MedTrace Logo

Additional Screening With Sensitives RDTs and Malaria

NCT04147546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2023-03-30

No results posted yet for this study

Summary

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For the latter, 3 or more doses are recommended by the national malaria control program (NMCP) but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by perceptions, acceptability and contextual factors that need to be understood and therefore improve the effectiveness of this health interventions. In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many malaria cases are missed in pregnant women due to the power performance of recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT could improve the outcome of the pregnancy in addition to IPTp-SP.

Conditions

  • Plasmodium Falciparum Malaria
  • Malaria Diagnosis

Interventions

DIAGNOSTIC_TEST

Additional screening using ultra sensitive RDTs

At each ANC visit, study nurses will perform an HS-RDT for participants in the intervention arm

DRUG

Dihydroartemisinin-piperaquin

All pregnant women with a positive HS-RDT will be treated with a full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home

OTHER

Reminders

Before each scheduled ANC visit, reminders using SMS or phone call will be used. This is order to increase ANC attendance

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-08-31
Completion
2021-12-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147546 on ClinicalTrials.gov