InfectionsNCT05919550
Clozapine-associated Infection
An observational study of Infections, run by University Hospital, Caen at 1 site in France.
Trial summary
perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections
- What is being tested?
- search for a clozapine intake
- How many people
- 26,815,616 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2023to 11 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a possible drug-induced adverse effect
Who may be able to join
- Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023
- Adverse events reported were including the MedDRA terms: infections (SOC)
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14033
About this study
perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.
- Conditions
- Infections
- Being tested
- search for a clozapine intake
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
search for a clozapine intakeDrug
search for a clozapine intake
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting a possible drug-induced adverse effects | Not described Receives: Drug: search for a clozapine intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®
Measured: from the 01/01/1963 to the 11/04/2023
Secondary outcomes (2)
investigate a potential dose-dependent effect
A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses.
Measured: from the 01/01/1963 to the 11/04/2023
Description of the clinical features of clozapine-related infections
Description of age, sex, time to onset, type of infections using MedDRA
Measured: from the 01/01/1963 to the 11/04/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start11 Apr 2023
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 26,815,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919550
- Sponsor's protocol ID
- Clozinfection
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine-associated Infection
- ClinicalTrials.gov ID
- NCT05919550
- Acronym / sponsor ID
- Clozinfection
- Conditions
- Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,815,616 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 26 Jun 2023 (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.
perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting a possible drug-induced adverse effects | – | Drug: search for a clozapine intake |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a possible drug-induced adverse effect
Key inclusion criteria (2 listed)
- Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023
- Adverse events reported were including the MedDRA terms: infections (SOC)
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
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 |
|---|---|---|
| search for a clozapine intakesearch for a clozapine intake | Drug | Patients presenting a possible drug-induced adverse effects |
Primary outcome
Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®
Time frame: from the 01/01/1963 to the 11/04/2023
2 secondary outcomes
investigate a potential dose-dependent effect
Time frame: from the 01/01/1963 to the 11/04/2023
Description of the clinical features of clozapine-related infections
Time frame: from the 01/01/1963 to the 11/04/2023
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 26 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Infections
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 3
Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
Neurosyphilis
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infections, run by University Hospital, Caen at 1 site in France.
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 2 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 26 Jun 2023. 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 France. 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?
Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase® (time frame: from the 01/01/1963 to the 11/04/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2023.