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出境医 / 临床实验 / Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
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
| Condition or disease |
|---|
| Hematologic Disease Neoplams Transplantation Immunologic Deficiency Syndromes Critical Illness |
Study Design
| 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 |
Arms and Interventions
| Group/Cohort |
|---|
|
Opportunistic infection
Immunocompromised or frail patients with an opportunistic infection
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Control group
Immunocompromised or frail patients with no opportunistic infection
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Outcome Measures
Primary Outcome Measures :
- Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Long-term time point : 1st may 2019 ]
- Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 1 month ]
- Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 3 months ]
- Short- and long-term survival, overall and in specific subgroups of patients [ Time Frame: Short term : 6 months ]
Secondary Outcome Measures :
- Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use [ Time Frame: 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) [ Time Frame: first day of opportunistic infection ]
- Identification of baseline prognosis factors affecting the 3 months survival [ Time Frame: first day of opportunistic infection ]
- Identification of baseline prognosis factors affecting the 6 months survival [ Time Frame: first day of opportunistic infection ]
- Incidence of specific opportunistic infections in different host groups [ Time Frame: 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 [ Time Frame: at first day of infection and up to 12 weeks ]
- Assessment of performance of Aspergillus galactomannan detection test in serum [ Time Frame: at onset and up to 1 week ]
- Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage [ Time Frame: at onset and up to 1 week ]
- Response rate [ Time Frame: at 1, 3 and 6 months ]
Eligibility Criteria
| 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
Contacts
| Contact: Raoul HERBRECHT, MD | 03 88 12 83 79 ext 0033 | raoul.herbrecht@chru-strasbourg.fr |
Locations
| 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
| Principal Investigator: | Raoul HERBRECHT, MD | University Hospital, Strasbourg, France |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | August 6, 2018 | ||||
| First Posted Date | April 19, 2019 | ||||
| Last Update Posted Date | April 19, 2019 | ||||
| Actual Study Start Date | March 15, 2017 | ||||
| Estimated Primary Completion Date | July 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients | ||||
| Official Title | Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients | ||||
| 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 |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
1000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 15, 2019 | ||||
| Estimated Primary Completion Date | July 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion criteria:
Exclusion criteria: - Opposition of the patient to use his personal data |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03920735 | ||||
| Other Study ID Numbers | 1INFOPP | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor | University Hospital, Strasbourg, France | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Hospital, Strasbourg, France | ||||
| Verification Date | September 2018 | ||||
