| CTRI Number |
CTRI/2024/09/074256 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of efficacy and safety of ciprofloxacin impregnated catheters in preventing catheter associated urinary tract infections in patients requiring short-term catheterization- An open labelled clinical trial. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of ciprofloxacin impregnated catheters in preventing catheter associated urinary tract infections in patients requiring short-term catheterization-An open labelled clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Parmar |
| Designation |
Postgraduate student |
| Affiliation |
Shri Vasantrao Naik Government Medical College |
| Address |
Department of surgery, Shri Vasantrao Naik Medical College , Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9819019857 |
| Fax |
|
| Email |
parmarkrishna1226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Jatkar |
| Designation |
Dean and Professor |
| Affiliation |
Shri Vasantrao Naik Medical College Yavatmal |
| Address |
Shri Vasantrao Naik Government Medical College , Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822363140 |
| Fax |
|
| Email |
gjatkar9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Jatkar |
| Designation |
Dean and Professor |
| Affiliation |
Shri Vasantrao Naik Medical College Yavatmal |
| Address |
Shri Vasantrao Naik Government Medical College , Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822363140 |
| Fax |
|
| Email |
gjatkar9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vasantrao Naik Government Medical college Yavtamal 445001 |
|
|
Primary Sponsor
|
| Name |
Krishna Parmar |
| Address |
Room no 85 , New HO hostel,Shri Vasantrao Naik Medical College Yavtamal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Parmar |
Shri Vasantrao Naik Medical college Yavatmal |
Department of General Surgery, Shri Vasantrao Naik Government Medical College,Yavatmal 445001
Yavatmal
MAHARASHTRA |
9819019857
parmarkrishna1226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMCYIEC |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ciprofloxacin impregnated foleys catheter |
Ciprofloxacin intravenous solution 200 mg in 100 ml |
| Comparator Agent |
Standard foleys catheter |
Standard foleys catheter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients of age of 18 years or above. 2. Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days. 3.Patients who are willing to participate in the study and give their written informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage. 2. Patients with urinary tract infection at the time of admission. 3.Current antibiotic use or use within 7 days prior to inclusion based on past history. 4. Known allergy to latex, silver salts or hydrogels.5. Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results. 5. Pregnant or breastfeeding woman. 6. Pyschiatric patients 7. Patients with altered consciousness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of catheter associated urinary tract infection in ciprofloxacin impregnated catheter |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Asymptomatic Urinary Tract infection in ciprofloxacin impregnated foleys catheter |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
10/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a randomized controlled open labelled clinical trial for evaluation of efficacy and safety of ciprofloxacin impregnated catheter in preventing catheter associatted urinary tract infection (CAUTI). Catheter will be impregnated in intravenous solution 200 mg in 100ml of ciprofloxacin and used in patients requiring short term catheterisation. Urine routine microscopy and culture will be done on day 3,7,10,21and28. Primary outcome is to compare incidence of CAUTI in ciprofloxacin impregnated foleys catheter and standard foleys catheter. |