12-13 July 2018
This meeting brought together epidemiologists, lab specialists and data managers working on Vietnam and Myanmar components of ECOMORE2 project and external experts as well. Before meeting all participants received one week in advance protocols and CRF of both components
From NIHE, Dr. Le Thi Phuong Mai, Head of Department of Public Health, Mrs. Nguyen Thi My Hanh, responsible of data entry and mapping, Mrs. Luu Phuong Dung, Data Manager, Mr. Tran Van Dinh, Supervisor of field study, Hoang Thi Thu Ha, Head of the Microbiology Department, participated actively in this workshop. From Myanmar, Mrs. May July, Data Manager at NHL and Dr. Etienne Chevanne, epidemiologist contributed keenly to the discussions. This transversal workshop welcomed the contribution of Dr. Cyrille Goarant, Head of the URE (Unit of Research and Expertise) on Leptospirosis at Institut Pasteur in New Caledonia and Dr. Huynh Bich Tram, from the Biostatistics, Biomathematics, Pharmaco-epidemiology and Infectious Diseases Research Unit at Institut Pasteur in Paris.
This meeting focused on review and harmonization of data collection to ensure matching with the objectives of the studies and to enable drawing a parallel between both components; the participants have concentrated on:
- Review and harmonization of the case definition; the challenge was to issue a simple scoring for leptospirosis suspicion to facilitate screening of outpatient at hospital, to prevent missing any case and finally to consider lab testing work and budget. This initial case definition will be likely refined after the 2-month pilot phase and after the Working Groups with Medical Doctors animated by Dr. Yupin Suputtamongkol of Mahidol University, world specialist of leptospirosis.
- Review of the Case Reporting Forms for suspected patients at hospital and for case control patients. This mutual review and external expertise was critical to ensure that data to be collected will match with the purpose of the study and the content of the protocol.
Some major indicators (like anuria/oliguria) have been added while some duplicates were deleted or others were simplified. - Review of dynamic of the disease in correlation with bacteremia and antibodies detection; a comprehensive Power Point presentation was made by Cyrille Goarant (read more) to provide clear fundamentals before scrutinizing algorithms for lab testing.
- Review of algorithms of laboratory testing in consideration of laboratory capacities and logistics constrains; in Myanmar, samples will be collected daily from 9 main hospitals in Yangon city and its surrounding, while in Vietnam patients will be sampled in South, Central and North Vietnam in 3 provincial and 6 district hospitals.
On the other hand, extraction of DNA will be necessary to perform genotyping and so to compare serotypes circulating in both countries; positive PCR specimens will be used in Myanmar because all suspected patients will be tested by qPCR. In Vietnam Dr Goarant suggested to test by PCR sera negative for the 1st sampling but showing sero-conversion for the 2nd sampling; the dynamic of bacteremia and antibodies previously presented, demonstrate that this negative specimens will likely contain Leptospires.
Lab technicians from NIHE and NHL will participate in a complete lab training on sequencing of Leptospires at IPNC to continue the initial training conducted at NHL (see video) - The participants debated about a rigorous lab quality control. At NIHE, the control of ELISA testing will be done by performing MAT routinely; the concern is that nowadays, it is quite impossible to get reference anti-sera. So IPNC will provide a panel of 23 strains to refresh the collection at NIHE. At NHL, ELISA result will be checked by MAT at IPNC.
- Both parties discussed on continuing transversal collaboration (mutual review of data management), on external expertise shared by both studies and possible joint publications.
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