Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics

NCT ID: NCT03047642

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2019-11-27

Brief Summary

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.

Conditions

Acute Febrile Illnesses

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Malawi febrile patients

Children and adults with fever presenting at the outpatient department

Biomarker assay

Intervention Type: 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

Brazil febrile patients

Children and adults with fever presenting at the outpatient department

Biomarker assay

Intervention Type: 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

Gabon febrile patients

Children with fever or with a recent history of fever presenting at the outpatient department

Biomarker assay

Intervention Type: 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

Interventions

Biomarker assay

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Children 2-17 years of age
• Adults 18-65 years of age
• Signed written informed consent for study participation. For recruitment purposes, subjects will be classified into two groups, children and adults. For children, age >2 years is the minimum cut-off, based on the amount of blood volume to be obtained in the study. WHO guidelines for allowable blood volume in 24 hours recommend that no more than 1-5% of total blood volume (75-80 ml/kg for older children) be obtained. Applying the average weight of a 2 year old toddler =12 kg, the allowable blood volume to be drawn in 24 hours at 1-5% of the total blood volume is 9.6 - 48 mL .

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

• Subjects who are felt to be in critical condition (based on clinician assessment or the presence of any general signs of critical illness as defined by WHO guidelines (for children: extensive vomiting, active seizure or recent history of seizures, altered mentation, inability to feed, or any of the severe IMNCI classifications; for adults: impending airway obstruction, central cyanosis, severe respiratory distress, feeble pulse, active seizure or recent history of seizures, or unconsciousness) because the target population for the study is non-severe febrile subjects.
• Subjects can only be enrolled once into the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Malawi Epidemiology and Intervention Research Unit

OTHER

Sponsor Role: collaborator

Instituto Nacional de Infectologia Evandro Chagas

UNKNOWN

Sponsor Role: collaborator

Centre de Recherche Médicale de Lambaréné

OTHER

Sponsor Role: collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Nacional de Infectologia Evandro Chagas - Fiocruz (INIEC)

Rio de Janeiro, , Brazil

CERMEL

Lambaréné, , Gabon

Karonga Prevention Study

Chilumba, Karonga District, Malawi

Countries

Brazil; Gabon; Malawi

References

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.

Reference Type: DERIVED

PMID: 39947818 (View on PubMed)

Other Identifiers

AFI_01

Identifier Type: -

Identifier Source: org_study_id