Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso

NCT ID: NCT06572644

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 288 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is:

• What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS_RDT, the conventional RDT (Co_RDT), microscopy, and qPCR.

Detailed Description

A cross-sectional study including 288 pregnant women was conducted at the Centre médical urbain (CMU) of Lafiabougou located in the periurban area of Bobo-Dioulasso the second largest city of Burkina Faso. Pregnant women attending their ANC visits at the CMU of Lafiabougou were recruited and enrolled into the study if eligible criteria were fulfilled.

At enrolment, an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data (age, educational level, and profession) and history of illness was collected. In addition, obstetric history (parity, gestational age, number of ANC visits, uptake of IPTp-SP) and clinical information (body temperature, weight, height, and arm circumference) were recorded. Thereafter, a venous blood sample (5 mL) was collected to screen for malaria infection (based on HS-RDT, Co_RDT, and thick and thin blood smears), dried blood spots (DBS) (for molecular studies), and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.

After enrolment, only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains. At the end of follow up, a venous blood sample (5 mL) was collected for thick and thin blood smears, DBS, and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.

All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed.

The index tests included HS_RDT (NxTek Eliminate Malaria Pf, product code 05FK140, batch No. 05LDG008B, Alere/Abbott, Republic of Korea), Co_RDT (AdvDxTM Malaria Pf, product code 004ADFEF025KI-2, batch No. ADF77/0222, Advy Chemical, India), and light microscopy.

The ultrasensitive qPCR assay targeting the multicopy conserved var gene acidic terminal sequence (varATS) (Hofmann et al. 2015) was used as gold standard.

Conditions

Malaria,Falciparum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ;
• Provision of informed consent.

Exclusion Criteria

• Past history of malaria or antimalarial drugs within the last 3 months ;
• Having tested positive for malaria by microscopy or RDT in any previous ANC visit ;
• Symptoms and signs of severe malaria as defined by WHO.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Ghana

OTHER

Sponsor Role: collaborator

Centre MURAZ/Institut National de Santé Publique

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mamoudou Cissé

Assistant Professor of Parasitology and Mycology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mamoudou Cissé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre MURAZ/Institut National de Santé Publique

Locations

Centre Médical Urbain de Lafiabougou

Bobo-Dioulasso, Houet, Burkina Faso

Countries

Burkina Faso

Other Identifiers

INSP_CM_09_2022

Identifier Type: -

Identifier Source: org_study_id