Download
s12879-020-05445-1.pdf 884,23KB
WeightNameValue
1000 Titel
  • 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
1000 Autor/in
  1. Honkpehedji, Yabo Josiane |
  2. Adegnika, Ayôla Akim |
  3. Dejon-Agobe, Jean Claude |
  4. Zinsou, Jeannot Fréjus |
  5. Mba, Romuald Beh |
  6. Gerstenberg, Jacob |
  7. Rakotozandrindrainy, Raphaël |
  8. Rakotoarivelo, Rivo Andry |
  9. Rasamoelina, Tahinamandranto |
  10. Sicuri, Elisa |
  11. Schwarz, Norbert G. |
  12. Corstjens, Paul L. A. M. |
  13. Hoekstra, Pytsje T. |
  14. van Dam, Govert J. |
  15. Kreidenweiss, Andrea |
  16. van Dam, G. J. |
  17. Corstjens, P. L. A. M. |
  18. Amoah, A. S. |
  19. de Dood, C. J. |
  20. Keshinro, M. I. |
  21. Hoekstra, P. T. |
  22. Kreidenweiss, A. |
  23. Schwarz, N. G. |
  24. Fusco, D. |
  25. Klein, P. |
  26. Jaeger, A. |
  27. Lorenz, E. |
  28. Adegnika, A. A. |
  29. Honkpehedji, Y. J. |
  30. Dejon-Agobe, J. C. |
  31. Mba, R. Beh |
  32. Ngwese, M. Mbong |
  33. Maloum, M. Nzamba |
  34. Moure, A. Nguema |
  35. Meulah, B. T. |
  36. Rakotozandrindrainy, R. |
  37. Rakotozandrindrainy, N. |
  38. Solonirina, M. J. |
  39. Randriamaniara, J. |
  40. Rakotoarivelo, R. A. |
  41. Ralaizandry, A. |
  42. Radomanana, M. |
  43. Andrianarivelo, M. Rakoto |
  44. Rasamoelina, T. |
  45. Razafindrakoto, R. |
  46. Siciru, E. |
  47. Aerts, C. |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-09-29
1000 Erschienen in
1000 Quellenangabe
  • 20(1):718
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s12879-020-05445-1 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7523491/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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.!##!Methods!#!A set of three interlinked prospective, observational studies is conducted in Gabon. The upconverting phosphor lateral flow (UCP-LF) CAA test is the index diagnostic test that will be evaluated. The core trial, sub-study A, comprehensively evaluates the accuracy of the UCP-LF CAA urine test against a set of other Schistosoma diagnostics in a cross-sectional trial design. Women positive for S. haematobium will proceed with sub-study B and will be randomised to receive PZQ treatment immediately or after delivery followed by weekly sample collection. This approach includes comparative monitoring of CAA levels following PZQ intake and will also contribute further data for safety of PZQ administration during pregnancy. Sub-study C is a longitudinal study to determine the incidence of S. haematobium infection as well as the age for first infection in life-time.!##!Discussion!#!The freeBILy trial in Gabon will generate a comprehensive set of data on the accuracy of the UCP-LF CAA test for the detection of S. haematobium infection in pregnant women and newborn babies and for the use of CAA as a marker to determine PZQ efficacy. Furthermore, incidence of Schistosoma infection in infants will be reported. Using the ultrasensitive diagnostics, this information will be highly relevant for Schistosoma prevalence monitoring by national control programs as well as for the development of medicaments and vaccines.!##!Trial registration!#!The registration number of this study is NCT03779347 ( clinicaltrials.gov , date of registration: 19 December 2018).
1000 Sacherschließung
lokal Infant, Newborn [MeSH]
lokal Schistosomiasis haematobia/epidemiology [MeSH]
lokal Anthelmintics/therapeutic use [MeSH]
lokal Gabon/epidemiology [MeSH]
lokal Praziquantel/therapeutic use [MeSH]
lokal UCP-LF CAA
lokal Data Accuracy [MeSH]
lokal Schistosomiasis haematobia/parasitology [MeSH]
lokal Infant [MeSH]
lokal Schistosomiasis
lokal Praziquantel
lokal Prevalence [MeSH]
lokal Immunologic Tests/methods [MeSH]
lokal Schistosomiasis haematobia/drug therapy [MeSH]
lokal
lokal Diagnostic test
lokal Female [MeSH]
lokal Follow-Up Studies [MeSH]
