RAJIV GANDHI UNIVERSITY OF HEALTH SCINCES, …



|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE |

|ANNEXURE-II |

|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

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|1 |NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) |DR. SANTHOSH.B.GADADAVAR |

| | |POST GRADUATE STUDENT, |

| | |DEPT OF MICROBIOLOGY, |

| | |KIMS, HUBLI - 22 |

| | | |

|2 |NAME OF THE INSTITUTION |KARNATAKA INSTITUTE OF |

| | |MEDICAL SCIENCES, |

| | |HUBLI-580 022. |

| | | |

|3 |COURSE OF STUDY AND SUBJECT |M. D. MICROBIOLOGY |

| | | |

|4 |DATE OF ADMISSION TO COURSE |30TH JUNE 2010 |

|5 |TITLE OF THE TOPIC |“COMMUNITY AND HOSPITAL ACQUIRED GRAM NEGATIVE UROPATHOGENS: |

| | |MICROBIOLOGICAL PROFILE, ESBL AND AMP-C BETA LACTAMASE |

| | |PRODUCTION” |

|6 |BRIEF RESUME OF THE INTENDED WORK: |

| | |

| |6.1 NEED FOR THE STUDY: |

| |DESPITE THE WIDESPREAD AVAILABILITY OF ANTIBIOTICS, URINARY TRACT INFECTION REMAINS THE MOST COMMON BACTERIAL INFECTION IN |

| |THE HUMAN POPULATION IN BOTH HOSPITAL AND COMMUNITY SETTING.1 IN GENERAL, ESCHERICHIA COLI, KLEBSIELLA, PROTEUS, PSEUDOMONAS,|

| |ENTEROBACTER AND ACINETOBACTER SPECIES ETC HAVE BEEN REPORTED TO CAUSE URINARY TRACT INFECTION.2,3,4 |

| |The etiology of urinary tract infections and the antibiotic resistance of uropathogens has been changing over the past years |

| |both in community and nosocomial infections.5,6 Production of Extended Spectrum Beta Lactamases (ESBL) and Amp-C beta |

| |lactamases are the most common mechanisms of antimicrobial resistance in Gram negative bacilli.3 |

| |ESBL producing strains have spread to the community whereas Amp-C harbouring strains are still limited to the hospital.7 |

| |There is a paucity of data regarding ESBL and Amp-C beta lactamase production among uropathogens. Besides it is important to |

| |understand the extent of spread of these isolates in the community so as to formulate corrective measures. |

| |Hence the following study is conducted to find and compare antimicrobial resistance pattern, incidence of ESBL and Amp-C beta|

| |lactamase production among Gram negative uropathogens of community and hospital origin at Karnataka Institute of Medical |

| |Sciences Hospital , Hubli. |

| | |

| | |

| |6.2. REVIEW OF LITERATURE : |

| |A STUDY DONE BY ALLAN RONALD SHOWED THAT ESCHERICHIA COLI REMAINS THE PREDOMINANT UROPATHOGEN (80%) ISOLATED IN ACUTE |

| |COMMUNITY-ACQUIRED UNCOMPLICATED INFECTIONS, FOLLOWED BY STAPHYLOCOCCUS SAPROPHYTICUS, KLEBSIELLA, ENTEROBACTER AND PROTEUS |

| |SPECIES.8 |

| | |

| | |

| |A STUDY DONE BY NEELAM TANEJA, POOJA RAO, JITENDER ARORA &ASHOK DOGRA FOUND THAT PRODUCTION OF EXTENDED SPECTRUM BETA|

| |LACTAMASE AND AMP-C BETA LACTAMASES ARE THE MOST COMMON MECHANISMS OF ANTIMICROBIAL RESISTANCE IN GRAM NEGATIVE BACILLI. IN |

| |THEIR STUDY 36.5% OF GRAM NEGATIVE URINARY ISOLATES WERE ESBL PRODUCERS. HIGHEST ESBL POSITIVITY WAS FOUND IN KLEBSIELLA |

