FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 

 
Close