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

NCT00523770 | Completed

• 1 other identifier: BACDU-001
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Infections, Streptococcal

Keywords

Invasive Pneumococcal Diseases; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Positive or negative result using Binax NOW S. pneumoniae Test

  within one day

Secondary Outcomes (2)

• Positive or negative result using the test to be developed for typing of S. pneumoniae

  within one day

• Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)

  within one day

Study Arms (1)

Group A

Non-pneumococcal infected healthy elderly volunteers

Procedure: Urine sample collection

Interventions

Urine sample collection PROCEDURE

Urine samples will be collected and tested for the presence of S. pneumoniae

Group A

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of Belgium and Finland

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample

MeSH Terms

Conditions

Streptococcal Infections; Pneumonia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Last Updated: February 9, 2017

Record last verified: 2017-02