Clinical trial NCT03511443: Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria Diagnosis
Malaria,Falciparum
Keywords: hsRDT
usRDT
Reactive Case Detection (RCD)
High risk for malaria
Lead sponsor: University Research Co, LLC
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: United States Agency for International Development (USAID)
name: Department of Medical Research, Lower Myanmar
name: Centers for Disease Control and Prevention
First posted: 2018-04-27
Enrollment: 1980
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of malaria infections identified by the new hsRDT
timeFrame: PCR diagnosis of samples will occur after 10 months of data collection.
Secondary outcomes:
measure: Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections
timeFrame: Outcomes will be analyzed after 10 months of data collection
measure: Correlation of detection capability between cRDT and hsRDT
timeFrame: PCR results will be analyzed during month 10
measure: Risk factors associated with malaria infection cases
timeFrame: Outcome will be measured/analyzed in month 10, after PCR results are released
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: University Research Co., LLC (URC)
Study officials:
affiliation: University Research Co, LLC
name: Saw Lwin, MD
role: STUDY_CHAIR
affiliation: US Embassy, Yangon
name: Feliciano Monti, MD
role: STUDY_CHAIR
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