An interventional study of hsRDT in Malaria Diagnosis and Malaria,Falciparum, sponsored by University Research Co, LLC. Status unknown at 1 site in Myanmar. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-27.
Sponsored by University Research Co, LLC · Not applicable, Interventional, and Diagnostic
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
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.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 1,980 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →This is the only study on the registry with University Research Co, LLC as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparing diagnostic power of two diagnostics
Diagnostic Test: hsRDT
Testing highly sensitive RDT detection for low parasitemia
Also known as: Highly sensitive RDT is also used as ultrasensitive RDT
Prevalence of malaria infections identified by the new hsRDT
Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively
Time frame: PCR diagnosis of samples will occur after 10 months of data collection.
Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections
Outcomes measured between hsRDT and cRDT
Time frame: Outcomes will be analyzed after 10 months of data collection
Correlation of detection capability between cRDT and hsRDT
Outcomes measured by correlation of test positivity rates
Time frame: PCR results will be analyzed during month 10
Risk factors associated with malaria infection cases
Outcomes will be measured by relative risk of malaria in association with different risk factors identified
Time frame: Outcome will be measured/analyzed in month 10, after PCR results are released
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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