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Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women (HSRDT MiP)

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ClinicalTrials.gov Identifier: NCT03172221
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:
This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

Condition or disease Intervention/treatment
Plasmodium Falciparum Pregnancy Malaria Diagnoses Disease Diagnostic Test: HS-RDT

Detailed Description:
The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.

Study Type : Observational
Estimated Enrollment : 1710 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : December 24, 2017
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria


Intervention Details:
  • Diagnostic Test: HS-RDT
    A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.
    Other Name: ultrasensitive RDT


Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 1 year ]
    Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study will include pregnant women
Sampling Method:   Non-Probability Sample
Study Population
Consecutive pregnant women self-presenting at the selected health care facilities and meeting the eligibility criteria will be invited to participate in the study. After study staff provides full information about the study, pregnant women willing to participate will be asked to sign the informed consent form. They will consent to be interviewed and to provide finger-prick blood. For women younger than 18 years old, additional approval from the parent or legal guardian will be needed if required by local Institutional Review Board (IRB). Participants will be invited to participate at any visit at any trimester.
Criteria

Inclusion Criteria:

  • Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
  • Resident for at least 1 year in the study site
  • Age ≥ 15
  • Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age < 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
  • Willingness to provide finger-prick blood sample at enrolment

Exclusion Criteria:

  • Past history of malaria and/or antimalarial drugs in the last three months
  • Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
  • Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
  • Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172221


Contacts
Contact: Ana Campillo, PhD +41 (0) 22 749 19 23 ana.campillo@finddx.org
Contact: Iveth González, PhD Iveth.Gonzalez@finddx.org

Locations
Colombia
Centro de Salud el Reposo Recruiting
Quibdó, Colombia
Contact: Ana María Vásquez, Ph.D.       amaria.vasquez@udea.edu.co   
Hospital Divino Nino Recruiting
Tumaco, Colombia
Contact: Ana María Vásquez       amaria.vasquez@udea.edu.co   
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Universidad de Antioquia

Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03172221     History of Changes
Other Study ID Numbers: 7815-2/1
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
malaria
pregnancy
diagnosis
low-transmission
Plasmodium falciparum
rapid diagnostic test

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases