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

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

• Registration Number: NCT03920735
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2018-08-06
• Status Verified: 2018-09
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-19
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short- and long-term survival, overall and in specific subgroups of patients	Short term : 6 months

Secondary Outcome Measures

Name	Time	Method
Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use	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
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
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
Response rate	at 1, 3 and 6 months
Incidence of specific opportunistic infections in different host groups	evolution of a 20-year-period
Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage	at onset and up to 1 week

Trial Locations

Locations (1)

University Hospital, Strasbourg, france; 🇫🇷 Strasbourg, France