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Study protocol: characterising the clinical, epidemiological and aetiological aspects of leptospirosis in Sri Lanka: a hospital based clinico-epidemiological study
  1. Suneth Agampodi1,
  2. Janith Warnasekara1,
  3. Dinesha Jayasundara2,
  4. Indika Senawirathna3,
  5. Chandika Gamage4,
  6. Senanayake Kularatne5,
  7. Sisira Siribaddana6,
  8. Michael Maththias7,
  9. Joseph Vinetz7
  1. 1Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
  2. 2Department of Microbiology, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
  3. 3Department of Biochemistry, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
  4. 4Department of Microbiology, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
  5. 5Department of Medicine, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
  6. 6Department of Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
  7. 7Yale University School of Medicine, New Haven, Connecticut, USA
  1. Correspondence to Dr Suneth Agampodi; sunethagampodi{at}yahoo.com

Abstract

Introduction Sri Lanka has one of the highest incidences of leptospirosis worldwide. We hypothesised that different geographical locations and patient context will have a distinct molecular epidemiology of leptospirosis, based on microgeographical characteristics related to regiona-specific Leptospira predominance. Our objective is to characterise the clinical, epidemiological and molecular aspects of leptospirosis in Sri Lanka to understand disease progression, risk factors and obtain isolates of Leptospira.

Methods and analysis We designed a multicentre prospective study in Sri Lanka to recruit undifferentiated febrile patients and conduct follow-ups during hospital stays. Patients will be recruited from outpatient departments and medical wards. This study will be conducted at two main sites (Anuradhapura and Peradeniya) and several additional sites (Awissawella, Ratnapura and Polonnaruwa). Blood and urine will be collected from patients on the day of admission to the ward or presentation to the outpatient department. Bedside inoculation of 2–4 drops of venous blood will be performed with Ellinghausen-McCullough-Johnson-Harris (EMJH) semisolid media supplemented with antibiotics. Regionally optimised microscopic agglutination test, culture and qPCR-evidence will be performed to confirm the presence of Leptospira in blood which in turn will confirm the presence of disease. Whole genome sequencing will be carried out for all isolates recovered from patients. Multilocus sequence typing (MLST) will be used for the genotyping of new isolates. Sri Lankan isolates will be identified using three published MLST schemes for Leptospira.

Ethics and dissemination Ethical clearance for the study was obtained from Ethics Review Committees (ERC), Medicine and Allied Sciences (FMAS), Rajarata University of Sri Lanka (RUSL) and University of Peradeniya. All genomic data generated through this project will be available at GenBank. Anonymised data will be deposited at the ERC, FMAS, RUSL.

  • leptospirosis
  • Sri Lanka
  • leptospira
  • isolates
  • whole genome sequencing
  • clinical disease

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JV and SA drafted the initial protocol. JW, DJ and IS are responsible for the detailed design, field/ laboratory work analysis and interpretation of objectives 1-3, 4 and 5, respectively. CG, SK and SS helped in design, field, hospital and laboratory work. MM participated in scientific design and guided all laboratory components. All authors have read and approved the manuscript.

  • Funding This project is the Sri Lankan component of a multicountry study funded by the NIAID of the National Institutes of Health under award number U19AI115658. Funders had no role in the design, execution, analyses, data interpretation or decision to submit results.

  • Map disclaimer The depiction of boundaries on the map(s) in this article do not imply the expression of any opinion whatsoever on the part of BMJ (or any member of its group) concerning the legal status of any country, territory, jurisdiction or area or of its authorities. The map(s) are provided without any warranty of any kind, either express or implied.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical clearance for the study was obtained from the Ethic Review Committees of Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka (ERC/2015/18).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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