Clinical trial NCT06572644: Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso
Official title: Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria,Falciparum
Keywords: Pregnancy
Malaria
Performance
Ultrasensible rapid diagnostic test
Burkina Faso
Lead sponsor: Centre MURAZ/Institut National de Santé Publique
Sponsor class: OTHER_GOV
Collaborators: name: University of Ghana
First posted: 2024-08-27
Enrollment: 288
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending their ANC visits at the Centre Médical Urbain de Lafiabougou

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.

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.

Primary outcomes:
measure: Sensitivity of HS_RDT
timeFrame: At baseline
measure: Specificity of HS_RDT
timeFrame: At baseline
Secondary outcomes:
measure: Positive predictive value
timeFrame: At baseline
measure: Negative predictive value
timeFrame: At baseline
measure: The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants
timeFrame: At baseline
measure: Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia
timeFrame: 30 days after uptake of IPTp-SP
Other outcomes:
measure: Prevalence of anaemia
timeFrame: At baseline
measure: Prevalence of Pfdhfr & Pfhdps mutations
timeFrame: At baseline
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre Médical Urbain de Lafiabougou
state: Houet
Study officials:
affiliation: Centre MURAZ/Institut National de Santé Publique
name: Mamoudou Cissé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: