Hematologic DiseaseNCT03920735
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
An observational study of Hematologic Disease and Neoplams, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Disease, Neoplams, Transplantation
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2017to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Opposition of the patient to use his personal data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Strasbourg, france
Strasbourg, 67091
Raoul HERBRECHT, MD, 03 88 12 83 79 ext. 0033, raoul.herbrecht@chru-strasbourg.fr
Raoul Raoul, MD
About this study
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
- Medical subject headings
- Hematologic Diseases, Immunologic Deficiency Syndromes, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opportunistic infection | Immunocompromised or frail patients with an opportunistic infection | |
| Control group | Immunocompromised or frail patients with no opportunistic infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short- and long-term survival, overall and in specific subgroups of patients
Measured: Long-term time point : 1st may 2019
Short- and long-term survival, overall and in specific subgroups of patients
Measured: Short term : 1 month
Short- and long-term survival, overall and in specific subgroups of patients
Measured: Short term : 3 months
Short- and long-term survival, overall and in specific subgroups of patients
Measured: Short term : 6 months
Secondary outcomes (9)
Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use
Measured: 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)
Measured: first day of opportunistic infection
Identification of baseline prognosis factors affecting the 3 months survival
Measured: first day of opportunistic infection
Identification of baseline prognosis factors affecting the 6 months survival
Measured: first day of opportunistic infection
Incidence of specific opportunistic infections in different host groups
Measured: 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
Measured: at first day of infection and up to 12 weeks
Assessment of performance of Aspergillus galactomannan detection test in serum
Measured: at onset and up to 1 week
Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage
Measured: at onset and up to 1 week
Response rate
Measured: at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start15 Mar 2017
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul HERBRECHT, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920735
- Sponsor's protocol ID
- 1INFOPP
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
- ClinicalTrials.gov ID
- NCT03920735
- Acronym / sponsor ID
- 1INFOPP
- Conditions
- Hematologic Disease, Neoplams, Transplantation, Immunologic Deficiency Syndromes, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opportunistic infection | – | –Immunocompromised or frail patients with an opportunistic infection |
| Control group | – | –Immunocompromised or frail patients with no opportunistic infection |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Opposition of the patient to use his personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul HERBRECHT, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Disease and Neoplams, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raoul HERBRECHT, MD (03 88 12 83 79 ext. 0033, raoul.herbrecht@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short- and long-term survival, overall and in specific subgroups of patients (time frame: Long-term time point : 1st may 2019). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.