| |SPECIES(51.2%) FOLLOWED BY ESCHERICHIA COLI(40.2%),ENTEROBACTER AEROGENES(33.4%) AND PSEUDOMONAS AERUGINOSA(27.9%). BOTH ESBL|

| |PRODUCERS AND NONPRODUCERS SHOWED HIGH DEGREE RESISTANCE TO BETA LACTAM ANTIBIOTICS. THIS STUDY ALSO REPORTED 53 ISOLATES TO |

| |BE POSITIVE FOR AMP-C BETA LACTAMASE.3 |

| | |

| |A STUDY DONE BY SUPRIYA S TANKHIWALE, SURESH V JALGAONKAR AT GOVT MEDICAL COLLEGE NAGPUR REPORTED 48.3% ESBL PRODUCERS AMONG |

| |GRAM NEGATIVE URINARY ISOLATES OF SYMPTOMATIC URINARY TRACT INFECTION CASES ATTENDING OR ADMITTED TO INDIRA GANDHI MEDICAL |

| |COLLEGE AND HOSPITAL.1 |

| | |

| |A STUDY BY NACHIMUTHU RAMESH, CHETTIPALAYAN S S AT BHARATIDARSHAN UNIVERSITY,TIRUCHIRAPALLI REPORTED ESCHERICHIA COLI, |

| |KLEBSIELLA, PSEUDOMONAS, ACINETOBACTER, PROTEUS, ENTEROBACTER, STAPHYLOCOCCUS SP, ENTEROCOCCUS, CITROBACTER, SERRATIA AS THE |

| |CAUSATIVE AGENTS OF URINARY TRACT INFECTIONS AND OBSERVED ESBL PRODUCTION IN 71.5% OF GRAM NEGATIVE BACILLI IN BOTH |

| |OUTPATIENTS AND INPATIENTS.9 |

| | |

| |A STUDY DONE BY S UZUNOVIC-KAMBEROVIC, D SARIC, S SESTIC AT CANTONAL HOSPITAL, BOSNIA& HERZEGOVINA FOUND 2.6% ESBL PREVALENCE|

| |IN COMMUNITY ACQUIRED URINARY TRACT INFECTIONS. ESCHERICHIA COLI WAS RESPONSIBLE FOR 62.3% OF THE INFECTIONS.10 |

| |A STUDY DONE BY RUBENS CLAYTON DA SILVA DIAS, ARMANDO ALVES BORGES-NETO ET AL AT A LARGE URBAN UNIVERSITY HOSPITAL IN BRAZIL |

| |OBSERVED PREVALENCE OF AMP-C BETA LACTAMASES IN 12% OF ESCHERICHIA COLI ISOLATES.11 |

| | |

| |IN A STUDY CONDUCTED BY VIKAS MANCHANDA AND NARENDRA P S AT GURU TEGH BAHADUR HOSPITAL, DELHI FOUND THAT ESBL PRODUCING |

| |STRAINS OF ESCHERICHIA COLI WERE ISOLATED FROM INPATIENTS AS WELL AS FROM OUTPATIENTS. IN CONTRAST ALL THE AMP-C HARBOURING |

| |ORGANISMS WERE FOUND ONLY IN CLINICAL SAMPLES FROM ADMITTED PATIENTS. THE OVERALL AMP-C PRODUCTION WAS NOTED IN 20.7% OF THE |

| |CASES. THE GRAM NEGATIVE BACILLI INCLUDED IN THE STUDY WERE NON-ENTERIC CLINICAL ISOLATES.7 |

| | |

| |6.3 OBJECTIVES OF STUDY : |

| |TO ISOLATE AND IDENTIFY THE GRAM NEGATIVE UROPATHOGENS AMONG COMMUNITY AND HOSPITAL ACQUIRED URINARY TRACT INFECTIONS. |

| |TO FIND AND COMPARE THE ANTIMICROBIAL SUSCEPTIBILITY PATTERNS OF THE ISOLATED GRAM NEGATIVE UROPATHOGENS AMONG COMMUNITY AND |

