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

NCT03511443 | Unknown DMC

• 2 other identifiers: HP-00076579Pro00089928
• Study Type: interventional
• Target: 1,980
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria Diagnosis; Malaria,Falciparum

Keywords

hsRDT; usRDT; Reactive Case Detection (RCD); High risk for malaria

Outcome Measures

Primary Outcomes (1)

• Prevalence of malaria infections identified by the new hsRDT

  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 Outcomes (3)

• Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections

  Outcomes will be analyzed after 10 months of data collection

• Correlation of detection capability between cRDT and hsRDT

  PCR results will be analyzed during month 10

• Risk factors associated with malaria infection cases

  Outcome will be measured/analyzed in month 10, after PCR results are released

Study Arms (1)

Diagnostic performance of hsRDT

OTHER

Comparing diagnostic power of two diagnostics

Diagnostic Test: hsRDT

Interventions

hsRDT DIAGNOSTIC_TEST

Testing highly sensitive RDT detection for low parasitemia

Also known as: Highly sensitive RDT is also used as ultrasensitive RDT

Diagnostic performance of hsRDT

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of severe clinical illness including severe malaria
• Non-resident index cases
• Refusal to participate in the study

Sponsors & Collaborators

• University Research Co, LLC: lead
• Duke University: collaborator
• United States Agency for International Development (USAID): collaborator
• Department of Medical Research, Lower Myanmar: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University Research Co., LLC (URC)

Yangon, Burma

RECRUITING

Related Publications (10)

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  PMID: 26783752 BACKGROUND

• 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.

  PMID: 21311588 BACKGROUND

• 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.

  PMID: 26701778 BACKGROUND

• 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.

  PMID: 25964304 BACKGROUND

• 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.

  PMID: 19848588 BACKGROUND

• 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.

  PMID: 24989601 BACKGROUND

• 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.

  PMID: 26424000 BACKGROUND

• 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.

  PMID: 23940677 BACKGROUND

• 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.

  PMID: 26852118 BACKGROUND

• 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.

  PMID: 26931488 BACKGROUND

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Saw Lwin, MD

  University Research Co, LLC

  STUDY CHAIR

• Feliciano Monti, MD

  US Embassy, Yangon

  STUDY CHAIR

Central Study Contacts

San Kyawt Khine, MD

CONTACT

959450542076; skkhine.khine75@gmail.com

Kyaw Myint Tun, MD

CONTACT

9595039861; ktun@urc-chs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 27, 2018
• Study Start: October 2, 2017
• Primary Completion: June 28, 2018
• Study Completion: October 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

BU (1)