Viewing Study NCT03172221



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Last Modification Date: 2024-10-26 @ 12:25 PM
Study NCT ID: NCT03172221
Status: COMPLETED
Last Update Posted: 2023-11-30
First Post: 2017-05-29

Brief Title: Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women
Sponsor: Foundation for Innovative New Diagnostics Switzerland
Organization: Foundation for Innovative New Diagnostics Switzerland

Study Overview

Official Title: Clinical Performance of the Histidine Rich Protein 2 HRP2 Highly Sensitive Rapid Diagnostic Test HS-RDT for Malaria Diagnosis in Pregnant Women
Status: COMPLETED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HSRDT MiP
Brief Summary: This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 HRP2 highly sensitive rapid diagnostic test HS-RDT for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia The new HS-RDT will be compared with conventional good quality RDTs microscopy and NAATs loop-mediated isothermal amplification LAMP nested PCR nPCR in peripheral blood samples with quantitative reverse transcription PCR qRT-PCR as reference standard
Detailed Description: The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit Finger-prick blood 300 µL will be collected and used to test for malaria with the HS-RDT as well as with conventional good quality RDTs microscopy and local NAATs LAMP and nPCR Dried blood spots will also be collected for qRT-PCR testing Patient information demographics obstetric history malaria prevention measures etc as well as laboratory results will be recorded and entered into a dedicated database

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None