Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Completed

• Conditions: Plasmodium Knowlesi Infection

• Registration Number: NCT03988296
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-11
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with a possible diagnosis of malaria	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 Outcome Measures

Name	Time	Method
Statistical association between risk factors and diagnostic assays results.	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

Trial Locations

Locations (3)

Kapit Hospital; 🇲🇾 Kapit, Sarawak, Malaysia

Sarikei Hospital; 🇲🇾 Sarikei, Sarawak, Malaysia

Sibu Hospital; 🇲🇾 Sibu, Sarawak, Malaysia