Plasmodium Falciparum MalariaNCT03462615
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
An observational study of Plasmodium Falciparum Malaria and Pregnancy Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Papua New Guinea.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Plasmodium Falciparum Malaria, Pregnancy Malaria, Diagnoses Disease
- What is being tested?
- HS-RDT
- How many people
- 930 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 15 Aug 2018to 30 May 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Child, Adult, Older adult
Study population: The study will test samples from pregnant women aged 16 and older, self-presenting at health centres for antenatal care in this malaria-endemic setting
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Nonga General Hospital
Rabaul, East New Britain Province
About this study
Official title: Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women in Papua New Guinea
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
- Being tested
- HS-RDT
- Keywords
- malaria, pregnancy, diagnosis, rapid diagnostic test
- Medical subject headings
- Malaria, Falciparum, Malaria, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-RDTDiagnostic test
Also called ultra sensitive 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, negative predictive value and positive predictive value
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start15 Aug 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Burnet Institute, Papua New Guinea Institute of Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462615
- Sponsor's protocol ID
- 7815-2/2
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2018
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No