Acute Undifferentiated Fever in Ethiopia

Completed

• Conditions: Acute Febrile Illness

• Registration Number: NCT04268732
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-08-31
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Completion: 2020-12-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients presenting with acute fever (an axillary temperature of ≥37.5°C; symptom duration ≤7 days)
• ≥ 15 years old
• signed informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers	within 7 days after onset of fever	CRP (bacterial biomarker) and MxA (viral biomarker) will be evaluated for differentiating confirmed bacterial and viral infections.

Secondary Outcome Measures

Name	Time	Method
The number of malaria cases, bacterial infections, viral infections and unknown etiologies among acute febrile patients in Gondar	within 7 days after onset of fever	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.
The comparison of different assays for diagnosis of DENV	within 7 days after onset of fever	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.
The comparison of the qualitative and qualitative detection of CRP for differentiating bacterial and viral infections	within 7 days after onset of fever	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.

Trial Locations

Locations (2)

Institute of Tropical Medicine; 🇧🇪 Antwerp, Belgium

University of Gondar; 🇪🇹 Gondar, Ethiopia