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

Menzies School of Health Research

Status: Withdrawn

Conditions: Malaria

Study type: Observational

Funder types: Other

Identifiers

NCT02793414

VOCE

Details and patient eligibility

About

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.

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 2 patient groups

Malaria patients

Febrile controls