Protocol of thesis to be submitted to national board of examinations towards the partial

fulfillment of requirements for the degree of

DIPLOMATE OF NATIONAL BOARD IN GENERAL MEDICINE

TITLE OF THESIS: “Study of C- reactive protein guided antibiotic treatment and duration and
it’s outcome in patients of community acquired pneumonia admitted in Metro hospital and heart
institute gurugram haryana..

By. Guide
Dr. Suresh prajapati Dr. Manoj kumar dutta
D.N.B. resident (General medicine) M.D. MEDICINE
BATCH- 2022-2025 D.N.B ENDOCRINOLOGY
Senior consultant and HOD

Place of study
Metro hospital and heart institute
Gurugram
Under the guidance of
Dr. Manoj kumar dutta
Guide and Head of Department
Department of Medicine
Metro hospital and heart institute
Gurugram haryana
INDEX

Serial.no. Title. Page no.

1. INTRODUCTION 6-7

2. REVIEW OF LITERATURE 8-11

4. REFERENCES 12-13

5. PROFORMA OF THE STUDY 14

6. PATIENT INFORMATION SHEET 15

7. METHODOLOGY AND SAMPLE SIZE 16

8. MISCELLANEOUS 17-23
To
The Executive Director,
National Board of Examinations,
Ansari Nagar,
New delhi,
Through proper channel
Subject: Submission of protocol for thesis entitled “Study of C- reactive protein guided antibiotic
treatment and duration and it’s outcome in patients of community acquired pneumonia admitted
in Metro hospital and heart institute gurugram haryana.”
A hospital based study ”
Sir/Madam,
I am enclosing here the protocol of my thesis on the above cited subject.
Candidate: Dr.Suresh prajapati
DNB (Primary), General Medicine
Institute: Metro hospital and heart institute gurugram haryana ”
Guide: Dr.Manoj kumar dutta
Senior Consultant and Head of Department
MD General Medicine,
Department of General Medicine
Metro hospital and heart institute gurugram Haryana.”
Kindly send the necessary approval for my thesis.
Thanking you,

Your’s sincerely
Dr Suresh prajapati
DATE: 14/02/2023
NATIONAL BOARD OF EXAMINATIONS

NEW DELHI
 PROTOCOL FOR SUBMISSION OF THESIS FOR DEGREE OF DIPLOMATE OF
NATIONAL BOARD

(GENERAL MEDICINE)

Name of candidate: Dr Suresh prajapati

THESIS TOPIC: “Study of C- reactive protein guided antibiotic treatment and duration and it’s
outcome in patients of community acquired pneumonia admitted in Metro hospital and heart
institute gurugram haryana.”

SUBJECT: General medicine

DATE OF JOINING: 05/12/2022

HOSPITAL/ INSTITUTE: Metro hospital and heart institute gurugram haryana.

GUIDE: Dr Manoj kumar dutta

INTRODUCTION

 Community-acquired pneumonia (CAP) is an important cause of mortality and

morbidity worldwide. Aging population, dense urbanization, and poor access
to health care make the Asia-Pacific region vulnerable to CAP. The high
incidence of CAP poses a significant health and economic burden in this
region. Common etiologic agents in other global regions
including Streptococcus pneumoniae, Mycoplasma pneumoniae, Haemophilus
influenzae, Chlamydophila pneumoniae, Staphylococcus aureus, and
respiratory viruses are also the most prevalent pathogens in the Asia-Pacific
region. But the higher incidence of Klebsiella pneumoniae and the presence
of Burkholderia pseudomallei are unique to the region. The high prevalence of
antimicrobial resistance in S. pneumoniae and M. pneumoniae has been
raising the need for more prudent use of antibiotics. Emergence and spread of
community-acquired methicillin-resistant S. aureus deserve attention, while
the risk has not reached significant level yet in cases of CAP. Given a clinical
and socioeconomic importance of CAP, further effort to better understand the
epidemiology and impact of CAP is warranted in the Asia-Pacific region.11

