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

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03462615
• Other study ID #: 7815-2/2
• Status: Not yet recruiting
• Phase: N/A
• First received: March 6, 2018
• Last updated: March 6, 2018
• Start date: April 2018
• Est. completion date: October 2018

Study information

• Verified date: March 2018
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth.

The Bill & Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy.

The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 930
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All women must meet all the following inclusion criteria in order to be eligible to participate in the study:

• Pregnant women attending first antenatal care visit at selected health facilities

• Resident in the study area for at least 1 year prior to enrolment

• Age = 16

• Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness)

• Willing to provide finger-prick blood sample

Exclusion Criteria:

• Women meeting any of the following exclusion criteria at screening will be excluded from study participation:

• History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record

• Presence of severe malaria as defined by WHO guidelines at the moment of recruitment.

Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines

Related Conditions & MeSH terms

• Diagnoses Disease
• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria
• 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
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Burnet Institute, Papua New Guinea Institute of Medical Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	1.1 Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and LAMP in peripheral blood with qPCR as reference test.	1 year