- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511443
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Yangon, Myanmar
- Recruiting
- University Research Co., LLC (URC)
-
Contact:
- Kyaw Myint Tun
- Phone Number: 9595039861
- Email: ktun@urc-chs.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Diagnostic performance of hsRDT
Comparing diagnostic power of two diagnostics
|
Testing highly sensitive RDT detection for low parasitemia
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
PCR diagnosis of samples will occur after 10 months of data collection.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Outcomes will be analyzed after 10 months of data collection
|
Correlation of detection capability between cRDT and hsRDT
Time Frame: PCR results will be analyzed during month 10
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Outcomes measured by correlation of test positivity rates
|
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
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Outcomes will be measured by relative risk of malaria in association with different risk factors identified
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Outcome will be measured/analyzed in month 10, after PCR results are released
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Saw Lwin, MD, University Research Co, LLC
- Study Chair: Feliciano Monti, MD, US Embassy, Yangon
Publications and helpful links
General Publications
- Chen I, Clarke SE, Gosling R, Hamainza B, Killeen G, Magill A, O'Meara W, Price RN, Riley EM. "Asymptomatic" Malaria: A Chronic and Debilitating Infection That Should Be Treated. PLoS Med. 2016 Jan 19;13(1):e1001942. doi: 10.1371/journal.pmed.1001942. eCollection 2016 Jan.
- malERA Consultative Group on Health Systems and Operational Research. A research agenda for malaria eradication: health systems and operational research. PLoS Med. 2011 Jan 25;8(1):e1000397. doi: 10.1371/journal.pmed.1000397.
- Adams M, Joshi SN, Mbambo G, Mu AZ, Roemmich SM, Shrestha B, Strauss KA, Johnson NE, Oo KZ, Hlaing TM, Han ZY, Han KT, Thura S, Richards AK, Huang F, Nyunt MM, Plowe CV. An ultrasensitive reverse transcription polymerase chain reaction assay to detect asymptomatic low-density Plasmodium falciparum and Plasmodium vivax infections in small volume blood samples. Malar J. 2015 Dec 23;14:520. doi: 10.1186/s12936-015-1038-z.
- Cheng Z, Wang D, Tian X, Sun Y, Sun X, Xiao N, Zheng Z. Capture and Ligation Probe-PCR (CLIP-PCR) for Molecular Screening, with Application to Active Malaria Surveillance for Elimination. Clin Chem. 2015 Jun;61(6):821-8. doi: 10.1373/clinchem.2014.237115. Epub 2015 May 11.
- Okell LC, Ghani AC, Lyons E, Drakeley CJ. Submicroscopic infection in Plasmodium falciparum-endemic populations: a systematic review and meta-analysis. J Infect Dis. 2009 Nov 15;200(10):1509-17. doi: 10.1086/644781.
- Imwong M, Hanchana S, Malleret B, Renia L, Day NP, Dondorp A, Nosten F, Snounou G, White NJ. High-throughput ultrasensitive molecular techniques for quantifying low-density malaria parasitemias. J Clin Microbiol. 2014 Sep;52(9):3303-9. doi: 10.1128/JCM.01057-14. Epub 2014 Jul 2.
- Imwong M, Nguyen TN, Tripura R, Peto TJ, Lee SJ, Lwin KM, Suangkanarat P, Jeeyapant A, Vihokhern B, Wongsaen K, Van Hue D, Dong le T, Nguyen TU, Lubell Y, von Seidlein L, Dhorda M, Promnarate C, Snounou G, Malleret B, Renia L, Keereecharoen L, Singhasivanon P, Sirithiranont P, Chalk J, Nguon C, Hien TT, Day N, White NJ, Dondorp A, Nosten F. The epidemiology of subclinical malaria infections in South-East Asia: findings from cross-sectional surveys in Thailand-Myanmar border areas, Cambodia, and Vietnam. Malar J. 2015 Sep 30;14:381. doi: 10.1186/s12936-015-0906-x.
- Searle KM, Shields T, Hamapumbu H, Kobayashi T, Mharakurwa S, Thuma PE, Smith DL, Glass G, Moss WJ. Efficiency of household reactive case detection for malaria in rural Southern Zambia: simulations based on cross-sectional surveys from two epidemiological settings. PLoS One. 2013 Aug 6;8(8):e70972. doi: 10.1371/journal.pone.0070972. Print 2013.
- van Eijk AM, Ramanathapuram L, Sutton PL, Kanagaraj D, Sri Lakshmi Priya G, Ravishankaran S, Asokan A, Tandel N, Patel A, Desai N, Singh R, Sullivan SA, Carlton JM, Srivastava HC, Eapen A. What is the value of reactive case detection in malaria control? A case-study in India and a systematic review. Malar J. 2016 Feb 6;15:67. doi: 10.1186/s12936-016-1120-1.
- Hustedt J, Canavati SE, Rang C, Ashton RA, Khim N, Berne L, Kim S, Sovannaroth S, Ly P, Menard D, Cox J, Meek S, Roca-Feltrer A. Reactive case-detection of malaria in Pailin Province, Western Cambodia: lessons from a year-long evaluation in a pre-elimination setting. Malar J. 2016 Mar 1;15:132. doi: 10.1186/s12936-016-1191-z.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00076579
- Pro00089928 (OTHER: Duke University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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