 C-reactive protein (CRP), an acute-phase protein released by hepatocytes

to activate the complement system in response to antigenic and other stimuli,
is a widely available, inexpensive, and highly sensitive marker of the
inflammatory state. Moreover, CRP is not only a marker, but also a driver of
inflammation by human macrophages . In patients with severe CAP, a
significant decrease of in CRP levels at the second day was significantly
associated with decrease 30-day all-cause mortality . Additionally, a failure of
CRP to fall at day 4 leads to an increased risk for 30-day mortality and a need
for mechanical ventilation . CRP levels have been shown to decrease after
successful antibiotic treatment, and serial assessment of CRP aided in the
early identification of CAP patients with poor outcomes. 4 CRP is an acute-
phase protein predominantly produced in the liver. Responding to infection or
tissue inflammation, the production of CRP is rapidly stimulated by cytokines,
particularly interleukin (IL)-6 . These proteins are produced by leucocytes
during inflammation. The healthy individuals have normal level of crp is less
than 0.3 mg/Dl. In moderate inflammation CRP level increases from 1 mg/Dl
to 10 mg/Dl and in severe inflammation it tends to increase greater than 10
mg/Dl.4
CURB-65 severity score12

Method: Score 1 point for each of following features that are present:

Confusion (mental test score 8 new disorientation in person, place or time)

BUN > 20 mg/dL

Respiratory rate 30 breaths/min

Blood pressure (systolic <90 mm Hg, or diastolic 60 mm Hg)

Age 65 years

 Interpretation of CURB-65 score:

0-1: Probably suitable for home treatment; low risk of death

2: Consider hospital supervised treatment

3: Manage in hospital as severe pneumonia; high risk of death

REVIEW OF LITERATURE
1. R P Smith conducted a retrospective case note review study which included 40 patients
admitted with simple community acquired pneumonia and 20 patients with purulent
bronchitis . Serum CRP levels, were measured in admitted patients on day one. In 22
cases of CAP, a second sample taken after 3 to 7 days of antibiotic treatment.
Temperature & leukocytes count shows significant overlap between the CAP and
chronic bronchitis patient but there was no significance in serum CRP. C-reactive
protein levels >100 mg/L in all cases of CAP except 2 cases. In the bronchitic patient’s
only 7 out of 20 had levels >10 mg/L . A CRP > 70 mg/L in CAP on 1 st day occurred in
association with leucocyte count less than 12×109/L in 45% of cases and with a temp.
<37.0°C in 32% patients . CRP levels fall to <100 mg/L in all patients of CAP to after
antibiotic tharepy.

2. Luis Coelho conduct cohort study on 53 community acquired pneumonia b/w nov.2001
to dec. 2002 in ICU pts. In pGarcia de orta hospital. daily marker emphysema body
temp, TLC . Decrease CRP level on 3rd day from previous day levels marker of good
prognosis. Daily CRP measurement useful in the identification of early outcome in
severe community acquired pneumonia and patients with low outcome. C reactive
protein measurement better than other infection markers like temperature and total
leukocyte and better correlation with clinical progression checking by sofa score.

3. Mona bafadhel conduct a prospective study between 2006 to 2008 in two hospitals in
England patient of CAP & COPD which age between 18 to 93 year. 62 patients with
CAP , 161 patient with COPD, 96 pts with asthama were studied. Patient have higher
CRP & PCT levels in case of CAP then COPD and ASTHAMA patients. This two marker
also differentiated between acute acceleration of asthma and community acquired
pneumonia . This study suggest that CRP & PCT good guide of antibiotic therapy in
community acquired pneumonia and reduce antibiotic overuse in acute respiratory
illness like asthama & COPD. There are less requirement of aggressive antibiotic therapy
in asthma and COPD like respiratory illness.
4. Elodie von dach conduct clinical trial b/w April 2017 to may 2019 to compare clinical
effectiveness of CRP guided antibiotic therapy with respective of different duration
among 504 patients. Among these patients gram negative septisemia 30 day antibiotic
therapy guided with CRP and fixed 7 day antibiotic therapy have difference to fixed 14
day antibiotic treatment. CRP guided group have large margin of difference with low
observed event rate low adherence and give wide range of antibiotic treatment
duration. This is study shows overuse of antibiotic and antibiotic resistance & results in
gram negative septisemia.

