BrucellosisNCT04301752
Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis
An observational study of Brucellosis, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brucellosis
- What is being tested?
- MoCA
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 82 consecutive patients with brucellosis (18 patients with neuropsychiatric manifestations and 64 patients without neuropsychiatric manifestations) were recruited.
Who may be able to join
- Patients >18 years of age with laboratory-confirmed brucellosis
Who cannot join
- Previous neuropsychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features
- Conditions
- Brucellosis
- Being tested
- MoCA
- Keywords
- Brucellosis, neuropsychiatric manifestations, cognition
- Medical subject headings
- Brucellosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCADiagnostic test
Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.
| Study group | Role | What they receive |
|---|---|---|
| Neurobrucellosis | Brucellosis associated with neuropsychiatric manifestations Receives: Diagnostic Test: MoCA | |
| Non-neurobrucellosis | Brucellosis not associated with neuropsychiatric manifestations Receives: Diagnostic Test: MoCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA s
Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 .
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BrucellosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301752
- Sponsor's protocol ID
- Mansoura University 13
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 15930423Finn TB. Brucellosis. In: Cohen J, Powderly WG, eds. Infectious diseases. 2nd ed. New York: Elsevier, 2004:1665-9.
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.
PubMed 16647757
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis
- ClinicalTrials.gov ID
- NCT04301752
- Acronym / sponsor ID
- Mansoura University 13
- Conditions
- Brucellosis
- Keywords
- Brucellosis, neuropsychiatric manifestations, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurobrucellosis | – | Diagnostic Test: MoCABrucellosis associated with neuropsychiatric manifestations |
| Non-neurobrucellosis | – | Diagnostic Test: MoCABrucellosis not associated with neuropsychiatric manifestations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 82 consecutive patients with brucellosis (18 patients with neuropsychiatric manifestations and 64 patients without neuropsychiatric manifestations) were recruited.
Key inclusion criteria (1 listed)
- Patients >18 years of age with laboratory-confirmed brucellosis
Key exclusion criteria (1 listed)
- Previous neuropsychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoCACognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30. | Diagnostic test | Neurobrucellosis, Non-neurobrucellosis |
Primary outcome
MoCA s
Time frame: 24 hours
Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Results publicationYoung 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.
- Results publication: PubMed 15930423Pappas 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.
- Results publicationFinn TB. Brucellosis. In: Cohen J, Powderly WG, eds. Infectious diseases. 2nd ed. New York: Elsevier, 2004:1665-9.
- Results publication: PubMed 16647757Eren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brucellosis, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA s (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301752, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.