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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03920735
Collaborator
(none)
1,000
1
28
35.7

Study Details

Study Description

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

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 15, 2017
Anticipated Primary Completion Date :
Jul 15, 2019
Anticipated Study Completion Date :
Jul 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Opportunistic infection

Immunocompromised or frail patients with an opportunistic infection

Control group

Immunocompromised or frail patients with no opportunistic infection

Outcome Measures

Primary Outcome Measures

  1. Short- and long-term survival, overall and in specific subgroups of patients [Long-term time point : 1st may 2019]

  2. Short- and long-term survival, overall and in specific subgroups of patients [Short term : 1 month]

  3. Short- and long-term survival, overall and in specific subgroups of patients [Short term : 3 months]

  4. Short- and long-term survival, overall and in specific subgroups of patients [Short term : 6 months]

Secondary Outcome Measures

  1. Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use [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) [first day of opportunistic infection]

  3. Identification of baseline prognosis factors affecting the 3 months survival [first day of opportunistic infection]

  4. Identification of baseline prognosis factors affecting the 6 months survival [first day of opportunistic infection]

  5. Incidence of specific opportunistic infections in different host groups [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 [at first day of infection and up to 12 weeks]

  7. Assessment of performance of Aspergillus galactomannan detection test in serum [at onset and up to 1 week]

  8. Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage [at onset and up to 1 week]

  9. Response rate [at 1, 3 and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 University Hospital, Strasbourg, france Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Raoul HERBRECHT, MD, University Hospital, Strasbourg, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03920735
Other Study ID Numbers:
  • 1INFOPP
First Posted:
Apr 19, 2019
Last Update Posted:
Apr 19, 2019
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2019