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

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 Overview

• Status: Unknown
• Conditions: Immunologic Deficiency Syndromes; Critical Illness; Transplantation; Hematologic Disease; Neoplams

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Raoul HERBRECHT, MD; Phone Number: 0033 03 88 12 83 79; Email: raoul.herbrecht@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • University Hospital, Strasbourg, France
    • Contact: Raoul HERBRECHT, MD; Phone Number: 0033 03 88 12 83 79; Email: raoul.herbrecht@chru-strasbourg.fr
    • Principal Investigator: Raoul Raoul, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Opportunistic infection; Immunocompromised or frail patients with an opportunistic infection
Control group; Immunocompromised or frail patients with no opportunistic infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
Assessment of performance of Aspergillus galactomannan detection test in serum	at onset and up to 1 week
Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage	at onset and up to 1 week
Response rate	at 1, 3 and 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): July 15, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Immune System Diseases; Disease Attributes; Parasitic Diseases; Hematologic Diseases; Immunologic Deficiency Syndromes; Critical Illness; Opportunistic Infections
• Other Study ID Numbers: 1INFOPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No