Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal)
The malaria parasite <i>Plasmodium falciparum</i> (<i>Pf</i>) can sequester in the placenta resulting in low density of peripheral parasitemia and consequently in false negative malaria diagnosis (by microscopy) in pregnant women. Moreover, the use of rapid diagnostic tests (...
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MDPI AG
2022-09-01
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| Series: | Tropical Medicine and Infectious Disease |
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| Online Access: | https://www.mdpi.com/2414-6366/7/9/219 |
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| author | Francois Kiemde Norbert van Dijk Halidou Tinto Hypolite Muhindo-Mavoko Daniel Valia Berenger Kaboré Japhet Kabalu Vivi Maketa Petra Mens Henk Schallig |
| author_facet | Francois Kiemde Norbert van Dijk Halidou Tinto Hypolite Muhindo-Mavoko Daniel Valia Berenger Kaboré Japhet Kabalu Vivi Maketa Petra Mens Henk Schallig |
| author_sort | Francois Kiemde |
| collection | DOAJ |
| description | The malaria parasite <i>Plasmodium falciparum</i> (<i>Pf</i>) can sequester in the placenta resulting in low density of peripheral parasitemia and consequently in false negative malaria diagnosis (by microscopy) in pregnant women. Moreover, the use of rapid diagnostic tests (RDTs) in diagnostic strategies, including those for the detection of a malaria infection during pregnancy, is constrained by either persistent malaria antigen (histidine-rich protein 2; HRP2) after successful treatment, leading to false positive test results, or by false negative results as previously mentioned due to parasite sequestration (which is further exacerbated due to the low limited of detection [LoD] of conventional RDTs) or to HRP2 deletion. Recently, a direct blood polymerase chain reaction combined with a nucleic acid lateral flow immunoassay (dbPCR-NALFIA) has been developed, which circumvents these challenges and has demonstrated its diagnostic potential in phase 1 and 2 studies. The PREG-DIAGMAL trial presented in this manuscript will assess the diagnostic performance of dbPCR-NALFIA for the diagnostic of malaria in pregnant women and its potential to monitor treatment efficacy in these subjects. The work is ancillary embedded in an ongoing EDCTP funded trial, the PyraPreg project (PACTR202011812241529) in which the safety and efficacy of a newly registered Artemisinin-Based Combination (Pyronaridine-Artesunate) is being evaluated in pregnant women. This is a Phase 3 diagnostic evaluation conducted in 2 African countries: Democratic Republic of the Congo (DRC) and Burkina Faso. Pregnant women fulfilling the inclusion criteria of the PyraPreg study will be also invited to participate in the PREG-DIAGMAL study. Diagnostic accuracy will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and reported according to STARD principles. Due to the lack of a 100% specific and sensitive standard diagnostic test for malaria, the sensitivity and specificity of the new test will be compared to the available diagnostic practice in place at the selected settings (microscopy and/or RDT) and to quantitative PCR as the reference test. This phase 3 diagnostic study is designed towards the evaluation of the performance of a new diagnostic tool for the screening of malaria and the monitoring of treatment in pregnant women under real conditions life. If successful, the dbPCR-NALFIA could be a valuable tool to add to the diagnostic arsenal for malaria, in particular during pregnancy. Trial registration: Pan African Clinical Trial Registry database (PACTR202203780981413). Registered on 17 March 2022. |
| first_indexed | 2024-03-09T22:19:02Z |
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| spelling | doaj.art-3c5454c721d844c589025950d9ffbce02023-11-23T19:17:52ZengMDPI AGTropical Medicine and Infectious Disease2414-63662022-09-017921910.3390/tropicalmed7090219Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal)Francois Kiemde0Norbert van Dijk1Halidou Tinto2Hypolite Muhindo-Mavoko3Daniel Valia4Berenger Kaboré5Japhet Kabalu6Vivi Maketa7Petra Mens8Henk Schallig9Institut de Recherche en Sciences de la Santé—Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro 18, Burkina FasoAmsterdam University Medical Centers, Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Meibergdreef 9, 1105 AZ Amsterdam, The NetherlandsInstitut de Recherche en Sciences de la Santé—Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro 18, Burkina FasoDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa 7948, CongoInstitut de Recherche