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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03511443
• Date of registration: 19/03/2018
• Prospective Registration: No
• Primary sponsor: University Research Co, LLC
• Public title: Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
• Scientific 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
• Date of first enrolment: October 2, 2017
• Target sample size: 1980
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03511443
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Myanmar

Contacts

• Name: San Kyawt Khine, MD

• Name: Saw Lwin, MD
• Affiliation: University Research Co, LLC

• Name: Kyaw Myint Tun

• Name: Feliciano Monti, MD
• Affiliation: US Embassy, Yangon

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria,Falciparum

Malaria Diagnosis

Intervention(s)

Diagnostic Test: hsRDT

Primary Outcome(s)

Prevalence of malaria infections identified by the new hsRDT [Time Frame: PCR diagnosis of samples will occur after 10 months of data collection.]

Secondary Outcome(s)

Correlation of detection capability between cRDT and hsRDT [Time Frame: PCR results will be analyzed during month 10]

Risk factors associated with malaria infection cases [Time Frame: Outcome will be measured/analyzed in month 10, after PCR results are released]

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]

Secondary ID(s)

HP-00076579

Pro00089928

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Department of Medical Research, Lower Myanmar

Duke University

United States Agency for International Development (USAID)

Centers for Disease Control and Prevention