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

NCT06572644 | Completed

• 1 other identifier: INSP_CM_09_2022
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria,Falciparum

Keywords

Pregnancy; Malaria; Performance; Ultrasensible rapid diagnostic test; Burkina Faso

Outcome Measures

Primary Outcomes (2)

• Sensitivity of HS_RDT

  It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR).

  At baseline

• Specificity of HS_RDT

  It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR).

  At baseline

Secondary Outcomes (4)

• Positive predictive value

  At baseline

• Negative predictive value

  At baseline

• The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants

  At baseline

• Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia

  30 days after uptake of IPTp-SP

Other Outcomes (2)

• Prevalence of anaemia

  At baseline

• Prevalence of Pfdhfr & Pfhdps mutations

  At baseline

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women attending their ANC visits at the Centre Médical Urbain de Lafiabougou

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre MURAZ/Institut National de Santé Publique: lead
• University of Ghana: collaborator

Study Sites (1)

Centre Médical Urbain de Lafiabougou

Bobo-Dioulasso, Houet, 390, Burkina Faso

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots were collected at enrolment and one month after sulfadoxine-pyrimethamine uptake.

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Mamoudou Cissé, MD, PhD

  Centre MURAZ/Institut National de Santé Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Parasitology and Mycology

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: October 11, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 31, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

BU (1)