Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
- Conditions
- Malaria
- Registration Number
- NCT02793414
- Lead Sponsor
- Menzies School of Health Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method G6PD activity in U/gHb 1 day The distribution of G6PD enzyme activity in the local population measured in U/gHb.
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
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