5. A.H.W.Bruns conduct a study prospective randomized control trial at multicentre with

retrospective analysis of collected data from this study. This study shows relationship
between regular CRP measurement with followup antibiotic treatment in patient of
severe CAP . CRP measurement done on day 3 days 7 and day 28 . 137 out of 289
severe CAP patients etiology determined . Study shows that CRP fall less than 60% on
day 3 and less than 90% CRP fall on day 7 compare to initial level of CRP , that shows
patient receive inappropriate antibiotic treatment, but in 122 patients out of 289
patients receive appropriate antibiotic treatment and show greater than 60% fall of CRP
level on day 3 and greater than 90% on day 7. A delayed fall of CRP shows in
inappropriate antibiotic treatment and higher risk.

6. Josselin Le Bel conduct a prospective study on 200 suspected patients of CAP at multiple
centre for check the sensitivity and specificity to diagnosis of CAP with serum
CRP ,serum PCT and systemic ct scan of chest. 200 patients divide into 3 groups (a) 98
definitive CAP ,(b) 8 as probable, (c) 23 as possible (d) 71 excluded (29 patient with pul.
Infiltrates on chest X ray) study found results that biomarkers can’t differentiate
bacterial CAP from viral CAP. If we exclude the definitive viral CAP in this study
 diagnostic accuracy remains same not increase. Biomarkers diagnostic accuracy are low
compared to gold standard test like thoracic CT scan.

7. R. Zalacain conduct a study in multicentre on elderly patients greater than 65 year from
jan. 1 /1997 to dec. 31/1997 whose admitted in hospital due to CAP it included 503 pts
age group 69 to 83 yrs. CAP is more comman in elderly population due progressive
ageing. Clinical features includes cough ,fever, expectoration, dyspnea, pleuritic pain,
altered mental status , leukocytosis. Main infective agents are is streptococcus
pneumonia and H.influenza . 53 patients out of 503 died due to multiple bad prognostic
factors like history of previous hosptilisation , creatinine in greater than 1.4 milligram/dl,
oxygen saturation low at hospital admission, abnormal vital signs(temp. <36.1°C ,HR
>110bpm and SBP<90mmHg ) age>85 yr ,shock and renel failure during clinical course.
Out of these altered mental status and higher plasma creatinine level associated with
greater mortality rates.

8. Aopstolos Travlos a prospective study in Athens university department of pulmonary

medicine from Jan 2013 to sept 2019. Total 173 CAP patients out of 194 patient taken
for study after exclution criteria applied. After diagnosis of CAP antibiotic therapy is
started . CRP serial measurements are taken on Day 1 , Day 3 and day 7 . patient follow
up till day 30 from diagnosis of CAP on day one that patients called as survivors and who
died before day 30 called non Survivor. Than compare the CRP values of day4 to day1
and day7 CRP value with day 1 and day 4 values. Decline in CRP value greater than 50%
from day1 to day 4 have shorter duration of hospitalisation and who have decline in CRP
value greater than 50% from day 4 to days 7 have few days and and hostaliSation.
CURB 65 don’t have any relation hospitalization stay duration.
9. James D. Chalmers conduct a prospective study on 570 patients of cap over the two year
duration.C-reactive protein synthesized in liver due to response of interleukin 6. CRP
measured on day 1 on admission and day four. In community acquired pneumonia
moratility depends upon needs of mechanical ventilation, inotropic support , and
complications of pneumonia like pulmonary abceses, emphysema, pulmonary effusion.
Patients who have low CRP level at bn time admission found low 30 day moratility rate .
This study show 30 day moratility rate 9.6%. patient patients who have CRP level failure
to fall >50% after day 4 compared to admission day 1 CRP levels have higher 30 day
mortality rates and have more prone to require mechanical ventilation or inotropic
supports and complicated pneumonia.

