Acute Undifferentiated Fever in Ethiopia

NCT04268732 | Completed

• 1 other identifier: 1284/19
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

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.

Conditions

Acute Febrile Illness

Keywords

biomarkers; bacterial infection; viral infection; malarial infection

Outcome Measures

Primary Outcomes (1)

• The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers

  CRP (bacterial biomarker) and MxA (viral biomarker) will be evaluated for differentiating confirmed bacterial and viral infections.

  within 7 days after onset of fever

Secondary Outcomes (3)

• 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

• The comparison of different assays for diagnosis of DENV

  within 7 days after onset of fever

• The comparison of the qualitative and qualitative detection of CRP for differentiating bacterial and viral infections

  within 7 days after onset of fever

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients ≥ 15 years old with acute undifferentiated fever and seeking health services within 7 days after fever onset at the emergency ward of the university of Gondar hospital (Ethiopia) during the study period.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Gondar: collaborator

Study Sites (2)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

University of Gondar

Gonder, Ethiopia

Location

Related Publications (7)

• Bhargava A, Ralph R, Chatterjee B, Bottieau E. Assessment and initial management of acute undifferentiated fever in tropical and subtropical regions. BMJ. 2018 Nov 29;363:k4766. doi: 10.1136/bmj.k4766. No abstract available.

  PMID: 30498133 BACKGROUND

• Mohammed Yusuf A, Abdurashid Ibrahim N. Knowledge, attitude and practice towards dengue fever prevention and associated factors among public health sector health-care professionals: in Dire Dawa, eastern Ethiopia. Risk Manag Healthc Policy. 2019 Jun 7;12:91-104. doi: 10.2147/RMHP.S195214. eCollection 2019.

  PMID: 31239796 BACKGROUND

• Ferede G, Tiruneh M, Abate E, Wondimeneh Y, Damtie D, Gadisa E, Howe R, Aseffa A, Tessema B. A serologic study of dengue in northwest Ethiopia: Suggesting preventive and control measures. PLoS Negl Trop Dis. 2018 May 31;12(5):e0006430. doi: 10.1371/journal.pntd.0006430. eCollection 2018 May.

  PMID: 29852020 BACKGROUND

• Lilay A, Asamene N, Bekele A, Mengesha M, Wendabeku M, Tareke I, Girmay A, Wuletaw Y, Adossa A, Ba Y, Sall A, Jima D, Mengesha D. Reemergence of yellow fever in Ethiopia after 50 years, 2013: epidemiological and entomological investigations. BMC Infect Dis. 2017 May 15;17(1):343. doi: 10.1186/s12879-017-2435-4.

  PMID: 28506254 BACKGROUND

• Animut A, Mekonnen Y, Shimelis D, Ephraim E. Febrile illnesses of different etiology among outpatients in four health centers in Northwestern Ethiopia. Jpn J Infect Dis. 2009 Mar;62(2):107-10.

  PMID: 19305049 BACKGROUND

• Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.

  PMID: 27486746 BACKGROUND

• Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Shapiro NI. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J Clin Med. 2017 Oct 7;6(10):94. doi: 10.3390/jcm6100094.

  PMID: 28991170 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood serum blood culture bottles

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Johan van Griensven, PhD, MD

  Institute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: June 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: December 30, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

ET (1); BE (1)