| CTRI Number |
CTRI/2014/09/005063 [Registered on: 25/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
12/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find the Etiology, Epidemiology, Antimicrobial sensitivity and Outcome of Community -Acquired Pneumonia |
|
Scientific Title of Study
|
Etiology, Epidemiology, Antimicrobial sensitivity and Outcome of community acquired pneumonia at Max Super Speciality Hospital, Saket, New Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Yadav |
| Designation |
DNB Resident |
| Affiliation |
Max Healthcare Institute Limited |
| Address |
Max super Specialty hospital
1 press enclave road saket Max super Specialty hospital
1 press enclave road saket South DELHI 110017 India |
| Phone |
9278417385 |
| Fax |
|
| Email |
drhari.yadav@maxhealthcare.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pankaj Soni |
| Designation |
Consultant |
| Affiliation |
Max Healthcare |
| Address |
Max super Specialty hospital
1 press enclave road saket Max super Specialty hospital
1 press enclave road saket South DELHI 110017 India |
| Phone |
9810130673 |
| Fax |
|
| Email |
pankaj.soni@maxhealthcare.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hari Yadav |
| Designation |
DNB Resident |
| Affiliation |
Max Healthcare Institute Limited |
| Address |
Max super Specialty hospital
1 press enclave road saket Max super Specialty hospital
1 press enclave road saket
DELHI 110017 India |
| Phone |
9278417385 |
| Fax |
|
| Email |
drhari.yadav@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Super Specialty Hospital saket |
|
|
Primary Sponsor
|
| Name |
Max Super Specialty Hospital |
| Address |
Dept.of Family Medicine
1 press enclave road saket |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 hari Yadav |
Max Super Specialty Hospital |
Dept of family medicine
1 press enclave road saket South DELHI |
9278417385
drhari.yadav@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max healthcare Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Clinical symptoms like:-
1. Fever (temperature 37.8°C)
2. Production of purulent sputum
3. Cough
4. Leucocytosis (WBC count 10,000/cu.mm)
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
(a) Age >18 years,
(b) Clinical symptoms like:- [5]
1. Fever (temperature >37.8°C)
2. Production of purulent sputum
3. Cough
4. Leucocytosis (WBC count > 10,000/cu.mm)
(c) Radiological evidence of pneumonia without any clinical evidence of pneumonia will also be included.
|
|
| ExclusionCriteria |
| Details |
(a) Hospital acquired pneumonia that is patient hospitalized in the previous 14 days. (b) Known history of HIV-positive status. (c) Known history of tuberculosis. (d) Known history of lung malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it will be measured at the end of study in term of Organism responsible for community acquired pneumonia, epidemiology and their antimicrobial sensitivity. |
Approx 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
07/11/2012 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
After Completing the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim & Objective: To
evaluate the Etiology, Epidemiology, Antimicrobial sensitivity and Outcome of
Community-Acquired Pneumonia (CAP).
Outcome: it will be
measured at the end of study in term of Organism responsible for community
acquired pneumonia, epidemiology and their antimicrobial sensitivity.
Design: Prospective
epidemiologic study, to be done at MAX SUPER SPECIALITY HOSPITAL, SAKET, NEW
DELHI
MATERIAL AND METHODS:-
All adult more than 18 years of
age, between August, 2012 and July, 2013, who will be treated at Max Super
Specialty Hospital (A Unit Of Max Healthcare Institute Limited), Saket, New
Delhi with clinical diagnosis of community acquired pneumonia will be studied
prospectively. It will include the patients that come in as out patients
department or ER or inpatients department and occasionally patient admitted in
other department with other presumptive illness and in whom a diagnosis of CAP
made during the 24 hr of hospitalization
Patient demographic features will
be recorded according to study proforma. A detailed clinical history will be
taken. History for co morbid illness and habits like smoking and alcoholism are
will be taken. Co morbid illnesses were defined as the presence of coexisting
cardiac failure, ischemic heart disease, chronic lung disease (COPD), chronic
liver disease (cirrhosis of liver), chronic kidney disease (diabetic
nephropathy) and diabetes mellitus. A detailed clinical examination will be
carried out including general physical examination, vital signs, and
respiratory system examination, mainly for signs of consolidation and other
systemic examination for the co morbid illness. Routine investigations like
hemoglobin, total leucocytes count, differential count, ESR, random blood
sugar, renal profile, liver function tests, spo2 and paired blood culture will
be recorded. Radiological evaluation inform of chest x ray will be done. Sputum
will be collected for gram stain and culture and sensitivity, other investigation
will be recorded if they are done, are CRP, Procalcitonin and CECT chest.
Outcome of CAP will be measured
in term of in clinical improvement OR lab parameter improvement OR radiological
improvement.
A) Clinical
improvement includes-Body temperature, Pulse rate, Systolic BP, Respiratory
rate and Spo2.
B) Lab
improvement includes-TLC,[CRP and Procalcitonin- if done].
C) Radiological
improvement by comparing day 1st chest x- ray and last chest x- ray available
at the time of discharge in IPD patients and follow up chest x- ray in OPD
patients.
|