| CTRI Number |
CTRI/2021/01/030246 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
04/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of various factors in patients and E. coli bacteria which causes urosepsis in women of reproductive age group. |
|
Scientific Title of Study
|
Evaluation of host and microbial factors that lead to urosepsis in women of reproductive age group: A case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANEENA VARGHESE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF MEDICAL LABORATORY TECHNOLOGY, MANIPAL COLLEGE OF HEALTH PROFESSIONS, MAHE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9526787947 |
| Fax |
|
| Email |
aneena.varghese@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ciraj A M |
| Designation |
Professor of Microbiology |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF MICROBIOLOGY, MELAKA MANIPAL MEDICAL COLLEGE, MAHE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9845170953 |
| Fax |
|
| Email |
ciraj.am@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ANEENA VARGHESE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF MEDICAL LABORATORY TECHNOLOGY, MANIPAL COLLEGE OF HEALTH PROFESSIONS, MAHE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9526787947 |
| Fax |
|
| Email |
aneena.varghese@manipal.edu |
|
|
Source of Monetary or Material Support
|
| MANIPAL ACADEMY OF HIGHER EDUCATION |
|
|
Primary Sponsor
|
| Name |
MANIPAL COLLEGE OF HEALTH PROFESSIONS |
| Address |
DEPARTMENT OF MLT, MCHP, MAHE, MANIPAL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aneena Varghese |
KASTURB HOSPITAL MANIPAL |
Department of Medicine and Department of OBG, KASTURBA MEDICAL COLLEGE, MANIPAL ACADEMY OF HIGHER EDUCATION, MAHE, MANIPAL
Udupi
KARNATAKA |
9526787947
aneena.varghese@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (2) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Urinary and blood isolates of E. coli from women with age ranging from 18 to 49 years attending Kasturba hospital with complaints of UTI or developed UTI after admission to hospital. |
|
| ExclusionCriteria |
| Details |
UTI confirming with microbiological culture with bacteria other than E. coli |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pap, hly A and iut A gene in genetically similar E. coli strains
Serum IgG2 levels in g/L |
4 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification host factors that causes lead to the progression of urosepsis |
4 years |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present case control study is to estimate the host and microbial factors that lead to development of urosepsis in women of reproductive age group having urinary tract infections due to Escherichia coli. The study will be conducted in 85 patients with urinary tract infection and 85 patients with urosepsis visiting/admitted in Kasturba Medical College, Manipal. The primary outcome will be the genetic markers of E. coli causing urosepsis, including pap A, Hly A and iut A along with serum IgG2 levels in ng/ml. |