10. Isabela Borges conduct a randomised control trial of clinical and C-reactivs protein
based protocol versus evidence based practice strategy without markers on 130 patient
of community acquired pneumonia . Divide into two groups CRP and CONTROL. Median
duration of antibiotic therapy 7 (5 – 8.8) days for CRP group and CONTROL group 7 ( 7 -
11.3) days . This is studies shows that Daily CRP level monitoring allow early antibiotic
reduction and majority of patient without decrease total antibiotic uses. Antibiotic total
duration reduce by CRP guided therapy. Sepsis related Mortality rate similar in both CRP
and CONTROL groups .Mortality rate in CRP guided antibiotic suspension dose
reduction therapy group as control group where antibiotic given by without any
biological markers.
 LACUNA IN LITERATURE

1. Previous studies regarding C- reactive protein guided antibiotic treatment and

duration and its outcome in patients of community acquired pneumonia have
failed to cover all lacunae.

2. Previous studies regarding C- reactive protein guided antibiotic treatment and

duration and its outcome in patients of community acquired pneumonia has given
less information about average duration of antibiotics use for CRP levels
normalization and tapering of dose of antibiotics and also reduce number of
antibiotics according to consecutive CRP levels.
REFERENCES

1. Robin P.SmithMRCP (UK)aBrian J.LipworthFRCP (Edin), MDa C-Reactive Protein in Simple

Community-Acquired Pneumonia.

2. Luís Coelho, Pedro Póvoa, Eduardo Almeida, Antero Fernandes, Rui Mealha, Pedro
Moreira and Henrique Sabino. Usefulness of C-reactive protein in monitoring the severe
community-acquired pneumonia clinical course.

3. Mona Bafadhel , MBChB ; Tristan W. Clark , BM ; Carlene Reid, BSc; Marie-jo Medina,
MS; Sally Batham, RGN, BA ; Michael R. Barer, PhD; Karl G. Nicholson, MD;
and Christopher E. Brightling, PhD, FCCP Procalcitonin and C-Reactive Protein
in Hospitalized Adult Patients With Community-Acquired Pneumonia or
Exacerbation of Asthma or COPD.

4. Elodie von Dach, PhD1,2; Werner C. Albrich, MD3; Anne-Sophie Brunel, MD4; et al
Protein–GuidedAntibioticTreatmentDuration,7-DayTreatment,or14-DayTreatmenton30-
 DayClinicalFailureRateinPatientsWithUncomplicatedGram-
NegativeBacteremiaARandomizedClinicalTriaL.

5. A.H.W. Bruns*, J.J. Oosterheert*, E. Hak#," and A.I.M. Hoepelman* Usefulness of

consecutive C-reactive protein measurements in follow-up of severe community-
acquired pneumonia.

6. Josselin Le Bel1,2*, Pierre Hausfater3,4, Camille Chenevier-Gobeaux5, François-Xavier

Blanc6,7, Mikhael Benjoar8, Cécile Ficko9, Patrick Ray10, Christophe Choquet11, Xavier
Duval2,12,13†, Yann-Erick Claessens14†.

7. R. Zalacain*, A. Torres#, R. Celis#, J. Blanquer}, J. Aspaz, L. Esteban§, R. Mene´ndezƒ, R.

Blanquer**, L. Borderı´as##, on behalf of the "Pneumonia in the elderly" working group,
Area de Tuberculosis e Infecciones Respiratorias. Community-acquired pneumonia in
the elderly: Spanish multicentre study.