| |HOSPITAL ACQUIRED URINARY TRACT INFECTIONS. |

| |TO FIND AND COMPARE THE INCIDENCE OF ESBL AND AMP-C BETA LACTAMASE PRODUCING UROPATHOGENS AMONG COMMUNITY AND HOSPITAL |

| |ACQUIRED URINARY TRACT INFECTIONS |

| |MATERIALS AND METHOD |

| | |

| |SOURCE OF DATA : |

| |URINE SAMPLES OF ADULTS COLLECTED FROM INPATIENT AND OUTPATIENT DEPARTMENT OF |

| |Karnataka Institute of Medical Sciences Hospital, Hubli. |

| | |

| | |

| |7.2 Methods of collection of data: |

| |Period of study: December 2010-November 2011 |

| | |

| |DESIGN OF STUDY: CROSS SECTIONAL STUDY. STATISTICAL ANALYSIS WILL BE DONE USING CHI-SQUARE TEST. |

| | |

| |INCLUSION CRITERIA: |

| |ONLY ADULT PATIENTS WITH SUSPECTED URINARY TRACT INFECTION. |

| |FOR HOSPITAL ACQUIRED URINARY TRACT INFECTION, URINE SAMPLE |

| |FROM INPATIENT ADULTS ADMITTED FOR NOT LESS THAN 3 DAYS(72 |

| |HOURS) WITH CLINICAL SUSPICION OF URINARY TRACT INFECTION.12 |

| |FOR COMMUNITY ACQUIRED URINARY TRACT INFECTION, URINE SAMPLES |

| |FROM OUTPATIENT ADULTS WHO WERE NOT HOSPITALIZED OR RESIDING IN A LONG TERM CARE FACILITY FOR MORE THAN 14 DAYS BEFORE THE |

| |ONSET OF SYMPTOMS.12 |

| |ONLY GRAM NEGATIVE UROPATHOGENS WILL BE INCLUDED. |

|7 |EXCLUSION CRITERIA: |

| |PEDIATRIC PATIENTS. |

| |ISOLATES OTHER THAN GRAM NEGATIVE BACILLI. |

| |REPEAT ISOLATES FROM SAME PATIENT. |

| |SIZE OF STUDY SAMPLE: |

| |GRAM NEGATIVE UROPATHOGENS ISOLATED IN DEPARTMENT OF MICROBIOLOGY, KARNATAKA INSTITUTE OF MEDICAL SCIENCES HOSPITAL, HUBLI IS|

| | |

| |APPROXIMATELY 28-30/MONTH I.E; 336-360/YEAR. SO ALL THE CASES AS PER INCLUSION CRITERIA WILL BE INCLUDED WITH A NUMBER |

| |RESTRICTED TO100 SAMPLES EACH OF COMMUNITY ACQUIRED AND HOSPITAL ACQUIRED UROPATHOGENS. |

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| | |

| |D)METHOD : |

| | |

| |SAMPLE COLLECTION: |

| |COMMUNITY ACQUIRED UTI : 2ML MIDSTREAM URINE SAMPLE WILL BE COLLECTED UNDER ASEPTIC PRECAUTIONS FROM ADULT PATIENTS |

| |PRESENTING AT OUTPATIENT DEPARTMENT. |

| |HOSPITAL ACQUIRED UTI :2ML MIDSTREAM URINE SAMPLE OR URINE SAMPLE FROM CATHETER TUBE WILL BE COLLECTED UNDER ASEPTIC |

| |PRECAUTIONS FROM INPATIENTS WITH CLINICAL SUSPICION OF UTI. |

| | |

| |PROCESSING OF SAMPLE: |

| |URINE SAMPLES WILL BE PROCESSED AND INTERPRETED AS PER THE STANDARD PROTOCOL.13 SAMPLES WILL BE CULTURED ON BLOOD AGAR AND |

