Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections

Sponsor
University Research Co, LLC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03511443
Collaborator
Duke University (Other), United States Agency for International Development (USAID) (U.S. Fed), Department of Medical Research, Lower Myanmar (Other), Centers for Disease Control and Prevention (U.S. Fed)
1,980
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
165.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: hsRDT
N/A

Detailed Description

The study is conducted in the areas under Sakhanmaw Rural Health Center, Ann Township in Southern Rakhine State, Myanmar.

General objective was to evaluate the performance of the new highly-sensitive rapid diagnostic test (RDT) developed by SD Bioline versus conventional RDT, compared with PCR as the gold standard, in reactive case detection of malaria infections in Rakhine State, Myanmar.

Specific objectives

  • To evaluate the prevalence of malaria identified by the new hsRDT in comparison with that by cRDT and PCR

  • To assess the diagnostic performance characteristics of hsRDT versus cRDT, using PCR as gold standard, in the detection of P.falciparum infections

  • To evaluate correlation of detection capability between cRDT and hsRDT

  • To identify risk factors associated with malaria infection, including but not limited to, socio-demographic factors and travel history related with malaria index cases

This is a prospective community-based single-center reactive case detection (RCD) study to assess the performance of hsRDT versus cRDT in identifying individuals with malaria infection ("Secondary case") in a population living and/or working in a close physical proximity to an "index case." All cases parasitologically confirmed by conventional RDT will be promptly notified to the study team and interviewed with a standardized case investigation form at their home, possibly within 3 days. All members of the primary case household and those of the nearest 10 households, aged 5 years and above, will be invited to participate in the study. A blood spot will be collected for subsequent PCR analysis. At least 50 index cases are targeted for investigation and reactive case detection and an estimated number of 1,980 persons will be involved in the study.

It is expected that this study will be an important input for the national malaria control program in Myanmar as they develop the strategies to conduct reactive case detection.

A suitable statistical software, e.g. STATA will be used to analyze the data resulting from the participant interviews and 3 parasitological tests. Logistic regression models will be developed to examine factors significantly associated with malaria infections.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1980 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
If P.f malaria case were detected, the responsible malaria worker or basic health staff will inform to survey team and blood samples for cRDT, hsRDT, Dried Blood Spot for PCR will be collected from index case and contacts (nearby 10-household members and peers). Then the results of cRDT and hsRDT will be confirmed by PCR for evaluating their performance. Then the applicability of hsRDT to detect low parasitaemia for enhancing malaria elimination activities will be evaluated.If P.f malaria case were detected, the responsible malaria worker or basic health staff will inform to survey team and blood samples for cRDT, hsRDT, Dried Blood Spot for PCR will be collected from index case and contacts (nearby 10-household members and peers). Then the results of cRDT and hsRDT will be confirmed by PCR for evaluating their performance. Then the applicability of hsRDT to detect low parasitaemia for enhancing malaria elimination activities will be evaluated.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of the Performance of a Highly-sensitive Rapid Diagnostic Test (RDT) Versus Conventional RDT, Compared With PCR as the Gold Standard, in Reactive Case Detection of Malaria Infections in Rakhine State, Myanmar
Actual Study Start Date :
Oct 2, 2017
Anticipated Primary Completion Date :
Jun 28, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

ArmIntervention/Treatment
Other: Diagnostic performance of hsRDT

Comparing diagnostic power of two diagnostics

Diagnostic Test: hsRDT
Testing highly sensitive RDT detection for low parasitemia
Other Names:
  • Highly sensitive RDT is also used as ultrasensitive RDT
  • Outcome Measures

    Primary Outcome Measures

    1. Prevalence of malaria infections identified by the new hsRDT [PCR diagnosis of samples will occur after 10 months of data collection.]

      Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively

    Secondary Outcome Measures

    1. Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections [Outcomes will be analyzed after 10 months of data collection]

      Outcomes measured between hsRDT and cRDT

    2. Correlation of detection capability between cRDT and hsRDT [PCR results will be analyzed during month 10]

      Outcomes measured by correlation of test positivity rates

    3. Risk factors associated with malaria infection cases [Outcome will be measured/analyzed in month 10, after PCR results are released]

      Outcomes will be measured by relative risk of malaria in association with different risk factors identified

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age at least 5 years old

    • Resident of the villages, or temporary visitors, or co-workers or co-travelers of index case

    • Willingness to participate in the study evident by informed consent

    Exclusion Criteria:
    • Presence of severe clinical illness including severe malaria

    • Non-resident index cases

    • Refusal to participate in the study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University Research Co., LLC (URC)YangonMyanmar

    Sponsors and Collaborators

    • University Research Co, LLC
    • Duke University
    • United States Agency for International Development (USAID)
    • Department of Medical Research, Lower Myanmar
    • Centers for Disease Control and Prevention

    Investigators

    • Study Chair: Saw Lwin, MD, University Research Co, LLC
    • Study Chair: Feliciano Monti, MD, US Embassy, Yangon

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University Research Co, LLC
    ClinicalTrials.gov Identifier:
    NCT03511443
    Other Study ID Numbers:
    • HP-00076579
    • Pro00089928
    First Posted:
    Apr 27, 2018
    Last Update Posted:
    Apr 27, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Research Co, LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2018