Prospective, observational study to assess the performance of CAA measurement as a diagnostic tool for the detection of
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(2020) 20:718
STUDY PROTOCOL
Open Access
Prospective, observational study to assess the performance of CAA measurement as a diagnostic tool for the detection of Schistosoma haematobium infections in pregnant women and their child in Lambaréné, Gabon: study protocol of the freeBILy clinical trial in Gabon Yabo Josiane Honkpehedji1,2,3, Ayôla Akim Adegnika1,2,3,4, Jean Claude Dejon-Agobe1,2,5, Jeannot Fréjus Zinsou1,2, Romuald Beh Mba1, Jacob Gerstenberg1,2, Raphaël Rakotozandrindrainy6, Rivo Andry Rakotoarivelo7, Tahinamandranto Rasamoelina8, Elisa Sicuri9, Norbert G. Schwarz10, Paul L. A. M. Corstjens11, Pytsje T. Hoekstra3, Govert J. van Dam3, Andrea Kreidenweiss2,11* and on behalf of the freeBILy Consortium
Abstract Background: Schistosoma antigen detection in urine is a valuable diagnostic approach for schistosomiasis control programmes because of the higher sensitivity compared to parasitological methods and preferred sampling of urine over stool. Highly accurate diagnostics are important in low Schistosoma transmission areas. Pregnant women and young children could particularly benefit from antigen testing as praziquantel (PZQ) can be given to only confirmed Schistosoma cases. This prevents the unborn baby from unnecessary exposure to PZQ. We present here the protocol of a diagnostic study that forms part of the freeBILy project. The aim is to evaluate the accuracy of circulating anodic antigen (CAA) detection for diagnosis of Schistosoma haematobium infections in pregnant women and to validate CAA as an endpoint measure for anti-Schistosoma drug efficacy. The study will also investigate Schistosoma infections in infants. (Continued on next page)
* Correspondence: [email protected] 2 Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany 11 Department of Cell and Chemical Biology, Leiden University Medical Center, Leiden, the Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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