8. Apostolos Travlos, Agamemnon Bakakos , Konstantinos F. Vlachos, Nikoletta Rovina ,

Nikolaos Koulouris and Petros Bakakos. Article C-Reactive Protein as a Predictor of
Survival and Length of Hospital Stay in Community-Acquired Pneumonia.

9. James D. Chalmers MBChB, MRCP(UK),Aran Singanaygam MBChB, AdamT. Hill MD,

FRCPE C-reactive protein is an independent predictor of severity in community-acquired
Pneumonia.

10. Isabela Borges1,2* , Rafael Carneiro1, Rafael Bergo1, Larissa Martins3, Enrico
Colosimo3, Carolina Oliveira4, Saulo Saturnino4, Marcus Vinícius Andrade4, Cecilia
Ravetti1, Vandack Nobre1, on behalf of NIIMI– Núcleo Interdisciplinar de Investigação
em Medicina Intensiva. Duration of antibiotic therapy in critically ill patients: a
randomized controlled trial of a clinical and C-reactive protein-based protocol versus an
evidence-based best practice strategy without biomarkers.

11. Jae-Hoon Song, MD, PhD,1,2 Kyungmin Huh, MD, MSc,3 and Doo Ryeon Chung, MD, PhD1,2
Community-Acquired Pneumonia in the Asia-Pacific Region

12. Lim WS, van der Eerden MM, Laing R, Boersma WG, Karalus N, Town GI, et al. Defining
community acquired pneumonia severity on presentation to hospital: an international
derivation and validation study. Thorax 2003;58:377-82

13. Vandana Kalwaje Eshwara,1 Chiranjay Mukhopadhyay,1 and Jordi Rello2,3 Community-
acquired bacterial pneumonia in adults: An update
PROFORMA OF THE STUDY—

1. Name:

2. Age/Sex:

3. IP No.:

4. Address:

PRESENTING COMPLAINT HISTORY—

EXAMINATION—

1.General Physical

2.Systemic Examination—

INVESTIGATION—

1. CBC
 2. Serum CRP level
3. ESR
4. SPUTUM- Gram stain/AFB/Culture
5. Blood culture
6. LFT/KFT/Urine routine
7. Chest X-ray PAVIEW,
8. HRCT CHEST
9. ABG,
10. ECG
11.Procalcitonin
12. NT Pro BNP

PATIENT INFORMATION SHEET

Patient Name : Age/Sex OPD/IPDNO.

Unit:

Date of admission:

You are being invited to participate in a research study. Before you participate in this research
study, we would like to explain the study to you and give you a chance to ask questions. Please
carefully read the information provided here. If you agree to participate, kindly sign the informed
consent form.
Protocol Title: “Effect of C reactive protein guided antibiotic treatment and duration of outcome
admitted patients of community acquired pneumonia admitted in metro hospital and heart
centre Gurugram Haryana
Introduction : Our study will assess your blood investigations,, symptoms of cough with or
without sputum,chest pain,breathing difficulty associated with or without exertion or in resting
condition,fever. You have chosen because you fulfilling the inclusion criteria. This not an
interventional study so it does not have any relative injury. Therefore you will not be provided
any kind of monetary incentives. However, any inference we draw from this study will help us
treat you and our society in a better way and you will have the satisfaction of serving mankind.
Confidentiality : Your participation in this research study will kept entirely confidential and your
name will not be mentioned in the data published. You have the right to leave the study in
between and it will not affect your or your family treatment from hospital.

If you have any quaries then contact —

Dr. Suresh Prajapati

(PH: 7987926416 )

Dept.of Medicine

Metro Hospital and Heart Institute,Gurugram Haryana .

