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
|Condition or disease||Intervention/treatment||Phase|
|Malaria Diagnosis Malaria,Falciparum||Diagnostic Test: hsRDT||Not Applicable|
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.
- 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)|
|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|
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
- 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
- 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
- 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
- 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
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
|Contact: San Kyawt Khine, MDfirstname.lastname@example.org|
|Contact: Kyaw Myint Tun, MDemail@example.com|
|University Research Co., LLC (URC)||Recruiting|
|Contact: Kyaw Myint Tun 9595039861 firstname.lastname@example.org|
|Study Chair:||Saw Lwin, MD||University Research Co, LLC|
|Study Chair:||Feliciano Monti, MD||US Embassy, Yangon|