Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Duke University

Status: Completed

Conditions: Plasmodium Knowlesi Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03988296

Pro00102072

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.