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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malaria patients | |||
| Febrile controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance of the VOC breathalyser | Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of malaria parasite density with VOC concentrations | 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. | 7 days |
| G6PD variants |
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Malaria cohort
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Any participant above the age of 5 years fulfilling the inclusion criteria and attending the study hospital is eligible to participate in the study.
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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G6PD variants within the local population |
| 1 day |
| G6PD activity in U/gHb | The distribution of G6PD enzyme activity in the local population measured in U/gHb. | 1 day |
| Performance characteristics of qualitative and quantitative G6PD test formats. | Sensitivity and specificity of other G6PD diagnostic assays compared to the gold standard spectrophotometry | 1 day |
| D000079426 |
| Vector Borne Diseases |