| CTRI Number |
CTRI/2024/01/062000 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of 2 antibiotics in treatment of ventilator induced lung infectiopn |
|
Scientific Title of Study
|
comparison of meropenem based triple therapy versus minocycline based triple therapy for treatment of carbapenem resistant acinetobacter baumanii(CRAB) ventilator associated pneumonia - 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 |
Prajapati Jinalben Kishorbhai |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anaesthesiology and critical care , AIIMS Jodhpur , Rajasthan
AIIMS JODHPUR , RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7285833965 |
| Fax |
|
| Email |
jinukprajapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.TANVI M. MESHRAM |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anaesthesiology and critical care , AIIMS Jodhpur , Rajasthan
AIIMS JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9968480167 |
| Fax |
|
| Email |
tanvimeshram162@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajapati Jinalben Kishorbhai |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anaesthesiology and critical care , AIIMS Jodhpur , Rajasthan
AIIMS JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7285833965 |
| Fax |
|
| Email |
jinukprajapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care, AIIMS JODHPUR |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [] |
|
|
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 Jinal Prajapati |
Aiims Jodhpur |
Department of Anaesthesiology and Critical care AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
7285833965
jinukprajapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical sciences,jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J168||Pneumonia due to other specified infectious organisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged >18 years
Patients having CRAB in tracheal aspirate of Ventilator associated pneumonia (VAP) patients according to culture report |
|
| ExclusionCriteria |
| Details |
The patient/relatives who refuse to give informed consent
Age less than 18 years
Pregnant females
Moribund and Brain dead patients
Patients with known allergy to given drug regime |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient treated with minocycline based triple thrapy will have better clinical cure rate and faster microbiological clearance as compared to meropenem based triple therapy |
72 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality rate at 7 & 28 day , length of hospital stay & icu stay will be decreased. |
72 HOURS |
|
|
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)
|
09/02/2024 |
| 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="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is a prospective observatiobal study to study the clinical response , mortality rate at 7and 28 days , length of hospital stay and icu stay , time taken for microbiological eradication in patients having Carbapenem resistant acinetobacter baumanni (CRAB) in tracheal aspirate of Ventilator associated pneumonia patient treated with minocycline versus meropenem based triple therapy. Clinical response will be assessed in terms of temperature resolution ,vasopressor requirement ,nature of bronchial secretion and PaO2/FiO2 ratio. Patient/relatives who refuse to give informed consent, patient of age <18years ,pregnant females ,moribund and brain dead patients and patient having known allergy to given drug regime will be excluded. |