Acute Febrile IllnessNCT04268732
Acute Undifferentiated Fever in Ethiopia
An observational study of Acute Febrile Illness, run by Institute of Tropical Medicine, Belgium at 2 sites in 2 countries.
Trial summary
A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Febrile Illness
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2019to 30 Dec 2020
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients ≥ 15 years old with acute undifferentiated fever and seeking health services within 7 days after fever onset at the emergency ward of the university of Gondar hospital (Ethiopia) during the study period.
Who may be able to join
- Patients presenting with acute fever (an axillary temperature of ≥37.5°C; symptom duration ≤7 days)
- ≥ 15 years old
- signed informed consent
Who cannot join
- pregnant woman \& children (<15 y)
- febrile patient suspected of urinary tract infection or acute respiratory tract infection
- Individuals who had taken antimicrobial and antimalarial drug in the last 2 weeks
- Patients with acute injury or trauma or for which participation in the study implies an unacceptable health risk as determined by the physicians
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Causes of Acute Undifferentiated Fever and the Utility of Biomarkers in Differentiating Bacterial From Viral Infection Among Acute Febrile Patients in Northwest Ethiopia
A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia.
Read the detailed description
General objective:
To assess the causes of acute undifferentiated febrile illness and evaluation of biomarkers for differentiation of bacterial and viral infections among outpatients at University of Gondar (UOG) Hospital, Northwest Ethiopia
Specific objectives
- To determine the number of malaria cases, bacterial infections (by blood culture and polymearase chain reaction (PCR) for Rickettsia and Borrelia), and arboviral infections (DENV, YFV, CHIKV) among all acute febrile patients
- To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
- To evaluate the qualitative detection of C-reactive protein (CRP) and Myxovirus resistance protein (MxA) (by FebriDx RDT) and quantitative CRP detection for differentiating bacterial and viral infections
Study design, population, materials and methods: a cross-sectional cohort study on febrile patients presenting with acute fever at the emergency ward of the UOG hospital from June to August 2019. Clinical and epidemiological data will be recorded in a pseudo-anonymized and collected using an electronic data collection tool (KoBoToolbox). Blood will be collected for RDT testing, blood culture, PCR and serum for ELISA and RT-PCR.
Sample size: 200 acute febrile patients
Expected results and relevance: Evaluation of the causes of acute febrile illness and the role of biomarkers in differentiating viral and bacterial infections will increase the awareness of circulating pathogens and improve patient management. This evidence will contribute to a more rational use of laboratory diagnostic tests, antibiotics and antimalarial treatment.
- Conditions
- Acute Febrile Illness
- Keywords
- biomarkers, bacterial infection, viral infection, malarial infection
- Medical subject headings
- Bacterial Infections, Virus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers
CRP (bacterial biomarker) and MxA (viral biomarker) will be evaluated for differentiating confirmed bacterial and viral infections.
Measured: within 7 days after onset of fever
Secondary outcomes (3)
The number of malaria cases, bacterial infections, viral infections and unknown etiologies among acute febrile patients in Gondar
Different diagnostic tools will be used for analysis of acute febrile patient samples to confirm malaria (by RDT), bacterial infection (by blood culture and PCR for Rickettsia and Borrelia) and for viral infections (by RT-PCR for DENV, CHIKV, YFV). Samples negative for all these tests are defined as unknown etiology.
Measured: within 7 days after onset of fever
The comparison of different assays for diagnosis of DENV
Different diagnostic tests will be evaluated for the detection of acute DENV infection (NS1 RDT, RT-PCR, ELISA IgM) and past DENV infection (ELISA IgG) among acute febrile patients.
Measured: within 7 days after onset of fever
The comparison of the qualitative and qualitative detection of CRP for differentiating bacterial and viral infections
Qualitative CRP levels will be measured by FebriDx test and quantitative CRP levels will be measured by QuikReadGo. The detection of > 20mg/L CRP will be used to evaluate the confirmed bacterial infections and to compare with antibiotic treatment.
