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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02793414

Enrollment

Registered

2016-06-08

Start date

2016-09-30

Completion date

2018-01-31

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
G6PD variants	1 day	G6PD variants within the local population
G6PD activity in U/gHb	1 day	The distribution of G6PD enzyme activity in the local population measured in U/gHb.
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

Outcome results