Acute Febrile IllnessesNCT03047642
Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics
An observational study of Acute Febrile Illnesses, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Acute Febrile Illnesses
- What is being tested?
- Biomarker assay
- How many people
- 2,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 27 Apr 2017to 27 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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: * Children 2-17 years of age * Adults 18-65 years of age
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Instituto Nacional de Infectologia Evandro Chagas - Fiocruz (INIEC)
Rio de Janeiro
About this study
Official title: Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics in Africa and Latin America
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
- Being tested
- Biomarker assay
- Keywords
- biomarker, low and middle income countries, fever, antimicrobial resistance, diagnostic
- Medical subject headings
- Fever, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker assayDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Malawi febrile patients | Children and adults with fever presenting at the outpatient department Receives: Diagnostic Test: Biomarker assay | |
| Brazil febrile patients | Children and adults with fever presenting at the outpatient department Receives: Diagnostic Test: Biomarker assay | |
| Gabon febrile patients | Children with fever or with a recent history of fever presenting at the outpatient department Receives: Diagnostic Test: Biomarker assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start27 Apr 2017
- Primary completion27 Oct 2018
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Febrile IllnessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Malawi Epidemiology and Intervention Research Unit, Instituto Nacional de Infectologia Evandro Chagas, Centre de Recherche Médicale de Lambaréné
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047642
- Sponsor's protocol ID
- AFI_01
- Status last verified
- Feb 2021
- First submitted
- 10 Oct 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: As appropriate data will be made available to the scientific community and/or commercial partners to support product development activities.
Publications
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.
PubMed 39947818
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics in Africa and Latin America
- ClinicalTrials.gov ID
- NCT03047642
- Acronym / sponsor ID
- AFI_01
- Conditions
- Acute Febrile Illnesses
- Keywords
- biomarker, low and middle income countries, fever, antimicrobial resistance, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Malawi Epidemiology and Intervention Research Unit, Instituto Nacional de Infectologia Evandro Chagas, Centre de Recherche Médicale de Lambaréné
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malawi febrile patients | – | Diagnostic Test: Biomarker assayChildren and adults with fever presenting at the outpatient department |
| Brazil febrile patients | – | Diagnostic Test: Biomarker assayChildren and adults with fever presenting at the outpatient department |
| Gabon febrile patients | – | Diagnostic Test: Biomarker assayChildren with fever or with a recent history of fever presenting at the outpatient department |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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: * Children 2-17 years of age * Adults 18-65 years of age
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker assayThere 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 | Diagnostic test | Brazil febrile patients, Gabon febrile patients, Malawi febrile patients |
Primary outcome
Diagnostic sensitivity and specificity to determine bacterial infections compared to clinical and microbiological results aggregated in a study database.
Time frame: 1year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 39947818Fernandez-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.
- Individual participant dataSharing planned: Yes. As appropriate data will be made available to the scientific community and/or commercial partners to support product development activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Febrile Illnesses, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Gabon, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity and specificity to determine bacterial infections compared to clinical and microbiological results aggregated in a study database. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.