Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407739257214 Date of Approval: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PROMISE (Placental malaria: Recognition Of host potential biomarkers associated with the dISEase)
Official scientific title Placental malaria: identification of host potential biomarkers associated with the disease
Brief summary describing the background and objectives of the trial Placental malaria (PM) poses significant health risks, including maternal anaemia, premature delivery, and low birth weight. Early detection of PM is challenging due to the lack of reliable diagnostic methods during pregnancy. Recent studies suggest that certain immunological biomarkers—such as IL-10, sTNF-RII, antibodies to DBL5, C5a, and VEGF—could serve as early indicators of PM. Objectives: Primary Objectives: Evaluate Biomarkers: Assess the precision and reliability of identified biomarkers (IL-10, sTNF-RII, antibodies to DBL5, C5a, and VEGF) in detecting PM during pregnancy. Develop a Diagnostic Platform: Use evaluation data to develop an ELISA-based diagnostic platform incorporating the most accurate biomarker data. Secondary Objectives: Stage-Specific Reliability: Investigate how the effectiveness of biomarkers varies across pregnancy stages. Intervention Integration: Combine biomarker findings with existing intervention strategies. Stratified Analysis: Enhance precision in detecting biomarker variations across different anti-malarial treatments. Study Design: Conducted in Burkina Faso, the study will involve 100 pregnant women (50 with PM and 50 without). Plasma samples will be collected at days 0, 28, and 63 to validate biomarker accuracy. The study aims to develop a reliable diagnostic tool for early PM detection, improving maternal and infant health outcomes in malaria-endemic areas.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) PROMISE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2024
Actual trial start date
Anticipated date of last follow up 01/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PM Positive Not applicable Not applicable Pregnant women were recruited based on their malaria infection status and treated with an antimalarial drug. At delivery, their placenta will be diagnosed for placenta malaria 50
Control Group PM Negative Not applicable Delivery These women were selected in the same condition, but they were passively followed up during the study. At delivery, their placenta was also diagnosed for placental malaria 50 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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; - Absence of clinical data related to the samples; - Absence of placenta biopsy for analysis. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 43 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/08/2024 CERS
Ethics Committee Address
Street address City Postal code Country
Rue Home Kisito Ouagadougou 10020 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnostic Accuracy: - 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. - Biomarker Performance Dataset: Compile data on biomarker performance to identify the most accurate candidates for inclusion in a future diagnostic platform. Days 0, 28 and 63
Secondary Outcome Biomarker Variability: - Stage of Pregnancy: Analyze how biomarker levels vary across different stages of pregnancy to ensure they consistently detect PM. - Anti-malarial Treatments: Conduct a stratified analysis to observe biomarker variations across different anti-malarial treatments. Days 0, 28 and 63
Secondary Outcome Integration with Intervention Strategies: - Enhance Effectiveness: Evaluate how the validated biomarkers can be incorporated with existing intervention strategies to improve their overall effectiveness in combating PM. Delivery
Secondary Outcome Conceptual Framework: - 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. Delivery
Secondary Outcome Temporal Dynamics: - 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. Days 0, 28, and 63
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinical Research Unit of Nanoro Not Applicable Koudougou 40000 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
GSK 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinical Research Unit of Nanoro 2, Avenue Kumda, Yonre Ouagadougou 10020 Burkina Faso Governmental research center
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ousmane Traore ousmane.traore@crun.bf +22674141422 42, Avenue Kumda-Yonre
City Postal code Country Position/Affiliation
Ouagadougou 10020 Burkina Faso Research Fellow with Permanent position
Role Name Email Phone Street address
Scientific Enquiries Halidou Tinto tintoh@crun.bf +22670346354 42, Avenue Kumda-Yonre,
City Postal code Country Position/Affiliation
Ouagadougou 10020 Burkina Faso Director of CRUN
Role Name Email Phone Street address
Public Enquiries Ousmane Traore ousmane.traore@crun.bf +22674141422 42, Avenue Kumda-Yonre
City Postal code Country Position/Affiliation
Ouagadougou 10020 Burkina Faso Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Sharing Policy: The study protocol includes a clear plan for sharing individual participant data (IPD) to promote transparency and further research in the field of placental malaria diagnostics. Data to be Shared: - Type of Data: De-identified individual participant data, including clinical data and biomarker levels (IL-10, sTNF-RII, antibodies to DBL5, C5a, and VEGF) collected at days 0, 28, and 63. - Supporting Information: Study protocol, statistical analysis plan, informed consent form, and analytical methods. Access and Distribution: - Availability: Data will be available to researchers upon reasonable request. - Access Criteria: Researchers must provide a methodologically sound proposal, approved by an independent ethics committee. - Request Process: Requests should be submitted to the Principal Investigator, Dr. Ousmane TRAORE (ousmane.traore@crun.bf), with a detailed proposal and intended use of the data. - Timeline: Data will be available from the second trimester of the first year of the project until the end of the study. Security and Confidentiality: - Anonymization: All shared data will be de-identified to protect participant privacy. - Data Storage: Data will be securely stored in a server managed by the Clinical Research Unit of Nanoro (CRUN-IRSS), with access limited to authorized personnel. - Data Transfer: Any data transfer will adhere to strict confidentiality protocols, and no personal identifiers will be shared. Ethical Considerations: - Consent: Participants have provided informed consent for their data to be used in future research related to malaria and other infectious diseases. - Oversight: Data sharing will comply with ethical guidelines and approvals from the relevant Institutional Review Board (IRB). Usage Restrictions: - Non-Commercial Use: Data must be used for non-commercial research purposes only. - Publication: Researchers using the data must acknowledge the original study and its contributors in any resulting publications. Study Protocol 3 years Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information