Antibiotics for Appendicitis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Steroids, Chemotherapy, Immunosuppressants, Antibiotics
Disqualifiers: Pregnancy, Heart failure, Sepsis, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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 if you are currently using antibiotics for other reasons, you cannot participate.
What data supports the effectiveness of the drug for treating appendicitis?
Research shows that antibiotics can be effective for treating uncomplicated appendicitis, with success rates ranging from 86% to 100% in some studies. However, the long-term outcomes and recurrence rates vary, and more research is needed to confirm these findings.
12345Are antibiotics generally safe for humans?
Antibiotics are generally safe for humans, but they can cause side effects like rash, diarrhea, and rare serious complications. They may also affect the heart and cause issues like low blood pressure or changes in heart rate, especially in complex surgical cases. It's important to use them correctly to avoid unnecessary risks.
678910How does the drug treatment for appendicitis differ from other treatments?
The use of antibiotics for appendicitis is unique because it offers a non-surgical option for treating uncomplicated cases, potentially avoiding surgery altogether. This approach is particularly beneficial for patients at high surgical risk, such as those with perforated appendicitis or localized abscesses, where antibiotics can manage the condition effectively.
311121314Eligibility Criteria
This trial is for adults over 18 who need an appendectomy and can consent to the study. They must have a way to be contacted post-surgery. It's not for prisoners, those with weakened immune systems, allergies to Bupivacaine, suspected sepsis, uncontrolled diabetes or heart failure, pregnant women, or anyone on antibiotics for other reasons.Inclusion Criteria
I am 18 years old or older.
Willing and able to provide informed consent
I am scheduled for an appendectomy.
+1 more
Exclusion Criteria
I am suspected to have a severe infection according to the Sepsis-3 criteria.
Prisoners
I am currently taking antibiotics for a condition other than cancer.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive post-operative antibiotics based on the group assignment: restricted or liberal duration
1-4 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up at least 30 days post-appendectomy
4 weeks
1 visit (telephone or electronic medical record review)
Participant Groups
The CASA RELAX trial is testing if short-course antibiotic treatment after surgery for simple and complicated appendicitis is safe and effective compared to longer treatments.
4Treatment 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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.
Group II: Restricted Duration of SOC Antibiotic UseExperimental Treatment1 Intervention
Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.
Group III: Liberal Duration of SOC Antibiotic UseExperimental Treatment1 Intervention
Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.
Group IV: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention
Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
Loading ...
Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
Antibiotic therapy for acute appendicitis in adults. Fewer immediate complications than with surgery, but more subsequent failures. [2018]Appendectomy is the standard treatment for acute appendicitis. Since the 1990s, antibiotic therapy has sometimes been proposed as an alternative to immediate appendectomy. How effective are antibiotics in adults with uncomplicated acute appendicitis, and what is the risk of complications? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology. A systematic review with meta-analysis included four randomised trials of antibiotics versus immediate appendectomy, in 900 patients hospitalised with uncomplicated appendicitis. The studies included only patients with few severe symptoms, thus undermining the strength of the results. Antibiotic therapy was usually administered intravenously first, then orally. The antibiotics used were amoxicillin + clavulanic acid, cefotaxime, or a fluoroquinolone. Metronidazole or tinidazole was often added. The total duration of antibiotic treatment was 8 to 15 days. The overall incidence of complications of appendicitis (perforation, peritonitis and surgical wound infections) was 25% in the immediate appendectomy group versus 18% in the antibiotic group. The frequency of perforations and peritonitis did not differ between the groups. All symptoms of appendicitis disappeared, without relapse or rehospitalisation during the first month, in 78% of patients in the antibiotic group. After one year of follow-up, 63% of patients treated with antibiotics were asymptomatic and had no complications or recurrences. In another systematic review of five randomised trials, outcome at one year was optimal in 73% of patients treated with antibiotics alone versus 97% of patients who had immediate appendectomy. In practice, in early 2014, appendectomy remains the first-line treatment for uncomplicated acute appendicitis. In some still poorly characterised patients, the harm-benefit balance of antibiotic therapy is probably better than that of immediate appendectomy. When informed of the risks, some patients are likely to choose antibiotic therapy.
Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. [2022]Short-term results support antibiotics as an alternative to surgery for treating uncomplicated acute appendicitis, but long-term outcomes are not known.
[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.
Antibiotic therapy versus appendectomy for acute appendicitis: a meta-analysis. [2021]Antibiotic treatment has been shown to be effective in treating selected patients with acute appendicitis, and three randomized controlled trials (RCTs) have compared the efficacy of antibiotic therapy alone with that of surgery for acute appendicitis. The purpose of this meta-analysis of RCTs was to assess the outcomes with these two therapeutic modalities.
