun immediately preoperatively and continued for five days. Ten percent of the patients developed infection complications, with 4% requiring further surgery. The best results were obtained with cefoxitin (4% of infection), metronidazole plus amikacin and latamoxef (8%), while the regimen of clindamycin plus amikacin was associated with the greatest number of complications (20%). On analyzing the main microbiologic findings of the study, we conclude that some sort of antibiotic treatment is indicated in all types of appendicitis, due to the occult presence of bacteria in the peritoneal cavity, even without clinical evidence of gangrene or perforation. Further, we emphasize the significance of Streptococcus faecalis as being responsible, along with Escherichia coli and Bacteroides fragilis, for serious postoperative complications.