lokal Parasitological diseases
lokal Pregnancy
lokal Study Protocol
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Longitudinal Studies [MeSH]
lokal Cross-Sectional Studies [MeSH]
lokal Animals [MeSH]
lokal Infant
lokal Schistosomiasis haematobia/diagnosis [MeSH]
lokal Clinical trial
lokal Antigens, Helminth/analysis [MeSH]
lokal Schistosoma haematobium/genetics [MeSH]
lokal Schistosoma haematobium/immunology [MeSH]
lokal Pregnancy [MeSH]
lokal Gabon
lokal Child, Preschool [MeSH]
lokal Real-Time Polymerase Chain Reaction [MeSH]
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/SG9ua3BlaGVkamksIFlhYm8gSm9zaWFuZQ==|https://frl.publisso.de/adhoc/uri/QWRlZ25pa2EsIEF5w7RsYSBBa2lt|https://frl.publisso.de/adhoc/uri/RGVqb24tQWdvYmUsIEplYW4gQ2xhdWRl|https://frl.publisso.de/adhoc/uri/Wmluc291LCBKZWFubm90IEZyw6lqdXM=|https://frl.publisso.de/adhoc/uri/TWJhLCBSb211YWxkIEJlaA==|https://frl.publisso.de/adhoc/uri/R2Vyc3RlbmJlcmcsIEphY29i|https://frl.publisso.de/adhoc/uri/UmFrb3RvemFuZHJpbmRyYWlueSwgUmFwaGHDq2w=|https://frl.publisso.de/adhoc/uri/UmFrb3RvYXJpdmVsbywgUml2byBBbmRyeQ==|https://frl.publisso.de/adhoc/uri/UmFzYW1vZWxpbmEsIFRhaGluYW1hbmRyYW50bw==|https://frl.publisso.de/adhoc/uri/U2ljdXJpLCBFbGlzYQ==|https://frl.publisso.de/adhoc/uri/U2Nod2FyeiwgTm9yYmVydCBHLg==|https://frl.publisso.de/adhoc/uri/Q29yc3RqZW5zLCBQYXVsIEwuIEEuIE0u|https://frl.publisso.de/adhoc/uri/SG9la3N0cmEsIFB5dHNqZSBULg==|https://frl.publisso.de/adhoc/uri/dmFuIERhbSwgR292ZXJ0IEou|https://orcid.org/0000-0002-5025-7221|https://frl.publisso.de/adhoc/uri/dmFuwqBEYW0sIEcuIEou|https://frl.publisso.de/adhoc/uri/Q29yc3RqZW5zLCBQLiBMLiBBLiBNLg==|https://frl.publisso.de/adhoc/uri/QW1vYWgsIEEuIFMu|https://frl.publisso.de/adhoc/uri/ZGUgRG9vZCwgQy4gSi4=|https://frl.publisso.de/adhoc/uri/S2VzaGlucm8sIE0uIEku|https://frl.publisso.de/adhoc/uri/SG9la3N0cmEsIFAuIFQu|https://frl.publisso.de/adhoc/uri/S3JlaWRlbndlaXNzLCBBLg==|https://frl.publisso.de/adhoc/uri/U2Nod2FyeiwgTi4gRy4=|https://frl.publisso.de/adhoc/uri/RnVzY28sIEQu|https://frl.publisso.de/adhoc/uri/S2xlaW4sIFAu|https://frl.publisso.de/adhoc/uri/SmFlZ2VyLCBBLg==|https://frl.publisso.de/adhoc/uri/TG9yZW56LCBFLg==|https://frl.publisso.de/adhoc/uri/QWRlZ25pa2EsIEEuIEEu|https://frl.publisso.de/adhoc/uri/SG9ua3BlaGVkamksIFkuIEou|https://frl.publisso.de/adhoc/uri/RGVqb24tQWdvYmUsIEouIEMu|https://frl.publisso.de/adhoc/uri/TWJhLCBSLiBCZWg=|https://frl.publisso.de/adhoc/uri/Tmd3ZXNlLCBNLiBNYm9uZw==|https://frl.publisso.de/adhoc/uri/TWFsb3VtLCBNLiBOemFtYmE=|https://frl.publisso.de/adhoc/uri/TW91cmUsIEEuIE5ndWVtYQ==|https://frl.publisso.de/adhoc/uri/TWV1bGFoLCBCLiBULg==|https://frl.publisso.de/adhoc/uri/UmFrb3RvemFuZHJpbmRyYWlueSwgUi4=|https://frl.publisso.de/adhoc/uri/UmFrb3RvemFuZHJpbmRyYWlueSwgTi4=|https://frl.publisso.de/adhoc/uri/U29sb25pcmluYSwgTS4gSi4=|https://frl.publisso.de/adhoc/uri/UmFuZHJpYW1hbmlhcmEsIEou|https://frl.publisso.de/adhoc/uri/UmFrb3RvYXJpdmVsbywgUi4gQS4=|https://frl.publisso.de/adhoc/uri/UmFsYWl6YW5kcnksIEEu|https://frl.publisso.de/adhoc/uri/UmFkb21hbmFuYSwgTS4=|https://frl.publisso.de/adhoc/uri/QW5kcmlhbmFyaXZlbG8sIE0uIFJha290bw==|https://frl.publisso.de/adhoc/uri/UmFzYW1vZWxpbmEsIFQu|https://frl.publisso.de/adhoc/uri/UmF6YWZpbmRyYWtvdG8sIFIu|https://frl.publisso.de/adhoc/uri/U2ljaXJ1LCBFLg==|https://frl.publisso.de/adhoc/uri/QWVydHMsIEMu
1000 Hinweis
  • DeepGreen-ID: 33b9c08e913041ca9b65ebb81a393b78 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
1000 Label
1000 Dateien
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6464537.rdf
1000 Erstellt am 2023-11-16T04:55:38.319+0100
1000 Erstellt von 322
1000 beschreibt frl:6464537
1000 Zuletzt bearbeitet Fri Dec 01 00:11:04 CET 2023
1000 Objekt bearb. Fri Dec 01 00:11:04 CET 2023
1000 Vgl. frl:6464537
1000 Oai Id
  1. oai:frl.publisso.de:frl:6464537 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

View source