Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae

NCT01931800 | Completed

• 1 other identifier: PIROTH PHRC R 2004
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae

  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

  In the visit of inclusion then every 7 days during all the duration of his hospitalization

Study Arms (3)

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

Interventions

Sampling of blood BIOLOGICAL

Patients affected by pneumococcique meningitis; Patients presenting a bacteremia pneumococcique; Presenting patients a pneumonia pneumococcique

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon

Dijon, 21000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 29, 2013
• Study Start: January 6, 2005
• Primary Completion: January 27, 2015
• Study Completion: January 27, 2015
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

FR (1)