Malaria,Falciparum Clinical Trial
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
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.
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.
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