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Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03988296
Collaborator
(none)
116
Enrollment
3
Locations
2.4
Actual Duration (Months)
38.7
Patients Per Site
16.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    116 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
    Actual Study Start Date :
    Jun 11, 2019
    Actual Primary Completion Date :
    Aug 22, 2019
    Actual Study Completion Date :
    Aug 22, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kapit Hospital Kapit Sarawak Malaysia 96800
    2 Sarikei Hospital Sarikei Sarawak Malaysia 96100
    3 Sibu Hospital Sibu Sarawak Malaysia 96000

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Gregory C. Gray, MD, Duke University Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03988296
    Other Study ID Numbers:
    • Pro00102072
    First Posted:
    Jun 17, 2019
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duke University
    Monkey malaria
    Additional relevant MeSH terms:
    Malaria

    Study Results

    No Results Posted as of Oct 2, 2019