| |MCCONKEY AGAR AND INCUBATED OVERNIGHT AT 370C. ALL SPECIMENS REVEALING SIGNIFICANT BACTERIURIA WILL BE FURTHER IDENTIFIED BY|

| |RELEVANT BIOCHEMICAL TESTS. |

| | |

| |ANTIMICROBIAL SUSCEPTIBILITY TESTING WILL BE DONE AS PER CLSI GUIDELINES.14 PRESENCE OF ESBL WILL BE DETECTED BY PHENOTYPIC |

| |CONFIRMATORY TEST BY DISK DIFFUSION METHOD USING DISKS CONTAINING 30µG OF CEFTAZIDIME WITH AND WITHOUT 10µG OF CLAVULANIC |

| |ACID ON MUELLER-HINTON AGAR. ESBL PRODUCTION IS INFERRED IF THE INHIBITION ZONE INCREASES BY 5MM TOWARDS CEFTAZIDIME PLUS |

| |CLAVULANIC ACID IN COMPARISON TO 3RD GENERATION CEPHALOSPORIN DISK ALONE. 14 |

| |SCREENING FOR AMP-C BETA LACTAMASE WILL BE DONE USING30µG CEFOXITIN DISK AND ISOLATES WITH REDUCED SUSCEPTIBILITY TO |

| |CEFOXITIN WILL BE TESTED FOR AMP-C BY MODIFIED THREE DIMENSIONAL TEST. A CLEAR DISTORTION OF CEFOXITIN INHIBITION ZONE(>5MM)|

| |WILL BE INTERPRETED AS A POSITIVE RESULT FOR AMP-C PRODUCER.11 |

| |STATISTICAL ANALYSIS WILL BE DONE . |

| | |

| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS (OR) |

| |ANIMALS SPECIFY. |

| |NO, THE URINE SAMPLES RECEIVED IN THE MICROBIOLOGY LABORATORY WILL BE UTILIZED FOR STUDY. NO ADDITIONAL INVESTIGATION OR |

| |INTERVENTION WILL BE CONDUCTED ON THE PATIENT. |

| | |

| | |

| |7.4 HAS ETHICAL CLEARANCES BEEN OBTAINED FROM ETHICAL COMMITTEE OF YOUR |

| |INSTITUTION IN CASE OF 7.3 ? |

| |‘YES’, ETHICAL CLEARANCE HAS BEEN OBTAINED FROM ETHICAL COMMITTEE OF KIMS , HUBLI. |

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|8 |LIST OF REFERENCES : |

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| |TANKHIWALE S S, JALGAONKAR S V, AHAMAD S & HASSANI U. EVALUATION OF EXTENDED SPECTRUM BETA LACTAMASE IN URINARY ISOLATES :|

| |INDIAN J MED RES DECEMBER 2004;120:553-556 |

| | |

| |AKRAM M, SHAHID M AND KHAN A U. ETIOLOGY AND ANTIBIOTIC RESISTANCE PATTERNS OF COMMUNITY-ACQUIRED URINARY TRACT INFECTIONS |

| |IN J N M C HOSPITAL ALIGARH, INDIA: ANN CLIN MICROBIOL ANTIMICROB 2007,VOL6(1). |

| | |

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| |TANEJA N, RAO P, ARORA J & DOGRA A. OCCURRENCE OF ESBL & AMP-C BETA LACTAMASES & SUSCEPTIBILITY TO NEWER ANTIMICROBIAL |

| |AGENTS IN COMPLICATED UTI: INDIAN J MED RES, JANUARY 2008;127:85-88 |

| | |

| |TABIBIAN J H, GORNBEIN J, HEIDARI A ET AL. UROPATHOGENS AND HOST CHARACTERISTICS. J CLIN MICROBIOL DECEMBER 2008;46(12): |

