| CTRI Number |
CTRI/2024/04/065399 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Treatment Outcomes in Hospital Acquired Superbug Infections. |
|
Scientific Title of Study
|
Antibiotic prescription patterns and outcomes of Hospital acquired Carbapenem Resistant Acinetobacter Baumanii Infections- A prospective observational study. |
| 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 T S Shashikala |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Second Floor OPD Block,
Kasturba Medical College,
Manipal,
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9441383024 |
| Fax |
|
| Email |
drshashikalats@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T S Shashikala |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Second Floor OPD Block,
Kasturba Medical College,
Manipal,
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9441383024 |
| Fax |
|
| Email |
drshashikalats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Shashikala |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Second Floor OPD Block,
Kasturba Medical College,
Manipal,
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9441383024 |
| Fax |
|
| Email |
drshashikalats@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr T S Shashikala |
| Address |
Department of General Medicine, Second Floor OPD Block,
Kasturba Medical College
Manipal, Udupi, Karnataka 576104 |
| 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 T S Shashikala |
Kasturba Hospital, Manipal |
Department Of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9441383024
drshashikalats@gmail.com |
|
|
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: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with culture positive Carbapenem resistant Acinetobacter baumanii infections.
|
|
| ExclusionCriteria |
| Details |
1)Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
2)Pregnancy or breast-feeding.
3)Polymicrobial infections
4)Patients requiring more than 2 weeks of antibiotics (Infective endocarditis, undrainable abscess, or intra-abdominal collections)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality at Day 14 after diagnosis of Hospital Acquired Carbapenem Resistant Acinetobacter Baumanii Infections |
At baseline and at 2 weeks of diagnosis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
22/04/2024 |
| 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="2"
Months="0"
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
|
Justification for the study : Carbapenem resistant Acinetobacter infections are very common in intensive care units in Indian subcontinent leading to high degree of morbidity and mortality. Variety of antibiotic regimens are used in the management of CRAB infections however, the head to head comparison of these antibiotics are not done. We there by propose a prospective observational study to compare the efficacy of commonly used antibiotic combinations in the management of Carbapenem resistant Acinetobacter baumanii infections.
Description : After obtaining Ethical committee clearance and CTRI registration, all the patients with culture positive Carbapenem resistant Acinetobacter baumanii infections meeting the inclusion and exclusion criteria receiving study antibiotics will be recruited from wards and Intensive Care Units of Department of General medicine. Written consent from the patient / patient attenders will be obtained before recruiting the patients in the study. The choice of antibiotics will be decided by treating physician. All the patients recruited in the study will be followed up till 14 days of starting antibiotic and the results will be analyzed. |