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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920735
Recruitment Status : Unknown
Verified September 2018 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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


Condition or disease
Hematologic Disease Neoplams Transplantation Immunologic Deficiency Syndromes Critical Illness

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 15, 2019
Groups and Cohorts
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Group/Cohort
Opportunistic infection
Immunocompromised or frail patients with an opportunistic infection
Control group
Immunocompromised or frail patients with no opportunistic infection


Outcome Measures
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Primary Outcome Measures :
  1. Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Long-term time point : 1st may 2019 ]
  2. Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 1 month ]
  3. Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 3 months ]
  4. Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 6 months ]

Secondary Outcome Measures :
  1. Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use [ Time Frame: first day of opportunistic infection ]
  2. Prognosis factors in patients with opportunistic infection affecting the response to antimicrobial therapy (using response criteria defined by EORTC/MSG) [ Time Frame: first day of opportunistic infection ]
  3. Identification of baseline prognosis factors affecting the 3 months survival [ Time Frame: first day of opportunistic infection ]
  4. Identification of baseline prognosis factors affecting the 6 months survival [ Time Frame: first day of opportunistic infection ]
  5. Incidence of specific opportunistic infections in different host groups [ Time Frame: evolution of a 20-year-period ]
  6. Description of imaging patterns opportunistic infections: analysis of chest CT-scan and cerebral CT-scan and MRI by radiologists [ Time Frame: at first day of infection and up to 12 weeks ]
  7. Assessment of performance of Aspergillus galactomannan detection test in serum [ Time Frame: at onset and up to 1 week ]
  8. Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage [ Time Frame: at onset and up to 1 week ]
  9. Response rate [ Time Frame: at 1, 3 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920735


Contacts
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Contact: Raoul HERBRECHT, MD 03 88 12 83 79 ext 0033 raoul.herbrecht@chru-strasbourg.fr

Locations
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France
University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67091
Contact: Raoul HERBRECHT, MD    03 88 12 83 79 ext 0033    raoul.herbrecht@chru-strasbourg.fr   
Principal Investigator: Raoul Raoul, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Raoul HERBRECHT, MD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03920735    
Other Study ID Numbers: 1INFOPP
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opportunistic Infections
Hematologic Diseases
Immunologic Deficiency Syndromes
Critical Illness
Infection
 Disease Attributes
Pathologic Processes
Virus Diseases
Parasitic Diseases
Immune System Diseases