| |3980-3986. |

| | |

| |NEU H C. URINARY TRACT INFECTIONS. AM J MED 1992;92(4A):63-70 |

| | |

| |SCHAEFFER A J. URINARY TRACT INFECTIONS IN ELDERLY. EUR UROL 1991;19:2-6 |

| | |

| |MANCHANDA V AND SINGH N P. OCCURRENCE AND DETECTION OF AMP-C BETA |

| |LACTAMASES AMONG GRAM-NEGATIVE CLINICAL ISOLATES USING A MODIFIED THREE- |

| |DIMENSIONAL TEST AT GURU TEGH BAHADUR HOSPITAL, DELHI, INDIA. J ANTIMICROB |

| |CHEMOTHER 2003 ;51(2):415-418 |

| | |

| |RONALD A. THE ETIOLOGY OF URINARY TRACT INFECTIONS: TRADITIONAL AND EMERGING PATHOGENS. DIS MON2003; 49(2):71-82. |

| | |

| |RAMESH N, CHETTIPALAYAM S S ET AL. URINARY TRACK INFECTION |

| |AND ANTIMICROBIAL SUSCEPTIBILITY PATTERN OF EXTENDED SPECTRUM OF BETA |

| |LACTAMASE PRODUCING CLINICAL ISOLATES. ADVAN BIOL RES 2008 ;2(5-6):78-82 |

| | |

| | |

| | |

| |UZUNOVIC-KAMBEROVIC S, SARIC D, SESTIC S. COMMUNITY-ACQUIRED URINARY TRACT INFECTIONS BY EXTENDED SPECTRUM OF BETA LACTAMASE |

| |-PRODUCING ENTEROBACTERIACEAE IN ZENICA-DOBOJ CANTON, BOSNIA AND HERZEGOVINA: MEDICINSKI GLASNIK, AUGUST 2006 ;3(2); 46-52 |

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| |DA SILVA DIAS R C, ARMANDO ALVES BORGES-NETO ET AL. PREVALENCE OF AMP-C AND OTHER BETA-LACTAMASES IN ENTEROBACTERIA AT A |

| |LARGE URBAN UNIVERSITY HOSPITAL IN BRAZIL. DIAGN MICROBIOL INFECT DIS JAN 2008;60(1):79-87 |

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| |JACOBS R A, GUGLIELMO B J, CHIN-HONG P V. COMMON PROBLEMS IN INFECTIOUS DISEASES AND ANTIMICROBIAL CHEMOTHERAPY. CURRENT |

| |MEDICAL DIAGNOSIS AND TREATMENT 2008 , 47TH EDN: 1103-1149 |

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| |KONEMAN EW, ALLEN SD, JANDA WM, SCHRECKENBERGER PC, WINN WC JR, WOODS G, PROCOP G . COLOR ATLAS AND TEXTBOOK OF DIAGNOSTIC |

| |MICROBIOLOGY, 6TH EDITION PHILADELPHIA. LIPPINCOTT WILLIAMS AND WILKINS PUBLISHERS;2006. CHAPTER 2:82-87 |

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| |CLINICAL AND LABORATORY STANDARDS INSTITUTE. PERFORMANCE STANDARDS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING; 17TH |

| |INFORMATIONAL SUPPLEMENT 2007. |

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|9 |SIGNATURE OF THE CANDIDATE: | |

|10 |REMARKS OF THE GUIDE: | |

|11 |NAME AND DESIGNATION OF |DR.ASHA PATIL |

| |11.1 GUIDE |M.D. MICROBIOLOGY. |

| | |ASSOCIATE PROFESSOR , DEPARTMENT OF MICROBIOLOGY, |

| | |KIMS, HUBLI |

| |11.2 SIGNATURE: | |

| | | |

| |11.3 CO-GUIDE: | |

| |11.4 SIGNATURE: | |

| |11.5 HEAD OF THE DEPARTMENT: |DR.SHOBHA D. NADAGIR |

| | |M.D. MICROBIOLOGY. |

| | |PROFESSOR & HEAD, DEPARTMENT OF MICROBIOLOGY, |

| | |KIMS, HUBLI |

| |11.6 SIGNATURE: | |

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|12 |12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL: | |

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| |12.2 SIGNATURE: | |

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