| CTRI Number |
CTRI/2024/01/062099 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Klebsiella pneumoniae in respiratory tract infection |
|
Scientific Title of Study
|
Carbapenem Resistant Klebsiella pneumoniae in Respiratory tract infection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navya Shetty |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
2nd Floor, Basic science building ,
Department of Microbiology,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9892877568 |
| Fax |
|
| Email |
shettynavya2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Chawla |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9980220484 |
| Fax |
|
| Email |
kiran.chawla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Navya Shetty |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9892877568 |
| Fax |
|
| Email |
shettynavya2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Navya Shetty |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal |
| 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 Kiran Chawla |
Kasturba Medical College, Manipal |
2nd floor,
Department of Microbiology,
Basic science building , Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9980220484
kiran.chawla@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J150||Pneumonia due to Klebsiella pneumoniae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients whose respiratory samples will be culture positive for Carbapenem Resistant Klebsiella pneumoniae. |
|
| ExclusionCriteria |
| Details |
Pregnant ladies, Children less than 18 years |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Virulence Factor-Biofilm Assay and Serum Assay
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will enhance the knowledge about patient outcome in such infections & the existing
management strategies of these cases in our tertiary care hospital |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Klebsiella pneumoniae is one of the most common Gram-negative, non-motile, encapsulated, lactose-fermenting, facultative anaerobic, rod shaped pathogenic bacterium. The patient population is believed to have impaired respiratory host defences, including persons with diabetes, alcoholism, malignancy, liver disease, chronic obstructive pulmonary diseases, glucocorticoid therapy, kidney failure, and certain occupational exposures (such as papermill workers). Many of these infections are obtained when a person is in the hospital for some or the other reason (a nosocomial infection).They are associated with clinical infections such as pneumonia, urinary tract infection, sepsis, wound infection, and meningitis .The most common condition caused by Klebsiella pneumoniae outside the hospital is pneumonia, typically in the form of bronchopneumonia and also bronchitis. These patients have an increased tendency to develop lung abscess, cavitation, empyema, and pleural adhesions. CRKP was first reported in 1996 and now it is worldwide. CRKP has a death rate around 50%, even with antimicrobial therapy. Carbapenems and other β-lactam antibiotics are the commonly used agents to treat K. pneumoniae infections, and are also last resort drugs for the treatment of multidrug-resistant bacterial infections. With the widespread use of carbapenems, the emergence of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) has been increasingly reported world wide. It is a prevalent clinical concern all over the world that Infection by carbapenem-resistant Klebsiella pneumoniae (CRKP) hampers the treatment of the patients with Respiratory tract infection (RTI). Due to increased virulence and decreased susceptibility to antimicrobials, it is very challenging to treat such patients and it may lead to certain undesired outcomes such as death of patients. Early detection and effective measures are needed to restrict the spread of carbapenamase-producing organisms and optimize antibiotic administration. Since increase number of CRKP infections are being witnessed by medical fraternity, this study will help to bring out the existing occurrence of these pathogens and their existing management strategies in our tertiary care hospital. |