Clinical trial NCT03988296: Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi
Official title: Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Knowlesi Infection
Keywords: Monkey malaria
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 116
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both adults and children \> 7 years old suspected for malaria and meeting inclusion criteria will be eligible to participate. Study subjects will be enrolled at Sarawak Hospitals, both hospitalized and outpatients, using an informed consent process (or assent for children 7-18 years) that permits the completion of a brief questionnaire and collection of a blood sample.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a possible diagnosis of malaria
timeFrame: 10 weeks
Secondary outcomes:
measure: Statistical association between risk factors and diagnostic assays results.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Kapit
country: Malaysia
facility: Kapit Hospital
state: Sarawak
city: Sarikei
country: Malaysia
facility: Sarikei Hospital
state: Sarawak
city: Sibu
country: Malaysia
facility: Sibu Hospital
state: Sarawak
Study officials:
affiliation: Duke University Medical Centre
name: Gregory C. Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.