| CTRI Number |
CTRI/2022/03/041017 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO ASSESS THE SPECTRUM OF URINARY BACTERIAL ISOLATES AND THEIR ANTIBIOTIC SENSITIVITY AND RESISTANCE PATTERN IN PATIENTS WITH URINARY TRACT INFECTION ADMITTED IN THE INTENSIVE CARE UNIT OF A HOSPITAL |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE SPECTRUM OF URINARY BACTERIAL ISOLATES AND THEIR SENSITIVITY PATTERN IN PATIENTS WITH URINARY TRACT INFECTION ADMITTED IN THE INTENSIVE CARE UNIT OF A TERTIARY CARE HOSPITAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAISTA AHMED |
| Designation |
MSC CLINICAL RESEARCH |
| Affiliation |
JAMIA HAMDARD |
| Address |
Centre for translational science and clinical research floor 3rd,School of chemical and life science,JAMIA HAMDARD
MEHRAULI BADARPUR ROAD
NEW DELHI
South
DELHI
110062
India |
| Phone |
7011336971 |
| Fax |
|
| Email |
Shaistaahmed97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LT GEN AS NARULA |
| Designation |
MD(GEN MED) DM(NEPHROLOGY) |
| Affiliation |
fortis escort heart institute and research centre |
| Address |
FACP DIRECTOR NEPHROLOGY AND TRANSPLANT MEDICINE
FORTIS ESCORTHEART INSTITUTE AND RESEARCH CENTRTE,OKHLA ROAD
NEW DELHI
South West
DELHI
110025
India |
| Phone |
8826199288 |
| Fax |
|
| Email |
narulaas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHD ASHIF KHAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAMIA HAMDARD |
| Address |
CENTRE FOR TRANSLATIONAL SCIENCE AND CLINICAL RESEARCH FLOOR THIRD, SCHOOL OF CHEMICAL AND LIFE SCIENCE,JAMIA HAMDARD
MEHRAULI BADARPUR ROAD
NEW DELHI
South
DELHI
110062
India |
| Phone |
9891026397 |
| Fax |
|
| Email |
makhan@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| FORTIS ESCORTS HEART INSTITUTE OKHLA ROAD,New Delhi 110025 |
|
|
Primary Sponsor
|
| Name |
SHAISTA AHMED |
| Address |
FORTIS ESCORTS HEART INSTITUTE AND RESEARCH CENTRE,ACADEMICS AND RESEARCH DEPARMENTROOM NO 23A, SECOND FLOOR.RESIDENTIAL TOWER,OKHLA ROAD NEW DELHI 1110005 |
| 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 |
| SHAISTA AHMED |
FORTIS ESCORTS HEART INSTITUTE |
FORTIS ESCORTS HEART INSTITUTE OKHLA ROAD NEW DELHI 110025
South
DELHI |
7011336971
Shaistaahmed97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
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
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to ICU diagnosed with UTI and a positive urine culture report with Pyuria. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To define the patterns of bacterial strains isolated in urine cultures of patients admitted in
the ICU setting with UTI
and To define the antibiotic sensitivity patterns of the various bacterial strains of patients admitted in the ICU setting with UTI |
single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine demographic characteristics of patients admitted in the ICU setting with UTI
2. To analyze the potential risk factors associated with UTI in the ICU setting with UTI |
single time point |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The work up for urinary tract infections (UTIs) will include: urinalysis, Gram staining, and urine culture. The mode of collection of urine specimens will be noted: viz supra pubic aspiration, urethral catheterization, or midstream clean catch specimen .The threshold for establishing UTI will include finding 2-5 or more white blood cells (WBCs) or bacteria per high-power field (HPF) in a centrifuged urine sediment.In voided urine specimen, bacterial counts ≥100,000 CFU/mL will be considered diagnostic for a UTI .In catheterized specimens 10000 CFU/mL urines will be considered significant. In supra pubic aspiration specimen any concentration of CFU/mL will be counted as true UTI [6].Bacteriuria without pyuria suggests contamination or colonization and will not be included in the analysis. Organisms, isolated from clinical specimens, will be identified by culture using standard microbiological technique. In patients who are culture positive the demographic data, microrganism grown will be identified and sensitivity patterns of these organism will be seen. After that patient will be assessed on the basis of risk factors which are diabetes mellitus ,hypertension ,indwelling urinary catheter ,duration of ICU stay, Patients on any steroid, duration of antibiotics, coronary heart disease, chronic kidney disease,COPD,cancer,heart failure and surgical intervention. |