en Sciences de la Santé—Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro 18, Burkina FasoInstitut de Recherche en Sciences de la Santé—Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro 18, Burkina FasoAmsterdam University Medical Centers, Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Meibergdreef 9, 1105 AZ Amsterdam, The NetherlandsDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa 7948, CongoAmsterdam University Medical Centers, Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Meibergdreef 9, 1105 AZ Amsterdam, The NetherlandsAmsterdam University Medical Centers, Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Meibergdreef 9, 1105 AZ Amsterdam, The NetherlandsThe malaria parasite <i>Plasmodium falciparum</i> (<i>Pf</i>) can sequester in the placenta resulting in low density of peripheral parasitemia and consequently in false negative malaria diagnosis (by microscopy) in pregnant women. Moreover, the use of rapid diagnostic tests (RDTs) in diagnostic strategies, including those for the detection of a malaria infection during pregnancy, is constrained by either persistent malaria antigen (histidine-rich protein 2; HRP2) after successful treatment, leading to false positive test results, or by false negative results as previously mentioned due to parasite sequestration (which is further exacerbated due to the low limited of detection [LoD] of conventional RDTs) or to HRP2 deletion. Recently, a direct blood polymerase chain reaction combined with a nucleic acid lateral flow immunoassay (dbPCR-NALFIA) has been developed, which circumvents these challenges and has demonstrated its diagnostic potential in phase 1 and 2 studies. The PREG-DIAGMAL trial presented in this manuscript will assess the diagnostic performance of dbPCR-NALFIA for the diagnostic of malaria in pregnant women and its potential to monitor treatment efficacy in these subjects. The work is ancillary embedded in an ongoing EDCTP funded trial, the PyraPreg project (PACTR202011812241529) in which the safety and efficacy of a newly registered Artemisinin-Based Combination (Pyronaridine-Artesunate) is being evaluated in pregnant women. This is a Phase 3 diagnostic evaluation conducted in 2 African countries: Democratic Republic of the Congo (DRC) and Burkina Faso. Pregnant women fulfilling the inclusion criteria of the PyraPreg study will be also invited to participate in the PREG-DIAGMAL study. Diagnostic accuracy will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and reported according to STARD principles. Due to the lack of a 100% specific and sensitive standard diagnostic test for malaria, the sensitivity and specificity of the new test will be compared to the available diagnostic practice in place at the selected settings (microscopy and/or RDT) and to quantitative PCR as the reference test. This phase 3 diagnostic study is designed towards the evaluation of the performance of a new diagnostic tool for the screening of malaria and the monitoring of treatment in pregnant women under real conditions life. If successful, the dbPCR-NALFIA could be a valuable tool to add to the diagnostic arsenal for malaria, in particular during pregnancy. Trial registration: Pan African Clinical Trial Registry database (PACTR202203780981413). Registered on 17 March 2022.https://www.mdpi.com/2414-6366/7/9/219malariapregnant womenrapid diagnostic testdb-PCR-NALFIAdiagnosis<i>Plasmodium</i> |
| spellingShingle | Francois Kiemde Norbert van Dijk Halidou Tinto Hypolite Muhindo-Mavoko Daniel Valia Berenger Kaboré Japhet Kabalu Vivi Maketa Petra Mens Henk Schallig Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) Tropical Medicine and Infectious Disease malaria pregnant women rapid diagnostic test db-PCR-NALFIA diagnosis <i>Plasmodium</i> |
| title | Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) |
| title_full | Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) |
| title_fullStr | Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) |
| title_full_unstemmed | Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) |
| title_short | Phase 3 Evaluation of an Innovative Simple Molecular Test for the Diagnosis of Malaria and Follow-Up of Treatment Efficacy in Pregnant Women in Sub-Saharan Africa (Preg-Diagmal) |
| title_sort | phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria and follow up of treatment efficacy in pregnant women in sub saharan africa preg diagmal |
| topic | malaria pregnant women rapid diagnostic test db-PCR-NALFIA diagnosis <i>Plasmodium</i> |
| url | https://www.mdpi.com/2414-6366/7/9/219 |
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