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Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03988296
Enrollment
116
Registered
2019-06-17
Start date
2019-06-11
Completion date
2019-08-22
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Knowlesi Infection

Keywords

Monkey malaria

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with a possible diagnosis of malaria10 weeksPossible diagnosis of malaria as defined in accordance with the inclusion and exclusion criteria. Giemsa-stained thick and thin smears will be prepared for verification of parasitaemia by microscopy in the respective hospital laboratories

Secondary

MeasureTime frameDescription
Statistical association between risk factors and diagnostic assays results.10 weeksA brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026