Participant’s Consent Form

प्रतिभागी सहमति पत्र
Participant’s Name/ प्रतिभागी का नाम-
Age/Sex- आयु/लिंग-
Date/ दिनांक-
Address /पता-
Name of principal investigator:: Dr. Suresh prajapati

Title of the project (परियोजना का शीर्षक) –“Study of C- reactive protein guided antibiotic treatment
and duration and it’s outcome in patients of community acquired pneumonia admitted in Metro
hospital and heart institute gurugram Haryana.
The details of the study have been provided to me in writing and explained to me in my own
language. I confirm that I have understood the above study and had the opportunity to ask
questions. I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without giving any reason, without the medical care that will normally be
provided by the hospital being affected. I agree not to restrict the use of any data or results that
arise from this study provided such a use is only for scientific purpose(s). I have been given an
information sheet giving details of the study. I fully consent to participate in the above study.

इस अध्ययन का विवरण मुझे लिखित रूप में दिया गया है एवं मुझे अपनी भाषा में समझाया गया हैI में पुष्टि करता/करती हूँ कि मैंने उपरोक्त अध्ययन
को समझ लिया है एवं मुझे सवाल पूछने का अवसर मिला हैI में समझता/समझती हूँ कि इस अध्ययन में मेरी भागीदारी स्वैछिक है और में किसी भी
समय, बिना कोई कारन बताये अपनी सहभागिता वापस लेने के लिए स्वतंत्र हूँI मेरे इस अध्ययन से सहभागिता वापस लेने के बाद भी, चिकित्सा
देखभाल अस्पताल द्वारा सामान्य रूप से प्रदान कि जायेगीI इस अध्ययन से प्राप्त होने वाली जानकारी या परिणामों के प्रयोग को प्रतिबंधितन करने के
लिए में सहमत हूँ, लेकिन ऐसे उपयोग के वल वैज्ञानिक उद्देश्य (प्रयोजनों) के लिए होना चाहिए I मुझे एक सूचना पत्र दिया गया है, जिसमें अध्ययन का
विवरण दिया गया हैI उपरोक्त अध्ययन में भाग लेने के लिए में सहमति देता/देती हूँI

Signature of the participant/Thumb impression: _______________Date/दिनांक__________

प्रतिभागी के हस्ताक्षर/अंगूठे का निशान

Signature of the witness/गवाह के हस्ताक्षर__________________ Date/ दिनांक_________

Signature of the investigator/शोधकर्ता के हस्ताक्षर_____________Date/ दिनांक_________

Name of doctors - Place;-

Statement by Researcher/person taking consent: शोधकता / सहमति लेने वाले वक्तव्य:

I have accurately read out the information sheet to the potential participant, and to the best of
my ability made sure that the participant understands the purpose of study.

I confirm that the participant was given an opportunity to ask questions about the study, and all
the questions asked by the participant have been answered correctly and to the best of my
ability.

I confirm that the individual has not been coerced into giving consent, and the consent has
been given freely and voluntarily.
मैंने संभावित प्रतियोगी को सूचना पत्र को सटीक रूप से पढ़ कर बताया है, औरअपनी योग्यतम क्षमता से सुनिश्चित किया है की प्रतिभागी अध्ययन के
उद्देश्य को समझता है।
मैं पुष्टि करता/करती हूँ की प्रतिभागी को अध्ययन के बारे में प्रश्न पूछने का अवसर दिया गया था और प्रतिभागी द्वारा पूछे गए सभी प्रश्नो का सही
उत्तर मेरी सर्वोत्तम क्षमता अनुसार दिया गया है।
मैं पुष्टि करता/करती हूँ की प्रतिभागी को सहमति देने में मजबूर नहीं किया गया है और सहमति स्वतंत्र रूप एवं स्वेछा से प्रदान की गयी है।
Name of Researcher/person taking consent: _______________________________

शोधकर्ता/ सहमति लेने वाले व्यक्ति का नाम: : _______________________________

Signature of Researcher/person taking consent : _______________________________

शोधकर्ता / सहमति लेने वाले व्यक्ति का हस्ताक्षर : _______________________________

Date/दिनांक__________________

Place/स्थान_________________________

CERTIFICATE FROM INSTITUTION

This is to certify that required facilities for work in subject of thesis entitled Effect of C reactive
protein guided antibiotic treatment and duration of outcome admitted patients of community
acquired pneumonia admitted in metro hospital and heart centre gugrugram Haryana " do exist
in Metro hospital and Heart institute ,palam vihar (gurugram) and shall be provided to
candidate and will ensure that the data included in the Thesis will be genuine and candidate will
Himself do the work under guidance.

