Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308911309456 Date of Approval: 25/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Double J stent: Pathogens and risk factors
Official scientific title Bacterial stent colonization in patients with a double J ureteral stent: Pathogens, risk factors and drug susceptibility
Brief summary describing the background and objectives of the trial To investigate the microorganisms responsible for double j stent colonization and urine infection and the drug susceptibility of the isolates. We also tried to determine factors associated with stent colonization such as indwelling time, sex, age, and comorbidities. Background of the study : In indwelling ureteral stents,bacterial colonization plays an essential role in the pathogenesis of stent-associated infection due to the development of biofilm polysaccharides which is suitable for microorganism’s development and contamination . Patients with indwelling urethral catheters develop asymptomatic urinary tract infection in 5 % to 25 % of the cases while only about 3% to 5% develop symptomatic urinary tract infection requiring antimicrobial drugs or removal of the catheters .
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 155
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group double j stent ablation 5 months A total of 155 patients from our institution were enrolled in this study between January 2023 and Mai 2023. Bladder urine was collected in a sterile container prior to stent removal for bacteriological exam. The removed stents were divided into three parts: top (Renal), middle (Ureteral), and bottom (Bladder); 3 cm pieces from each part were taken and placed in a sterile test tubes for bacteriological investigation. 155
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-All patients with double J stent, in whom the ablation of the stent was preformed during the period of the study -We obtained informed consent from all patients included in the study. -All patients were required an urine bacterial exam at the time of ablation. -Patients with contaminated initial urine bacterial exam -Non-consentient patients. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/06/2023 ETHICS COMMITTEE OF THE UNIVERSITY OF MEDECINE SOUSSE
Ethics Committee Address
Street address City Postal code Country
Av. Mohamed Karoui Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevalence of bacterial colonization of the double J stent Baseline
Primary Outcome Risk factors of the bacterial colonization Baseline
Primary Outcome Microorganisms responsible for double j stent colonization and urine infection Baseline
Secondary Outcome the drug susceptibility of the microorganisms responsible for double j stent colonization and urine infection Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul Hospital Route de la Ceinture Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Hospital Route de la Ceinture Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sahloul Hospital Route de la Ceinture Sousse 4011 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaireddine Bouassida bouassidakhaireddine@gmail.com +21697403480 Route de la Ceinture
City Postal code Country Position/Affiliation
Sousse Tunisia Urology department Sahloul Hospital
Role Name Email Phone Street address
Public Enquiries Hamda Ben Saad bensaadhamda@gmail.com +21655399674 Rue Kairouan
City Postal code Country Position/Affiliation
Sousse Tunisia Urology department Sahloul Hospital
Role Name Email Phone Street address
Scientific Enquiries Manel Marzouk mnmarzouk@gmail.com +21694345678 Rue Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse Tunisia Microbiology department Hached Hospital
Role Name Email Phone Street address
Scientific Enquiries Najd Khalfaoui khalfaouinajd@gmail.com +21623888040 Rue Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse Tunisia Epidemiology department Hached Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide amethodologically sound proposal To achieve aims in the approved proposal Proposal should be directed to bouassidakhaireddine@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information