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

NCT ID: NCT02793414

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Malaria patients

No interventions assigned to this group

Febrile controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menzies School of Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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VOCE

Identifier Type: -

Identifier Source: org_study_id

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