Antibiotic Duration for Appendicitis
(CASA-RELAX Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Louisville
Must not be taking: Steroids, Chemotherapy, Immunosuppressants, Antibiotics
Disqualifiers: Pregnancy, Immunocompromised, Heart failure, Sepsis, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis. For simple appendicitis, patients will be randomized to peri-operative antibiotics or 24 hours duration. For complex appendicitis, patients will be randomized to 24 hours or 4 days duration. Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations.
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 the drug for treating appendicitis?
Research shows that antibiotics can be effective in treating appendicitis, especially when it's complicated by local peritonitis (inflammation of the abdominal lining), with a success rate of 92.8%. However, for uncomplicated cases, the effectiveness varies, and the studies have limitations, making it hard to draw firm conclusions.12345
Is antibiotic treatment for appendicitis safe for humans?
How does the antibiotic duration treatment for appendicitis differ from other treatments?
This treatment is unique because it explores the effectiveness of a shorter course of antibiotics (2-3 days) after surgery for complicated appendicitis, compared to the traditional longer duration (5-7 days). This approach aims to reduce the risk of antibiotic resistance and minimize side effects while maintaining effectiveness in preventing infections.110111213
Eligibility Criteria
This trial is for adults (18+) who are about to have their appendix removed due to appendicitis and can give informed consent. They must have a reliable way to be contacted after leaving the hospital.Inclusion Criteria
I have a working phone or reliable way to be contacted after leaving the hospital.
Willing and able to provide informed consent
I am 18 years old or older.
See 1 more
Exclusion Criteria
I have heart failure.
I have Type 1 Diabetes or my blood sugar levels are very high and hard to control.
I am hospitalized for appendicitis.
See 11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants are randomized to receive either restrictive or liberal post-operative antibiotic therapy based on the complexity of appendicitis
1-4 days
In-hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collected through medical records and a telephone call
4 weeks
1 call (telephone)
Treatment Details
Interventions
- Antibiotic (Antibiotic)
- Antibiotics (Antibiotic)
Trial OverviewThe study is testing if shorter antibiotic treatments work just as well as longer ones after appendix surgery. Patients with simple appendicitis will get either peri-operative antibiotics or a 24-hour dose, while those with complex cases will receive either a 24-hour or a four-day course.
Participant Groups
8Treatment groups
Active Control
Group I: under 65 years simple appendicitis restricted durationActive Control1 Intervention
simple appendicitis restricted duration of no postop antibiotics
Group II: Over 65 complex appendicitis restricted antibiotic durationActive Control1 Intervention
see above for under 65
Group III: Under 65 simple appendicitis liberal durationActive Control1 Intervention
simple appendicitis liberal duration of 24 hours postop antibiotics
Group IV: Under 65 complex appendicitis restricted durationActive Control1 Intervention
complex appendicitis restricted duration of 24 hours postop antibiotics
Group V: Under 65 complex appendicitis liberal durationActive Control1 Intervention
complex appendicitis liberal duration of 4 days of postop antibiotics
Group VI: Over 65 simple appendicitis restricted antibiotic durationActive Control1 Intervention
see above for under 65
Group VII: Over 65 simple appendicitis liberal antibiotic durationActive Control1 Intervention
see above for under 65
Group VIII: Over 65 appendicitis liberal antibiotic durationActive Control1 Intervention
see above for under 65
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Louisville HospitalLouisville, KY
Jewish Hospital ULLouisville, KY
Loading ...
Who Is Running the Clinical Trial?
University of LouisvilleLead Sponsor
References
Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. [2016]Optimal duration of antibiotic treatment to reduce infectious complications after an appendectomy for acute complicated appendicitis remains unclear.
[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.
Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. [2022]Antibiotic treatment after appendicectomy for complicated appendicitis aims to reduce postoperative infections. However, available data on the duration of treatment are limited. This study compared the difference in infectious complications between two protocols, involving either 3 or 5 days of postoperative antibiotic treatment.
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.
The efficacy of postoperative oral antibiotics in appendicitis: a randomized prospective double-blinded study. [2013]The conventional treatment of acute appendicitis is appendectomy followed by intravenous (IV) antibiotics until intraabdominal infection has resolved. It is controversial as to whether it is efficacious to add a course of oral antibiotics after cessation of IV antibiotics. All consenting patients who presented to Kern Medical Center between October 2000 and June 2003 with acute appendicitis were entered into the study. Perforated/gangrenous appendicitis was equally represented in the two study arms. After appendectomy, and when IV antibiotics were ready to be discontinued, patients were randomized to receive a 7-day outpatient course of either placebo (Group 1) or oral antibiotics (Group 2). Patients were monitored for infectious complications for a minimum of 3 months, and there was no statistical difference (11.5% in Group 1 vs 12.1% in Group 2, P = 0.61). The data suggest that adding a course of outpatient oral antibiotics, after completing a course of IV antibiotics, does not decrease postoperative infectious complications in appendicitis patients.
Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis. [2023]Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making.
Long-Term Results Following Antibiotic Treatment of Acute Appendicitis in Adults. [2022]Antibiotic treatment of acute appendicitis has gained interest and inquiries. Reports have demonstrated both safety and high resolution of symptoms and inflammation following antibiotic treatment of appendicitis, but information on long-term results is required. Our present aim was therefore to evaluate long-term recurrence rate of initial antibiotics-alone treatment for suspected acute appendicitis.
Outcomes of Antibiotic Therapy for Uncomplicated Appendicitis in Pregnancy. [2018]The aim of the present study is to determine the feasibility and safety of antibiotics for uncomplicated simple appendicitis in pregnancy.
Non-operative Management for Uncomplicated Appendicitis: An Option to Consider. [2018]The main goal of our study was to assess a 7 days long course of antibiotics for acute uncomplicated appendicitis.
2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial. [2023]The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs.
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial. [2019]Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days.
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.
Perforated appendicitis: Short duration antibiotics are noninferior to traditional long duration antibiotics. [2020]Appendicitis usually manifests as either uncomplicated or complicated disease. Uncomplicated appendicitis is generally treated with an appendectomy without further antibiotic therapy. In contrast, complicated appendicitis can be treated in a myriad of ways. Nonoperative treatment has been proven to be effective but has variable failure rates. Operative management typically involves resection with postoperative antibiotics. The duration of antibiotic therapy is a topic of interest. Past studies have shown that a shorter duration of antibiotics (3-5 days) are equally as effective in treating intra-abdominal contamination. In the fall 2015, our practice pattern for antibiotic duration for acute complicated appendicitis changed to reflect this finding. The purpose of this study is to retrospectively review this change in practice.