Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Menzies School of Health Research
- Primary Endpoint
- Performance of the VOC breathalyser
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Performance of the VOC breathalyser
Time Frame: 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 Outcomes
- G6PD activity in U/gHb(1 day)
- Correlation of malaria parasite density with VOC concentrations(7 days)
- G6PD variants(1 day)
- Performance characteristics of qualitative and quantitative G6PD test formats.(1 day)