Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

NCT ID: NCT03988296

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2019-08-22

Brief Summary

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This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.

Detailed Description

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Conditions

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Plasmodium Knowlesi Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours
* Written informed consent is obtained.
* For Children (\>7 to \<18 years): parent or legal guardian provides written informed consent.

Exclusion Criteria

* Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset
* They have a clear alternative diagnosis other than malaria by a trained health care professional.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory C. Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Centre

Locations

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Kapit Hospital

Kapit, Sarawak, Malaysia

Site Status

Sarikei Hospital

Sarikei, Sarawak, Malaysia

Site Status

Sibu Hospital

Sibu, Sarawak, Malaysia

Site Status

Countries

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Malaysia

References

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Richards J, Mueller I. Identifying the risks for human transmission of Plasmodium knowlesi. Lancet Planet Health. 2017 Jun;1(3):e83-e85. doi: 10.1016/S2542-5196(17)30053-0. Epub 2017 Jun 9. No abstract available.

Reference Type BACKGROUND
PMID: 29851611 (View on PubMed)

Imai N, White MT, Ghani AC, Drakeley CJ. Transmission and control of Plasmodium knowlesi: a mathematical modelling study. PLoS Negl Trop Dis. 2014 Jul 24;8(7):e2978. doi: 10.1371/journal.pntd.0002978. eCollection 2014 Jul.

Reference Type BACKGROUND
PMID: 25058400 (View on PubMed)

Singh B, Daneshvar C. Human infections and detection of Plasmodium knowlesi. Clin Microbiol Rev. 2013 Apr;26(2):165-84. doi: 10.1128/CMR.00079-12.

Reference Type BACKGROUND
PMID: 23554413 (View on PubMed)

Singh B, Kim Sung L, Matusop A, Radhakrishnan A, Shamsul SS, Cox-Singh J, Thomas A, Conway DJ. A large focus of naturally acquired Plasmodium knowlesi infections in human beings. Lancet. 2004 Mar 27;363(9414):1017-24. doi: 10.1016/S0140-6736(04)15836-4.

Reference Type BACKGROUND
PMID: 15051281 (View on PubMed)

Barber BE, William T, Grigg MJ, Yeo TW, Anstey NM. Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi. Malar J. 2013 Jan 8;12:8. doi: 10.1186/1475-2875-12-8.

Reference Type BACKGROUND
PMID: 23294844 (View on PubMed)

Komaki-Yasuda K, Vincent JP, Nakatsu M, Kato Y, Ohmagari N, Kano S. A novel PCR-based system for the detection of four species of human malaria parasites and Plasmodium knowlesi. PLoS One. 2018 Jan 25;13(1):e0191886. doi: 10.1371/journal.pone.0191886. eCollection 2018.

Reference Type BACKGROUND
PMID: 29370297 (View on PubMed)

Lucchi NW, Poorak M, Oberstaller J, DeBarry J, Srinivasamoorthy G, Goldman I, Xayavong M, da Silva AJ, Peterson DS, Barnwell JW, Kissinger J, Udhayakumar V. A new single-step PCR assay for the detection of the zoonotic malaria parasite Plasmodium knowlesi. PLoS One. 2012;7(2):e31848. doi: 10.1371/journal.pone.0031848. Epub 2012 Feb 20.

Reference Type BACKGROUND
PMID: 22363751 (View on PubMed)

Lucchi NW, Narayanan J, Karell MA, Xayavong M, Kariuki S, DaSilva AJ, Hill V, Udhayakumar V. Molecular diagnosis of malaria by photo-induced electron transfer fluorogenic primers: PET-PCR. PLoS One. 2013;8(2):e56677. doi: 10.1371/journal.pone.0056677. Epub 2013 Feb 20.

Reference Type BACKGROUND
PMID: 23437209 (View on PubMed)

Other Identifiers

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Pro00102072

Identifier Type: -

Identifier Source: org_study_id

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