Comparative study of three different antibiotic combinations used for the management of acute appendicitis

Prospective randomized comparative study of efficiency and safety of gentamicin with metronidazole, cefuroxime with metronidazole, and ertapenem in the management of community-acquired acute appendicitis in patients who are also treated by surgical management of intra-abdominal infections

Registry ID
ISRCTN15780064
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Ljubljana University Medical Centre
Enrollment
225
Start date
2020-11-09
Completion date
2024-04-30
Last update
2026-08-17

Conditions

Summary

Acute appendicitis

Detailed description

Patients will be treated with surgery as usual, and one of three (combinations of) antibiotics: gentamicin+metronidazole, cefuroxime+metronidazole and ertapenem. After signing an agreement to participate in the study, the researchers will take blood and urine samples and also a rectal swab for identifying E. coli spp. in the rectum. Patients will undergo standard procedures, including transfer to the Department for Abdominal Surgery, where they will receive the first dose of one of three already registered and used antibiotics, and then undergo an appendectomy. During the hospital stay the researchers will take another two blood and urine samples, the last one on the day of discharge from the hospital, when another rectal swab will be taken. The duration of antibiotic therapy is predicted to be short, lasting 4 days depending also on clinical grading of appendicitis and guidelines. After 30 days the researchers will check whether the patient has any complications, including a medical or surgical re-intervention. Urine and blood samples will be examined at the Institute of Clinical Chemistry and Biochemistry. A smaller amount will be stored on ice for further examinations of biomarkers of acute kidney injury. During an appendectomy according to the protocol a part of an appendix is examined by a pathologist for the exclusion of appendiceal malignancy. In this study the tissue will be held at the Institute of Pathology, where the diagnosis will be done. Then a part of the appendix will be further examined by a microbiologist at the Institute of Microbiology and Immunology or Comparative laboratory in the EU, based on scientific collaboration to laboratories. They will study the microbiome of the infected appendix, the patients' DNA material will be destroyed.

Interventions

Inclusion criteria

1. Examined in the ER abdominal surgery department of UCML 2. Adults aged ≥18 years 3. Healthy individuals, no other illnesses 4. Diagnosed with acute appendicitis 5. Indicated for surgery

Exclusion criteria

1. Minors aged <18 years 2. Polymorbid individual 3. Patient with a serious illness 4. Pregnant or breastfeeding women 5. Known renal impairment

Locations

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