Comparative study of three different antibiotic combinations used for the management of acute appendicitis
| ISRCTN | ISRCTN15780064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15780064 |
| Secondary identifying numbers | 0120-583/2019/7 |
- Submission date
- 27/10/2020
- Registration date
- 29/10/2020
- Last edited
- 01/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Appendicitis is inflammation of the appendix (a small pouch connected to the large intestine). It is treated with surgery to remove the appendix. The aims of this study are to identify the microorganisms that cause acute appendicitis, compare the effectiveness and safety of managing acute appendicitis with three different antibiotics that are already used in clinical practice, and study their effect on the microorganisms. The researchers would also like to diagnose acute kidney injury with new biomarkers in urine and blood earlier.
Who can participate?
Participants aged 18 or older with acute appendicitis who are undergoing surgery
What does the study involve?
The study does not change the course of treatment. The researchers will take blood and urine samples and rectal swabs before and after discharge from the hospital.
What are the possible benefits and risks of participating?
During the study patients will not be at a greater health risk. On the contrary, the function of their organs and the level of antibiotics in their blood will be carefully monitored.
Where is the study run from?
University Medical Centre Ljubljana (Slovenia)
When is the study starting and how long is it expected to run for?
August 2020 to April 2024
Who is funding the study?
University Medical Centre Ljubljana (Slovenia)
Who is the main contact?
Nika Obolnar, nika.obolnar@ir-rs.si
Contact information
Scientific
Vrhpolje 60
Kamnik
1240
Slovenia
| Phone | +386 (0)51205622 |
|---|---|
| nika.obolnar@ir-rs.si |
Study information
| Study design | Prospective randomized comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 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 |
| Study objectives | There is no difference between the efficacy and safety of usage of gentamicin+metronidazole, cefuroxime+metronidazole or ertapenem. In a group treated with aminoglycosides, the antimicrobial susceptibility of E. coli isolated from rectal swab before and after treatment is the same, which is the same as other antibiotic regimens. |
| Ethics approval(s) | Approved 24/01/2020, National Medical Ethics Committee of Slovenia (Ministry of Health, Štefanova 5, SI-1000 Ljubljana, Slovenia; +386 (0)1 478 60 01, +386 (0)1 478 69 13; kme.mz@gov.si), ref: 0120-583/2019/7 |
| Health condition(s) or problem(s) studied | Acute appendicitis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gentamicin + metronidazole, cefuroxime + metronidazole, ertapenem |
| Primary outcome measure | 1. Differential blood count (DBC), C-reactive protein (CRP), albumins and markers of renal function (blood urea, creatinine and glomerular filtration rate (GFR)) measured using blood samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 2. Urine specific gravity, pH, proteins, glucose, bilirubin, urobilinogen, white and red blood cells, methylketones, haemoglobin in urine and sediment in urine (white and red blood cells, bacteria and epithelial cells) measured using urine samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 3. E. coli spp. in the rectum measured using rectal swab at baseline and day of discharge 4. Pathological diagnostics using microscopy and sterile instruments as soon as the appendix is safely removed. If the surgery is going to be in the night, then the material will be transferred in the morning. 5. Microbiome studied using 16S rDNA sequencing after the appendix is safely removed and the pathologist has performed the diagnostics |
| Secondary outcome measures | Complications of appendectomy measured clinically after 30 days |
| Overall study start date | 01/08/2020 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 225 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/11/2020 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
Ljubljana
1000
Slovenia
Sponsor information
Hospital/treatment centre
Zaloška cesta 2
Ljubljana
1000
Slovenia
| Phone | +386 (1) 522 50 50 |
|---|---|
| gp.ukc@kclj.si | |
| Website | http://www.kclj.si/ |
"ROR" |
https://ror.org/01nr6fy72 |
Funders
Funder type
Hospital/treatment centre
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Ljubljana, University of Ljubljana Slovenia, University of Ljubljana in Slovenia, Universitas Labacensis, UL
- Location
- Slovenia
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journals. The researchers plan to share raw data as required by the WHO and ICMJE. |
| IPD sharing plan | The data will be published in an article and a PhD thesis, otherwise it will not be made public. |
Editorial Notes
01/09/2023: The following changes have been made and the plain English summary was amended accordingly:
1. The scientific contact was updated.
2. The recruitment end date has been changed from 09/04/2021 to 31/12/2023.
3. The overall study end date has been changed from 09/07/2021 to 30/04/2024.
27/10/2020: Trial's existence confirmed by the National Medical Ethics Committee of Slovenia.
