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

Diagnoses Disease Clinical Trial

— HSRDT MiP  

Official title:

Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172221
• Other study ID #: 7815-2/1
• Status: Completed
• Start date: July 25, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: November 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnoses Disease
• Disease
• Malaria
• Plasmodium Falciparum
• Pregnancy Malaria

Intervention

Diagnostic Test:
• HS-RDT
A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.

Locations

Country	Name	City	State
Colombia	Centro de Salud el Reposo	Quibdó
Colombia	Hospital Divino Nino	Tumaco

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	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.	1 year