Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT04268732
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Undifferentiated Fever in Ethiopia
Sponsor:
Institute of Tropical Medicine, Belgium
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
1. 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
2. To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
3. 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.
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
1. 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
2. To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: