Acute Undifferentiated Fever in Ethiopia

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Acute Febrile Illness

Study type: Observational

Funder types: Other

Identifiers

NCT04268732

1284/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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