Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients

Critical Illness Clinical Trial

Official title:

Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920735
• Other study ID #: 1INFOPP
• Status: Recruiting
• Start date: March 15, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: September 2018
• Source: University Hospital, Strasbourg, France
• Contact: Raoul HERBRECHT, MD
• Phone: 03 88 12 83 79
• Email: raoul.herbrecht[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management.

The primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Non selected consecutive immunocompromised or frail patients with an opportunistic infection

• Hospitalized in any of the department of the University Hospital of Strasbourg

• For epidemiological study, patients with similar immunodepression of frail condition and no opportunistic infection

Exclusion criteria:

• Opposition of the patient to use his personal data

Related Conditions & MeSH terms

• Critical Illness
• Hematologic Disease
• Hematologic Diseases
• Immunologic Deficiency Syndromes
• Neoplams
• Opportunistic Infections
• Transplantation

Locations

Country	Name	City	State
France	University Hospital, Strasbourg, france	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short- and long-term survival, overall and in specific subgroups of patients		Long-term time point : 1st may 2019
Primary	Short- and long-term survival, overall and in specific subgroups of patients		Short term : 1 month
Primary	Short- and long-term survival, overall and in specific subgroups of patients		Short term : 3 months
Primary	Short- and long-term survival, overall and in specific subgroups of patients		Short term : 6 months
Secondary	Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use		first day of opportunistic infection
Secondary	Prognosis factors in patients with opportunistic infection affecting the response to antimicrobial therapy (using response criteria defined by EORTC/MSG)		first day of opportunistic infection
Secondary	Identification of baseline prognosis factors affecting the 3 months survival		first day of opportunistic infection
Secondary	Identification of baseline prognosis factors affecting the 6 months survival		first day of opportunistic infection
Secondary	Incidence of specific opportunistic infections in different host groups		evolution of a 20-year-period
Secondary	Description of imaging patterns opportunistic infections: analysis of chest CT-scan and cerebral CT-scan and MRI by radiologists		at first day of infection and up to 12 weeks
Secondary	Assessment of performance of Aspergillus galactomannan detection test in serum		at onset and up to 1 week
Secondary	Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage		at onset and up to 1 week
Secondary	Response rate		at 1, 3 and 6 months