- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01931800
Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae (Hyalo strepto)
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- CHU Dijon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Presenting patients a pneumonia pneumococcique
|
|
|
Patients presenting a bacteremia pneumococcique
|
|
|
Patients affected by pneumococcique meningitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
In the visit of inclusion then every 7 days during all the duration of patient hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
In the visit of inclusion then every 7 days during all the duration of his hospitalization
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIROTH PHRC R 2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.