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

U

University Research Co. (URC)

Status

Unknown

Conditions

Malaria Diagnosis
Malaria,Falciparum

Treatments

Diagnostic Test: hsRDT

Study type

Interventional

Funder types

Other
Industry
Other U.S. Federal agency

Identifiers

NCT03511443
HP-00076579
Pro00089928 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,980 estimated patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,980 participants in 1 patient group

Diagnostic performance of hsRDT
Other group
Description:
Comparing diagnostic power of two diagnostics
Treatment:
Diagnostic Test: hsRDT

Trial documents
2

Trial contacts and locations

1

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Central trial contact

San Kyawt Khine, MD; Kyaw Myint Tun, MD

Data sourced from clinicaltrials.gov

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