Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae

Infections, Streptococcal Clinical Trial

Official title:

An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523770
• Other study ID #: BACDU-001
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: February 7, 2017
• Start date: September 2007

Study information

• Verified date: February 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female between, and including, 65 and 85 years of age at the time of the study.

• Written informed consent obtained from the subject

• Healthy subjects as established by medical history and clinical examination before entering into the study

Exclusion Criteria:

• Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,

• History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start

Related Conditions & MeSH terms

• Infections, Streptococcal
• Pneumonia
• Streptococcal Infections

Intervention

Procedure:
• Urine sample collection
Urine samples will be collected and tested for the presence of S. pneumoniae

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive or negative result using Binax NOW S. pneumoniae Test		within one day
Secondary	Positive or negative result using the test to be developed for typing of S. pneumoniae		within one day
Secondary	Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)		within one day