Clinical trial NCT03920735: Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
Official title: Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Disease
Neoplams
Transplantation
Immunologic Deficiency Syndromes
Critical Illness
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in any department of the University Hospital of Strasbourg since 1997 Opportunistic infectious disease occurrence in immunocompromised or frail patients.

In case of epidemiological study, patients from a control group with the same characteristics but without infection can be included.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Short- and long-term survival, overall and in specific subgroups of patients
timeFrame: Long-term time point : 1st may 2019
measure: Short- and long-term survival, overall and in specific subgroups of patients
timeFrame: Short term : 1 month
measure: Short- and long-term survival, overall and in specific subgroups of patients
timeFrame: Short term : 3 months
measure: Short- and long-term survival, overall and in specific subgroups of patients
timeFrame: Short term : 6 months
Secondary outcomes:
measure: Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use
timeFrame: first day of opportunistic infection
measure: Prognosis factors in patients with opportunistic infection affecting the response to antimicrobial therapy (using response criteria defined by EORTC/MSG)
timeFrame: first day of opportunistic infection
measure: Identification of baseline prognosis factors affecting the 3 months survival
timeFrame: first day of opportunistic infection
measure: Identification of baseline prognosis factors affecting the 6 months survival
timeFrame: first day of opportunistic infection
measure: Incidence of specific opportunistic infections in different host groups
timeFrame: evolution of a 20-year-period
measure: Description of imaging patterns opportunistic infections: analysis of chest CT-scan and cerebral CT-scan and MRI by radiologists
timeFrame: at first day of infection and up to 12 weeks
measure: Assessment of performance of Aspergillus galactomannan detection test in serum
timeFrame: at onset and up to 1 week
measure: Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage
timeFrame: at onset and up to 1 week
measure: Response rate
timeFrame: at 1, 3 and 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Raoul HERBRECHT, MD
role: PRINCIPAL_INVESTIGATOR
References: