Completed

NCT Number: NCT01931800

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

* 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.

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Key information

Conditions

Invasive Pneumococcic

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sampling of blood

Biological

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Hyalo strepto

Important dates

Study start: 2005
Primary completion: 2015
Study completion: 2015
First posted: Aug 29, 2013
Registry last updated: Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.