Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

880 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Plasmodium Falciparum Pregnancy Malaria Diagnoses Disease

Keywords

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malaria pregnancy diagnosis low-transmission Plasmodium falciparum rapid diagnostic test

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ultrasensitive RDT

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro de Salud el Reposo

Quibdó, , Colombia

Site Status

Hospital Divino Nino

Tumaco, , Colombia

Site Status

Countries

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Colombia

References

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Vasquez AM, Velez G, Medina A, Serra-Casas E, Campillo A, Gonzalez IJ, Murphy SC, Seilie AM, Ding XC, Tobon Castano A. Evaluation of highly sensitive diagnostic tools for the detection of P. falciparum in pregnant women attending antenatal care visits in Colombia. BMC Pregnancy Childbirth. 2020 Jul 31;20(1):440. doi: 10.1186/s12884-020-03114-4.

Reference Type DERIVED

PMID: 32736543 (View on PubMed)

Other Identifiers

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7815-2/1

Identifier Type: -

Identifier Source: org_study_id