The outcome of antibiotic therapy for uncomplicated appendicitis with diameters ≤ 10 mm. [2018]Although many patients receive antibiotic therapy for uncomplicated appendicitis, the relatively high treatment failure and recurrence rates are problematic. We assumed that patients with appendicitis and appendiceal diameters ≤ 10 mm, have better outcomes. The purpose of this prospective non-randomized study was to assess the outcomes of antibiotic therapy in patients with uncomplicated appendicitis and appendiceal diameters ≤ 10 mm.
Unusual effects of common antibiotics. [2019]Antibiotics are widely prescribed and have a generally favorable safety profile. Common adverse effects such as rash and diarrhea are well recognized, but less common ones may go unrecognized. This review highlights rare but potentially lethal complications associated with antibiotics.
Cardiovascular adverse effects of antimicrobials in complex surgical cases. [2007]Previously undescribed adverse effects of antibiotics on the cardiovascular system were described in complex surgical cases. Hypotension, bradycardia and tachycardia were seen in a randomised clinical trial, and confirmed in a randomised experiment with piglets, and in a study with isolated vascular tissue that was exposed simultaneously to antibiotics, endotoxin, and later on histamine at histamine H1-receptors. These findings may influence indications and duration for antimicrobial therapy, and support the concept of "minimal" postoperative antibiotic therapy in emergency abdominal operations.
[Drug therapy of surgical infections. Limits and dangers]. [2006]Antibiotics belong to the most commonly used drugs in surgical practice. Even though they are usually safe adverse reactions and side effects will occur. They can be divided into pharmacologic side effects (impairment of coagulation, ototoxicity, nephrotoxicity), immunologic side effects (immunosuppression, allergic reactions), microbiologic side effects (emergence of resistance, superinfection) and iatrogenic problems. The most commonly made mistakes are antibiotic therapy without clear indication, neglecting pharmacokinetics, unwarranted combination therapy and failure to perform necessary surgical procedures. In order to minimize side effects and errors a limited number of substances should be selected depending on local conditions. Usually, ten antibiotics are sufficient for general surgical practice.
Antibiotic-associated diarrhea. [2019]Diarrhea is clearly one of the most common side effects encountered with antimicrobial treatment. Virtually all drugs with an antibacterial spectrum of activity have been implicated, although there are definite differences in associated incidence rates that appear to depend on spectrum of activity and pharmacokinetic properties. Most cases of antibiotic-associated diarrhea can be classified in two categories: cases in which Clostridium difficile is implicated and cases in which no putative agent or recognized pathophysiological mechanism is clearly established. This review is intended to provide management guidelines for patients with diarrhea that occurs in association with antibacterial agents.
Acute adverse effects of antibiotics. [2018]A review of selected clinical reports in man and experimental studies in lower animals suggests that, under certain circumstances, several commonly used antibiotics may cause cardiovascular depression, respiratory difficulties, or alter the metabolic breakdown of other drugs. These untoward responses are believed to be due to the direct effects of antibiotics on specific physiologic functions, rather than to be related to allergic reactions or cytotoxic lesions. Severe pathologic conditions, over-dosage, or concomitant exposure to other potent drugs may predispose a patient to these acute adverse effects.
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.
[Cost analysis: metronidazole-amikacin vs. preoperative monodose of ceftriaxone in appendicitis. Preliminary report]. [2018]Postoperative management of acute appendicitis in our country has been supported by results from studies overseas. Ampicillin, clindamycin and gentamicin is the classic association of antimicrobial drugs. However, it is expensive, unnecessary and risky. We believe that a single dose can be useful.
[Prospective study on the prevention of wound infections after appendectomy for acute appendicitis]. [2013]In the search for an appropriate antibiotic to reduce the rate of postoperative wound infection in patients with acute appendicitis, we have randomized 150 patients preoperatively in a prospective 3-arm study. The operation technique was standardized for all patients and involved the use of plastic wound protectors. Bacterial contamination was documented by 3 swabs taken during operation. In 2 arms, patients received short-term adjuvant prophylaxis with either cefazolin or clindamycin/tobramycin. The third arm served as a control. Wound contamination ws proven in 33% of all cases but only 4% developed a real wound infection. The rate of infection was almost identical in all groups, without a statistically significant difference in the chi2 test. It is concluded that wound infection after appendectomy cannot be prevented by prophylactic use of antibiotics. Careful operation technique with local protective steps is quite sufficient. Antibiotics should therefore be reserved for special indications.
Treating appendicitis with antibiotics. [2016]A nonsurgical approach using antimicrobial agents has been advocated as the initial treatment of uncomplicated appendicitis. Several studies and meta-analyses explored this approach. Because many of these studies included individuals with resolving appendicitis, their results were biased. Antimicrobials, however, are warranted and needed for the management of surgical high-risk patients with perforated appendicitis and those with localized abscess or phlegmon. Randomized placebo-controlled trials that focus on early identification of complicated acute appendicitis patients needing surgery and that prospectively evaluate the optimal use of antibiotic treatment in patients with uncomplicated acute appendicitis are warranted.