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| Name | Class |
|---|---|
| Malawi Epidemiology and Intervention Research Unit | OTHER |
| Instituto Nacional de Infectologia Evandro Chagas | UNKNOWN |
| Centre de Recherche Médicale de Lambaréné | OTHER |
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This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malawi febrile patients | Children and adults with fever presenting at the outpatient department |
| |
| Brazil febrile patients | Children and adults with fever presenting at the outpatient department |
| |
| Gabon febrile patients | Children with fever or with a recent history of fever presenting at the outpatient department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker assay | Diagnostic Test | There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic sensitivity and specificity to determine bacterial infections compared to clinical and microbiological results aggregated in a study database. | Microbiological testing (blood culture positive/negative, malaria pos/neg, S. Tyhpi RDT pos/neg) and clinical assessments of symptoms (respiratory, gastro, no foci) will be recorded and reviewed by a clinical panel upon completion of the study to assign a final category (bacterial or non-bacterial). These categories are used in the evaluation of the biomarker assays to evaluate their performance in differentiating bacterial from non-bacterial infections. Where applicable, the same categories will be used to determine the area under the curve by employing receiver operator characteristics (ROC) analysis of quantitative markers. | 1year |
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Inclusion Criteria:
Any non-severely ill subject presenting with acute fever defined as: temperature of more than 38°C at initial evaluation of less than 7 days of symptoms at presentation.
Inclusion criteria:
For minors, caregivers will provide informed consent. Documented assent for children of 12 to 16 years of age will be required for their participation.
Exclusion Criteria:
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Any non-severely ill subject presenting with acute fever defined as: temperature of more than 38°C at initial evaluation of less than 7 days of symptoms at presentation.
For recruitment purposes, subjects will be classified into two groups:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas - Fiocruz (INIEC) | Rio de Janeiro | Brazil | ||||
| CERMEL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39947818 | Derived | Fernandez-Carballo BL, Atzeni M, Escadafal C, Vettoretti M, Geis S, Agnandji ST, Siqueira AM, Malava JK, Banda L, Kabwende AL, Alabi A, Ondo JCB, Massinga-Loembe M, Essone PN, Moreira J, da Rocha Matos A, Caetano BC, Siqueira MM, Bispo de Filippis AM, Dos Santos Ribeiro da Silva EA, Lourenco MCS, Haring J, Gunther A, Jakobi M, Schneiderhan-Marra N, Hoogland C, Brasil P, Pokharel S, Ongarello S, Harris V, Mace A, Lee SJ, Di Camillo B, Dittrich S. Cross-sectional evaluation of host biomarkers for guiding antibiotic use in bacterial and non-bacterial acute febrile illness in low- and middle-income tropical settings. BMJ Open. 2025 Feb 13;15(2):e086912. doi: 10.1136/bmjopen-2024-086912. |
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As appropriate data will be made available to the scientific community and/or commercial partners to support product development activities.
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| ID | Term |
|---|---|
| D005334 | Fever |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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Samples of whole blood, plasma, serum and urine are stored to establish a biobank of characterized samples for further development and testing of diagnostic tools for differential diagnosis of multiple febrile diseases in endemic areas.
| Lambaréné |
| Gabon |
| Karonga Prevention Study | Chilumba | Karonga District | Malawi |