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

NCT03920735 | Unknown

• 1 other identifier: 1INFOPP
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Disease; Neoplams; Transplantation; Immunologic Deficiency Syndromes; Critical Illness

Outcome Measures

Primary Outcomes (4)

• Short- and long-term survival, overall and in specific subgroups of patients

  Long-term time point : 1st may 2019

• Short- and long-term survival, overall and in specific subgroups of patients

  Short term : 1 month

• Short- and long-term survival, overall and in specific subgroups of patients

  Short term : 3 months

• Short- and long-term survival, overall and in specific subgroups of patients

  Short term : 6 months

Secondary Outcomes (9)

• Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use

  first day of opportunistic infection

• 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

• Identification of baseline prognosis factors affecting the 3 months survival

  first day of opportunistic infection

• Identification of baseline prognosis factors affecting the 6 months survival

  first day of opportunistic infection

• Incidence of specific opportunistic infections in different host groups

  evolution of a 20-year-period

Study Arms (2)

Opportunistic infection

Immunocompromised or frail patients with an opportunistic infection

Control group

Immunocompromised or frail patients with no opportunistic infection

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Opposition of the patient to use his personal data

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases; Immunologic Deficiency Syndromes; Critical Illness

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul HERBRECHT, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul HERBRECHT, MD

CONTACT

03 88 12 83 79; raoul.herbrecht@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: April 19, 2019
• Study Start: March 15, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: April 19, 2019

Record last verified: 2018-09

Locations

FR (1)