Under the guidance of

Guide and Head of Department
Dr.Manoj Kumar Dutta MBBS,
MD(Medicine ), DNB(Endocrinology)
Consultant and Head of Department
APPROVAL CERTIFICATE OF SCIENTIFIC COMMITTEE AND ITS COMPOSITION

APPROVAL CERTIFICATE OF ETHICAL COMMITTEE AND ITS COMPOSITION

(Signature of candidates)

(Signature of guide)
(signature of head of department)

SOURCE OF STUDY
This study is going to include patients of community acquired pneumonia who are admitted in
Metro hospital and heart institute gurugram haryana”.

STUDY DESIGN ; prospective study

SAMPLE SIZE: Sample size was determined by the formula based on the study population
n = Z2 pq/ e2

Where, Z=standard normal deviate

Power of study= 95%
17P= 20 - 30% (prevalence 23%)14
q= (1-p) =77%
e= permissible error in estimation of 7 incidence
n= sample size
The estimated sample size for the study came out to be 140

STUDY AREA: IPD patients of community acquired pneumonia who are admitted in Metro
hospital and heart institute gurugram haryana.

STUDY DURATION: 18 Months

DATA COLLECTION Detailed study proforma

STUDY POPULATION : : IPD patients of community acquired pneumonia who are admitted in
Metro hospital and heart institute gurugram haryana.

Statistical analysis:
1. Statistic software was use for collecting data and analysis namely statistical package for
social science SPSS version 18. Fishers exact test as appropriate , p<0.05 was considered to be
statistically significant.
2. Each entry was doubled check to avoid any possible error.
3. Graph and tables were drawn for summarizing and presenting the result.

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)

Sex Eligible for Study: All

Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
  Patients 18 years of age or older admitted to hospital with community acquired
pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough,
expectoration, dyspnea, fever and pathological lung-auscultation.
 Not admitted to hospital within the last 14 days
 The patients has been prescribed antibiotic treatment for pneumonia
 The patient can comprehend the written and verbal information and has provided
written consent.

Exclusion Criteria:
 Patient are unable to give written consent or patient does not understand the hindi or
english language.
 Active pulmonary tuberculosis
 Severe immunosuppression determined by the treating physician (i.e. treatment with
highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with
neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection
with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation).
 Pregnancy and breastfeeding
 Patients admitted to hospital and treated against their will.
 Terminal ill patients where active treatment is stopped within the first 48 hours of
admission.
 Patients who are, from the date of inclusion, prescribed antibiotic treatment for more
than 3 days on a different indication than pneumonia.
UNDERTAKING
l/'we agree to abide by the ethical guidelines for biomedical research on human subject (As per
the ICMR guidelines) while conducting the research project being submitted. for Ethical
Committee consideration:
Project is considered to be absolutely essential for the advancement of knowledge and for the
benefit of all.
Only subjects who volunteer for the project will be included. Their informed consent shall be
obtained.
pror to commencement of the research project, and subjects will be kept fully apraised of all the
consequences.
Privacy and confidentiality of the subjects shall be maintained and without the consent of
subjects no disclosure will be made.
Proper precautions shall be taken so as to minimize risk and prevent irreversible adverse effects.
Research will be conducted by the professionally competent persons.
Research will be conducted in a fair, honest, impartial and transparent manner.
Research will be accountable for maintaining proper records.
Research will be conducted keeping in view the public interest at large.
Research reports, materials and data will be preserved (as per institutional guidelines).
Results of research will be made known through scientific publications.
 Professional and moral responsibilities will be of the researchers, directly or indirectly
connected with the research.
Research will be conducted in a fair, honest, impartial and transparent manner.
Research will be accountable for maintaining proper records Research will be conducted keeping
in view the public interest at large.
Research reports, materials and data will be preserved (as per institutional guidelines).
Results of research will be made known through scientific publications Professional and moral
responsibilities will be of the researchers, directly or indirectly connected with the research.
Only those drugs which are approved by the Drug controller of India for a specific purpose will
be used in the research project.
Signature: Investigator: Dr SURESH PRAJAPATI
SignatureGuide: Dr. MK DUTTA

