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

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ClinicalTrials.gov Identifier: NCT03511443
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Duke University
United States Agency for International Development (USAID)
Department of Medical Research, Lower Myanmar
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University Research Co, LLC

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 disease Intervention/treatment Phase
Malaria Diagnosis Malaria,Falciparum Diagnostic Test: hsRDT Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1980 participants
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.
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 : October 2, 2017
Estimated Primary Completion Date : June 28, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Malaria

Arm Intervention/treatment
Diagnostic performance of hsRDT
Comparing diagnostic power of two diagnostics
Diagnostic Test: hsRDT
Testing highly sensitive RDT detection for low parasitemia
Other Name: Highly sensitive RDT is also used as ultrasensitive RDT




Primary Outcome Measures :
  1. Prevalence of malaria infections identified by the new hsRDT [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: PCR results will be analyzed during month 10 ]
    Outcomes measured by correlation of test positivity rates

  3. Risk factors associated with malaria infection cases [ Time Frame: 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



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03511443


Contacts
Contact: San Kyawt Khine, MD 959450542076 skkhine.khine75@gmail.com
Contact: Kyaw Myint Tun, MD 9595039861 ktun@urc-chs.com

Locations
Myanmar
University Research Co., LLC (URC) Recruiting
Yangon, Myanmar
Contact: Kyaw Myint Tun    9595039861    ktun@urc-chs.com   
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)

Documents provided by University Research Co, LLC:
Informed Consent Form  [PDF] June 27, 2017


Publications:

Responsible Party: University Research Co, LLC
ClinicalTrials.gov Identifier: NCT03511443     History of Changes
Other Study ID Numbers: HP-00076579
Pro00089928 ( Other Identifier: Duke University )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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:
hsRDT
usRDT
Reactive Case Detection (RCD)
High risk for malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases