Invasive PneumococcicHyalo streptoNCT01931800
Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae
An observational study of Invasive Pneumococcic, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient within 24 hours following inclusion (D0) in the department in which the patient is hospitalised 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Invasive Pneumococcic
- What is being tested?
- Sampling of blood
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2005to 27 Jan 2015
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients hospitalized in a service, for whom a sampling "targets" (hémoculture, cerebrospinal fluid, bronchial brush, liquid of broncho-alveolar wash, protected tracheal aspiration) with positive culture to Streptococcus pneumoniae.
Who may be able to join
- Patients (children or adults) hospitalised at Dijon CHU
- Presenting invasive pneumococcal disease, confirmed by:
- The presence of Streptococcus pneumoniae in a blood culture, or The presence of Streptococcus pneumoniae in a sample of cerebrospinal fluid, or The presence of significant levels of Streptococcus pneumoniae in an endobronchial sample (bronchial brushing or bronchoalveolar lavage), or in protected tracheal aspirations or in the spit of non-hospitalised patients or those in Intensive care Units.
Who cannot join
- Patients in whom the implication of Streptococcus pneumoniae is suspected because of: positive urinary soluble antigen of Streptococcus pneumoniae with the exclusion of any other positive sample, presence of non- significant levels of Streptococcus pneumoniae in bronchopulmonary samples The presence of significant levels of Streptococcus pneumoniae in protected tracheal aspirations or in the spit, with the exclusion of any other positive sample in patients who had been in an Intensive care Unit for more than 48 hours at the time the sample was taken.
- Patients in whom Streptococcus pneumoniae had already been isolated in the 5 weeks preceding inclusion in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient within 24 hours following inclusion (D0) in the department in which the patient is hospitalised
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient every 7 days following inclusion for 5 weeks (if the patient is still in hospital at the time), in the department where he/she is hospitalised (D7, D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU, even if all of the samples have not been taken.
- For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose, and 1x5 ml tube with blue CTAD) will be taken following the same timetable.
- For hospitalised patients, a leeway of 48 hours is authorized for the sampling procedure. Samples will be taken at the same time samples are taken for the usual care of the patient.
- The tubes will be taken to the Bacteriology Laboratory using the usual collection circuit of the CHU. These tubes will then be redirected to the Infectious Diseases Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus pneumoniae isolated in the patient will be preserved at -80°C. If strains other than Streptococcus pneumoniae are isolated, these different strains will all be preserved at -80°C under the same identification number.
- Conditions
- Invasive Pneumococcic
- Being tested
- Sampling of blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of bloodBiological
| Study group | Role | What they receive |
|---|---|---|
| Presenting patients a pneumonia pneumococcique | Not described Receives: Biological: Sampling of blood | |
| Patients presenting a bacteremia pneumococcique | Not described Receives: Biological: Sampling of blood | |
| Patients affected by pneumococcique meningitis | Not described Receives: Biological: Sampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae
Measured: In the visit of inclusion then every 7 days during all the duration of patient hospitalization
Secondary outcomes (1)
Quantification of hyaluronidase expression in strains of Streptococcus pneumoniae
Measured: In the visit of inclusion then every 7 days during all the duration of his hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start6 Jan 2005
- Primary completion27 Jan 2015
- Study completion27 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive PneumococcicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931800
- Sponsor's protocol ID
- PIROTH PHRC R 2004
- Acronym
- Hyalo strepto
- Status last verified
- Jul 2019
- First submitted
- 27 Aug 2013
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae
- ClinicalTrials.gov ID
- NCT01931800
- Acronym / sponsor ID
- Hyalo strepto / PIROTH PHRC R 2004
- Conditions
- Invasive Pneumococcic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Jan 2005 (actual)
- Primary completion
- 27 Jan 2015 (actual)
- Study completion
- 27 Jan 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- 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.
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient within 24 hours following inclusion (D0) in the department in which the patient is hospitalised
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient every 7 days following inclusion for 5 weeks (if the patient is still in hospital at the time), in the department where he/she is hospitalised (D7, D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU, even if all of the samples have not been taken.
- For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose, and 1x5 ml tube with blue CTAD) will be taken following the same timetable.
- For hospitalised patients, a leeway of 48 hours is authorized for the sampling procedure. Samples will be taken at the same time samples are taken for the usual care of the patient.
- The tubes will be taken to the Bacteriology Laboratory using the usual collection circuit of the CHU. These tubes will then be redirected to the Infectious Diseases Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus pneumoniae isolated in the patient will be preserved at -80°C. If strains other than Streptococcus pneumoniae are isolated, these different strains will all be preserved at -80°C under the same identification number.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Presenting patients a pneumonia pneumococcique | – | Biological: Sampling of blood |
| Patients presenting a bacteremia pneumococcique | – | Biological: Sampling of blood |
| Patients affected by pneumococcique meningitis | – | Biological: Sampling of blood |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients hospitalized in a service, for whom a sampling "targets" (hémoculture, cerebrospinal fluid, bronchial brush, liquid of broncho-alveolar wash, protected tracheal aspiration) with positive culture to Streptococcus pneumoniae.
Key inclusion criteria (3 listed)
- Patients (children or adults) hospitalised at Dijon CHU
- Presenting invasive pneumococcal disease, confirmed by:
- The presence of Streptococcus pneumoniae in a blood culture, or The presence of Streptococcus pneumoniae in a sample of cerebrospinal fluid, or The presence of significant levels of Streptococcus pneumoniae in an endobronchial sample (bronchial brushing or bronchoalveolar lavage), or in protected tracheal aspirations or in the spit of non-hospitalised patients or those in Intensive care Units.
Key exclusion criteria (2 listed)
- Patients in whom the implication of Streptococcus pneumoniae is suspected because of: positive urinary soluble antigen of Streptococcus pneumoniae with the exclusion of any other positive sample, presence of non- significant levels of Streptococcus pneumoniae in bronchopulmonary samples The presence of significant levels of Streptococcus pneumoniae in protected tracheal aspirations or in the spit, with the exclusion of any other positive sample in patients who had been in an Intensive care Unit for more than 48 hours at the time the sample was taken.
- Patients in whom Streptococcus pneumoniae had already been isolated in the 5 weeks preceding inclusion in the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of blood | Biological | Patients affected by pneumococcique meningitis, Patients presenting a bacteremia pneumococcique, Presenting patients a pneumonia pneumococcique |
Primary outcome
Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae
Time frame: In the visit of inclusion then every 7 days during all the duration of patient hospitalization
1 secondary outcome
Quantification of hyaluronidase expression in strains of Streptococcus pneumoniae
Time frame: In the visit of inclusion then every 7 days during all the duration of his hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Invasive Pneumococcic, run by Centre Hospitalier Universitaire Dijon 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 2 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: finished, as of the sponsor's last update on 24 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae (time frame: In the visit of inclusion then every 7 days during all the duration of patient hospitalization). 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 24 Jul 2019.