Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women

Completed

• Conditions: Pregnancy Malaria; Plasmodium Falciparum; Diagnoses Disease

• Registration Number: NCT03172221
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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 Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-07-25
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 880

Inclusion Criteria

• Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
• Resident for at least 1 year in the study site
• Age ≥ 15
• Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age < 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
• Willingness to provide finger-prick blood sample at enrolment

Exclusion Criteria

• Past history of malaria and/or antimalarial drugs in the last three months
• Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
• Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
• Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	1 year	Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.

Trial Locations

Locations (2)

Centro de Salud el Reposo; 🇨🇴 Quibdó, Colombia

Hospital Divino Nino; 🇨🇴 Tumaco, Colombia