Measured: within 7 days after onset of fever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jun 2019
- Primary completion31 Aug 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Febrile IllnessStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar
- Responsible party
- Sponsor
- Investigators
- Johan van Griensven, PhD, MD, Study director, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268732
- Sponsor's protocol ID
- 1284/19
- Status last verified
- May 2021
- First submitted
- 11 Feb 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhargava A, Ralph R, Chatterjee B, Bottieau E. Assessment and initial management of acute undifferentiated fever in tropical and subtropical regions. BMJ. 2018 Nov 29;363:k4766. doi: 10.1136/bmj.k4766. No abstract available.
PubMed 30498133Mohammed Yusuf A, Abdurashid Ibrahim N. Knowledge, attitude and practice towards dengue fever prevention and associated factors among public health sector health-care professionals: in Dire Dawa, eastern Ethiopia. Risk Manag Healthc Policy. 2019 Jun 7;12:91-104. doi: 10.2147/RMHP.S195214. eCollection 2019.
PubMed 31239796Ferede G, Tiruneh M, Abate E, Wondimeneh Y, Damtie D, Gadisa E, Howe R, Aseffa A, Tessema B. A serologic study of dengue in northwest Ethiopia: Suggesting preventive and control measures. PLoS Negl Trop Dis. 2018 May 31;12(5):e0006430. doi: 10.1371/journal.pntd.0006430. eCollection 2018 May.
PubMed 29852020Lilay A, Asamene N, Bekele A, Mengesha M, Wendabeku M, Tareke I, Girmay A, Wuletaw Y, Adossa A, Ba Y, Sall A, Jima D, Mengesha D. Reemergence of yellow fever in Ethiopia after 50 years, 2013: epidemiological and entomological investigations. BMC Infect Dis. 2017 May 15;17(1):343. doi: 10.1186/s12879-017-2435-4.
PubMed 28506254Animut A, Mekonnen Y, Shimelis D, Ephraim E. Febrile illnesses of different etiology among outpatients in four health centers in Northwestern Ethiopia. Jpn J Infect Dis. 2009 Mar;62(2):107-10.
PubMed 19305049Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.
PubMed 27486746Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Shapiro NI. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J Clin Med. 2017 Oct 7;6(10):94. doi: 10.3390/jcm6100094.
PubMed 28991170
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Acute Undifferentiated Fever and the Utility of Biomarkers in Differentiating Bacterial From Viral Infection Among Acute Febrile Patients in Northwest Ethiopia
- ClinicalTrials.gov ID
- NCT04268732
- Acronym / sponsor ID
- 1284/19
- Conditions
- Acute Febrile Illness
- Keywords
- biomarkers, bacterial infection, viral infection, malarial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia.
Detailed description
General objective:
To assess the causes of acute undifferentiated febrile illness and evaluation of biomarkers for differentiation of bacterial and viral infections among outpatients at University of Gondar (UOG) Hospital, Northwest Ethiopia
Specific objectives
- To determine the number of malaria cases, bacterial infections (by blood culture and polymearase chain reaction (PCR) for Rickettsia and Borrelia), and arboviral infections (DENV, YFV, CHIKV) among all acute febrile patients
- To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
- To evaluate the qualitative detection of C-reactive protein (CRP) and Myxovirus resistance protein (MxA) (by FebriDx RDT) and quantitative CRP detection for differentiating bacterial and viral infections
Study design, population, materials and methods: a cross-sectional cohort study on febrile patients presenting with acute fever at the emergency ward of the UOG hospital from June to August 2019. Clinical and epidemiological data will be recorded in a pseudo-anonymized and collected using an electronic data collection tool (KoBoToolbox). Blood will be collected for RDT testing, blood culture, PCR and serum for ELISA and RT-PCR.
