NCT Number: NCT03988296
Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi
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.
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Conditions
Age range
7 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Kapit Hospital, Kapit, Sarawak, Malaysia
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Number of patients with a possible diagnosis of malaria
Time frame: 10 weeks
Possible 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 outcomes
-
Statistical association between risk factors and diagnostic assays results.
Time frame: 10 weeks
A brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined
Sponsors and collaborators
Lead sponsor
Duke University
Other
Registry information
Official study title
Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
Important dates
- Study start
- 2019
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jun 17, 2019
- Registry last updated
- Oct 2, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.