Investigation of Fever Suspected as a Zoonosis Using Advanced Diagnostic Technologies

NCT04717622 | Unknown

• 1 other identifier: SOR-20-0287-CTIL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Zoonosis including brucellosis and rickettsial infections are a major contributor to infectious morbidity in southern Israel. The Bedouins, a nomadic tribal population residing in the Negev area are notably exposed to domesticated animals including livestock, camels and companion animals, and their living conditions, especially with respect to poor sanitation in different Bedouin communities also expose them to rodents and disease vectors such as insects and arthropods. In this study, we aim to identify Bedouin patients arriving at the Soroka University Medical Center, a tertiary hospital un the Negev, with undifferentiated fever, suspected as a zoonosis. We intend to use molecular methods to better diagnose the infectious agent using whole blood and serum samples, and when available other tissues or body fluid, and use next generation sequencing technology to deeply examine bacterial features such as virulence factors, and host pathogen interactions.

Conditions

Brucellosis; Zoonotic Disease

Outcome Measures

Primary Outcomes (4)

• Diagnosis of zoonotic infections

  Molecular modes of diagnosis will be examined, in order to improve sensitivity and time to diagnosis

  patients will be under follow up for 6 months after enrollment

• Clinical outcomes- relapse

  Assessment of infection relapse within 6 months

  patients will be under follow up for 6 months after enrollment

• Clinical outcomes- symptom resolution

  time to resolution of symptoms

  patients will be under follow up for 6 months after enrollment, medical records will be reviewed for a year after enrollment

• Clinical outcomes- antibiotic use

  recurrent use of antibiotics during the study period

  patients will be under follow up for 6 months after enrollment, medical records will be reviewed for a year after enrollment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients of Bedouin origin presenting with undifferentiated fever to the emergency departments (ED) at Soroka University Medical Center (SUMC) (adults) or hospitalized (internal medicine or pediatrics) between September 2020 until October 2023 will be screened and those who meet the inclusion criteria will be offered the opportunity to enroll in this study

You may qualify if:

• \- Willing and able to provide informed consent (in case of children the legal guardian is willing to provide informed consent)
• All patients of Bedouin origin arriving at the SUMC ED during the study period with:
• fever \>38.1 (either documented or reported), without an apparent infection source plus one of the following signs or symptoms
• Headache
• Rash
• Arthralgia, arthritis
• Weakness
• Myalgia
• epididymo-orchitis
• leukopenia, thrombocytopenia, elevated liver enzymes
• other findings suggestive of zoonotic infection
• Patients who were diagnosed with a zoonotic infection prior to or during hospital stay.

You may not qualify if:

• \- Patients with an established source of infection other than zoonosis (such as urinary tract infection, pneumonia, upper respiratory tract infection), or a non-infectious cause of fever (malignancy, rheumatic disease etc.).
• Pregnant women
• Children weighing less than 6.5 kg

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples will be kept without any processing or analysis of human DNA

MeSH Terms

Conditions

Brucellosis; Zoonoses

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Animal Diseases

Study Officials

• Yael Yagel, MD

  Senior doctor, infectious diseases

  STUDY DIRECTOR

Central Study Contacts

Yael Yagel, MD

CONTACT

972545385092; ygrushka@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor, infectious diseases institute Soroka UMC

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 22, 2021
• Study Start: May 23, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)