Sample size: 200 acute febrile patients
Expected results and relevance: Evaluation of the causes of acute febrile illness and the role of biomarkers in differentiating viral and bacterial infections will increase the awareness of circulating pathogens and improve patient management. This evidence will contribute to a more rational use of laboratory diagnostic tests, antibiotics and antimalarial treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients ≥ 15 years old with acute undifferentiated fever and seeking health services within 7 days after fever onset at the emergency ward of the university of Gondar hospital (Ethiopia) during the study period.
Key inclusion criteria (3 listed)
- Patients presenting with acute fever (an axillary temperature of ≥37.5°C; symptom duration ≤7 days)
- ≥ 15 years old
- signed informed consent
Key exclusion criteria (4 listed)
- pregnant woman \& children (<15 y)
- febrile patient suspected of urinary tract infection or acute respiratory tract infection
- Individuals who had taken antimicrobial and antimalarial drug in the last 2 weeks
- Patients with acute injury or trauma or for which participation in the study implies an unacceptable health risk as determined by the physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers
Time frame: within 7 days after onset of fever
CRP (bacterial biomarker) and MxA (viral biomarker) will be evaluated for differentiating confirmed bacterial and viral infections.
3 secondary outcomes
The number of malaria cases, bacterial infections, viral infections and unknown etiologies among acute febrile patients in Gondar
Time frame: within 7 days after onset of fever
The comparison of different assays for diagnosis of DENV
Time frame: within 7 days after onset of fever
The comparison of the qualitative and qualitative detection of CRP for differentiating bacterial and viral infections
Time frame: within 7 days after onset of fever
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 11 May 2021.
- Background: PubMed 30498133Bhargava A, Ralph R, Chatterjee B, Bottieau E. Assessment and initial management of acute undifferentiated fever in tropical and subtropical regions. BMJ. 2018 Nov 29;363:k4766. doi: 10.1136/bmj.k4766. No abstract available.
- Background: PubMed 31239796Mohammed Yusuf A, Abdurashid Ibrahim N. Knowledge, attitude and practice towards dengue fever prevention and associated factors among public health sector health-care professionals: in Dire Dawa, eastern Ethiopia. Risk Manag Healthc Policy. 2019 Jun 7;12:91-104. doi: 10.2147/RMHP.S195214. eCollection 2019.
- Background: PubMed 29852020Ferede G, Tiruneh M, Abate E, Wondimeneh Y, Damtie D, Gadisa E, Howe R, Aseffa A, Tessema B. A serologic study of dengue in northwest Ethiopia: Suggesting preventive and control measures. PLoS Negl Trop Dis. 2018 May 31;12(5):e0006430. doi: 10.1371/journal.pntd.0006430. eCollection 2018 May.
- Background: PubMed 28506254Lilay A, Asamene N, Bekele A, Mengesha M, Wendabeku M, Tareke I, Girmay A, Wuletaw Y, Adossa A, Ba Y, Sall A, Jima D, Mengesha D. Reemergence of yellow fever in Ethiopia after 50 years, 2013: epidemiological and entomological investigations. BMC Infect Dis. 2017 May 15;17(1):343. doi: 10.1186/s12879-017-2435-4.
- Background: PubMed 19305049Animut A, Mekonnen Y, Shimelis D, Ephraim E. Febrile illnesses of different etiology among outpatients in four health centers in Northwestern Ethiopia. Jpn J Infect Dis. 2009 Mar;62(2):107-10.
- Background: PubMed 27486746Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.
- Background: PubMed 28991170Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Shapiro NI. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J Clin Med. 2017 Oct 7;6(10):94. doi: 10.3390/jcm6100094.
- Individual participant dataSharing planned: Undecided
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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.
Johan van Griensven, PhD, MD study director
Institute of Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Febrile Illness, run by Institute of Tropical Medicine, Belgium at 2 sites in 2 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 3 inclusion and 4 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Ethiopia. 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?
The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers (time frame: within 7 days after onset of fever). 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 NCT04268732, which also lists 7 linked publications.
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 11 May 2021.