Clinical Trials Directory

Trials / Completed

CompletedNCT04268732

Acute Undifferentiated Fever in Ethiopia

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
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
Institute of Tropical Medicine, Belgium · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-06-01
Primary completion
2019-08-31
Completion
2020-12-30
First posted
2020-02-13
Last updated
2021-05-11

Locations

2 sites across 2 countries: Belgium, Ethiopia

Source: ClinicalTrials.gov record NCT04268732. Inclusion in this directory is not an endorsement.