| CTRI Number |
CTRI/2023/12/060604 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ROLE OF RAPID SCORE IN PLEURAL INFECTION IN PATIENTS
|
|
Scientific Title of Study
|
A STUDY ON PROGNOSTIC VALUE OF RAPID SCORE IN PLEURAL INFECTION IN PATIENTS
|
| Trial Acronym |
A STUDY ON PROGNOSTIC VALUE OF RAPID SCORE IN PLEURAL INFECTION IN PATIENTS
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annareddy srinivasulareddy |
| Designation |
junior resident |
| Affiliation |
DMIHER |
| Address |
GROUND FLOOR DEPARTMENT OF RESPIRATORY MEDICINE
JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI, MEGHE, WARDHA
GROUND FLOOR DEPARTMENT OF RESPIRATORY MEDICINE
JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI, MEGHE, WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8247637877 |
| Fax |
442001 |
| Email |
annareddymbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR babaji ghewade |
| Designation |
hod of department of respiratory medicine |
| Affiliation |
datta Meghe Institute of Higher Education and Research |
| Address |
Datta meghe institute of higher education and research ,ground floor,Department of respiratorymedicine wardha Maharashtra
Datta meghe institute of higher education and research, ground floor, Department of respiratorymedicine wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822342770 |
| Fax |
|
| Email |
crownbabaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annareddy srinivasulareddy |
| Designation |
junior resident |
| Affiliation |
DMIHER |
| Address |
ground floor department of respiratory medicine
jawaharlal nehru medical college,sawangi,meghe ,wardha
ground floor department of respiratory medicine
jawaharlal nehru medical college,sawangi,meghe ,wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8247637877 |
| Fax |
442001 |
| Email |
annareddymbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| ground floor department of respiratory medicine
jawaharlal nehru medical college,sawangi,meghe ,wardha |
|
|
Primary Sponsor
|
| Name |
DMIHER,JNMC,SAWANGI,WARDHA |
| Address |
DMIHER,JNMC,SAWANGI,WARDHA ,MAHARASHTHRA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DMIHERSAWANGIWARDHA |
DMIHER,SAWANGI,WARDHA ,MAHARASHTHRA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| annareddy srinivasula reddy |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
ground floor department of respiratory medicine
jawaharlal nehru medical college,sawangi,meghe ,wardha
Wardha
MAHARASHTRA |
08247637877
annareddymbbs@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: D860||Sarcoidosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
adult patients both male and female aged 18 years or over with pleural infection. |
|
| ExclusionCriteria |
| Details |
patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of rapid score in pleural infection |
Role of rapid score in pleural infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify factors associated with poor outcomes in patients with pleural infection. |
factors associated with poor outcomes in patients with pleural infection. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/12/2023 |
| 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="3"
Months="0"
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
|
role of prognostic value of rapid score in pleural infections and to identify factors associated with poor outcome in patients with pleural infection. |