रोगी सूचना पत्र

अध्ययनकाशीर्षक

मुख्यअन्वेषकडॉसुरेशप्रजापति

डीएनबी

निवासीसामान्यचिकित्साविभाग-मेट्रोअस्पतालऔरहृदयसंस्थान

गाइड-डॉमनोजकु मारदत्ता

वरिष्ठसलाहकारएवंप्रधानाध्यक्षसामान्यचिकित्साविभागमेट्रोअस्पतालऔरहृदयसंस्थान

भागीदारीकीअवधिऔरप्रतिभागियोंकीसंख्या:: वर्ष 2022 से2025 के बीचइसअध्ययनमेंभागलेंगे।

उनकामूल्यांकनइंडोरऔरआईपीडीके आधारपरकियाजाएगा।

गोपनीयता
आपकीगोपनीयताकासम्मानकियाजाएगा।
आपकीविशिष्टसहमतिके बिनाआपके पहचानकाखुलासाकरनेवालोंकोकोईजानकारियांजारीप्रकाशितनहींकी
जाएगी।

अध्ययनके बारेमेंकिसीभीरिपोर्टमेंआपकीपहचानकाउपयोगयाखुलासानहींकियाजाएगा।
अध्ययनरिकॉर्डमेंस्थानछोड़नेपरआपकोके वलएकअध्ययनकोडद्वारापहचानाजाएगा।
अनुसंधानरिकॉर्डऔरमेडिकलरिकॉर्डजोआपकीपहचानकरतेहैंकानिरीक्षणअनुसंधानकीनिगरानीके उद्देश्यसे
अन्वेषकयाउनके नामितऔरअनुसंधाननैतिकताबोर्डकीउपस्थितिमेंकियाजासकताहै।
हालांकिकोईरिकॉर्डनहींहैकिआपकीपहचानआपकोअस्पतालछोड़नेकीअनुमतिदीजाएगी।

भागलेनेऔरअध्ययनसेवापसलेनेकीस्वतंत्रताहोगी।
आपकोअध्ययनमेंभागलेनेके लिएएकसहमतीफॉर्मपरहस्ताक्षरकरनेके लिएकहाजाएगा।
इलाजकरनेवालेडॉक्टरभीफॉर्मपरहस्ताक्षरकरेगा।

आपपत्रपरहस्ताक्षरकरेंगेकि

"मुझेसूचनापत्रकीएकप्रतिदीगईहैजिससेडॉक्टररखेंगे।
आपकोअपनेरिकॉर्डके लिएएकऔरप्रतिप्रदानकीजाएगी।
आपकोरोग,निदानप्रबंधनऔरअध्ययनके बारेमेंकोईप्रश्नपूछनेके लिएस्वतंत्रमहसूसकरनाचाहिए।
आपकाडॉ.आपकोजवाबदेनेमेंप्रसन्नहोगायदिआपकिसीभीसमयअध्ययनसेहटनेकानिर्णयलेतेहैंतोआपऐसा
करनेके लिएस्वतंत्रहोंगे।
ABBREVIATION

- CAP: community acquired pneumonia

-PCT: PROCALCITONIN

-CRP: C-reactive protein

-ESR :Erythrocyte sedimentation rate

-AFB –Acid Fast Bacilli