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Completed

NCT Number: NCT04268732

Acute Undifferentiated Fever in 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.

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Key information

Conditions

Acute Febrile Illness Bacterial Infections Bacterial Infections and Mycoses Infections Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Tropical Medicine, Antwerp, Belgium

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. The comparison of different assays for diagnosis of DENV

    Time frame: 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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • University of Gondar

Registry information

Official study title

Causes of Acute Undifferentiated Fever and the Utility of Biomarkers in Differentiating Bacterial From Viral Infection Among Acute Febrile Patients in Northwest Ethiopia

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 13, 2020
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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