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Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia

Sponsor
Menzies School of Health Research (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02793414
Collaborator
(none)
0
Enrollment
16
Duration (Months)

Study Details

Study Description

Brief Summary

This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.

Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2016
    Anticipated Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Jan 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Malaria patients
    Febrile controls

    Outcome Measures

    Primary Outcome Measures

    1. Performance of the VOC breathalyser [7 days]

      Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria.

    Secondary Outcome Measures

    1. Correlation of malaria parasite density with VOC concentrations [7 days]

      The correlation of malaria parasite density with VOC concentrations in patients with clinical and subpatent malaria and the recovery profile of VOC following acute malaria.

    2. G6PD variants [1 day]

      G6PD variants within the local population

    3. G6PD activity in U/gHb [1 day]

      The distribution of G6PD enzyme activity in the local population measured in U/gHb.

    4. Performance characteristics of qualitative and quantitative G6PD test formats. [1 day]

      Sensitivity and specificity of other G6PD diagnostic assays compared to the gold standard spectrophotometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Malaria cohort

    • Age ≥5 years of age

    • Malaria microscopy and / or Malaria RDT confirmed malaria infection

    • Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours

    • Written informed consent Febrile controls

    • Age ≥5 years of age

    • Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours

    • Absence of a malaria episode confirmed by malaria microscopy

    • Written informed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Menzies School of Health Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Menzies School of Health Research
    ClinicalTrials.gov Identifier:
    NCT02793414
    Other Study ID Numbers:
    • VOCE
    First Posted:
    Jun 8, 2016
    Last Update Posted:
    Oct 6, 2020
    Last Verified:
    Oct 1, 2020
    Additional relevant MeSH terms:
    Malaria

    Study Results

    No Results Posted as of Oct 6, 2020