Critical Illness Clinical Trial
Official title:
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
NCT number | NCT03920735 |
Other study ID # | 1INFOPP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2017 |
Est. completion date | July 15, 2019 |
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
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | July 15, 2019 |
Est. primary completion date | July 15, 2019 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Strasbourg, france | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
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 |
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