PROMISE (Placental malaria: Recognition Of host potential biomarkers associated with the dISEase)

Not Applicable

Conditions: Malaria

Registration Number: PACTR202407739257214

Lead Sponsor: Clinical Research Unit of Nanoro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Only samples that meet the following criteria will be included in the current study:
-The donor pregnant woman signed an informed consent authorizing the further use of their samples in studies of malaria and other infectious diseases.
-Availability of subsequent samples from the same individual at Days 0, 28, 63;

Exclusion Criteria

-Absence of clinical data related to the samples;
-Absence of placenta biopsy for analysis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy:<br>- Sensitivity and Specificity: Assess the sensitivity, specificity, and predictive value of IL-10, sTNF-RII, antibodies to DBL5, C5a, and VEGF in detecting PM using plasma samples.<br>- Biomarker Performance Dataset: Compile data on biomarker performance to identify the most accurate candidates for inclusion in a future diagnostic platform.

Secondary Outcome Measures

Name	Time	Method
Biomarker Variability:<br>- Stage of Pregnancy: Analyze how biomarker levels vary across different stages of pregnancy to ensure they consistently detect PM.<br>- Anti-malarial Treatments: Conduct a stratified analysis to observe biomarker variations across different anti-malarial treatments.;Integration with Intervention Strategies:<br>- Enhance Effectiveness: Evaluate how the validated biomarkers can be incorporated with existing intervention strategies to improve their overall effectiveness in combating PM.;Conceptual Framework:<br>- Diagnostic Tool Development: Create a prototype of a user-friendly, accurate, and feasible diagnostic tool suitable for resource-limited settings using the most promising biomarkers.;Temporal Dynamics:<br>- Biomarker Levels: Track changes in biomarker levels at specific time points (days 0, 28, and 63) during pregnancy to understand their temporal dynamics in relation to PM.