NCT04301752

Brief Summary

Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries. Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 6, 2020

Last Update Submit

March 16, 2020

Conditions

Brucellosis

Keywords

Brucellosis, neuropsychiatric manifestations, cognition

Outcome Measures

Primary Outcomes (1)

  • MoCA s

    Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were \<26 .

    24 hours

Study Arms (2)

Neurobrucellosis

Brucellosis associated with neuropsychiatric manifestations

Diagnostic Test: MoCA

Non-neurobrucellosis

Brucellosis not associated with neuropsychiatric manifestations

Diagnostic Test: MoCA

Interventions

MoCADIAGNOSTIC_TEST

Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were \<26. Maximum score is 30.

NeurobrucellosisNon-neurobrucellosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

82 consecutive patients with brucellosis (18 patients with neuropsychiatric manifestations and 64 patients without neuropsychiatric manifestations) were recruited.

You may qualify if:

  • Patients \>18 years of age with laboratory-confirmed brucellosis

You may not qualify if:

  • Previous neuropsychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

Related Publications (4)

  • Young EJ. Brucella species. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 7th ed. Philadelphia: Churchill Livingstone, 2010:2921-5.

    RESULT

  • Pappas G, Akritidis N, Bosilkovski M, Tsianos E. Brucellosis. N Engl J Med. 2005 Jun 2;352(22):2325-36. doi: 10.1056/NEJMra050570. No abstract available.

    PMID: 15930423RESULT

  • Finn TB. Brucellosis. In: Cohen J, Powderly WG, eds. Infectious diseases. 2nd ed. New York: Elsevier, 2004:1665-9.

    RESULT

  • Eren S, Bayam G, Ergonul O, Celikbas A, Pazvantoglu O, Baykam N, Dokuzoguz B, Dilbaz N. Cognitive and emotional changes in neurobrucellosis. J Infect. 2006 Sep;53(3):184-9. doi: 10.1016/j.jinf.2005.10.029. Epub 2006 May 2.

    PMID: 16647757RESULT

MeSH Terms

Conditions

Brucellosis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)