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

Invasive Pneumococcic Clinical Trial

— Hyalo strepto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931800
• Other study ID #: PIROTH PHRC R 2004
• Status: Completed
• Start date: January 6, 2005
• Est. completion date: January 27, 2015

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 27, 2015
• Est. primary completion date: January 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Pneumococcic
• Pneumonia

Intervention

Biological:
• Sampling of blood

Locations

Country	Name	City	State
France	CHU Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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