NCT00637351

Brief Summary

GSK Biologicals is working on the development of a vaccine to protect elderly people from bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future studies in that project, it would be useful to have some easy non invasive tests. New clinical read-outs are needed to detect and identify the causative pathogen. These assays will be based on specific antigen detection in the urine or specific pathogen DNA detection in the blood. Technical and clinical validation of these assays will be realised at later stage with samples coming from epidemiological and/or phase III studies. To allow the development of such tests in GSK Biologicals laboratories, urine and blood samples are needed from subjects aged 65 or above who have diagnosed pneumonia. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

March 10, 2008

Last Update Submit

January 9, 2014

Conditions

Infections, Streptococcal

Outcome Measures

Primary Outcomes (2)

  • Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.

    At the time of analysis.

  • Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.

    At the time of analysis.

Secondary Outcomes (2)

  • Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.

    At the time of analysis.

  • Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.

    At the time of analysis.

Study Arms (2)

Group A

Subjects with diagnosed pneumonia \& positive culture of streptococcus pneumoniae

Procedure: Blood sampleProcedure: Urine sample

Group B

Subjects with diagnosed pneumonia \& positive culture of non-typable haemophilus influenzae

Procedure: Blood sampleProcedure: Urine sample

Interventions

Blood samplePROCEDURE

One blood sample will be collected at the time of screening for subjects

Group AGroup B
Urine samplePROCEDURE

One urine sample will be collected at the time of screening for subjects

Group AGroup B

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly subjects with diagnosed pneumonia

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 aged 65 or above at the time of the study.
  • Written informed consent obtained from the subject.
  • Clinical pneumonia diagnosed by chest X-ray detected within 7 days before study entry.

You may not qualify if:

  • Vaccination with a pneumococcal or Haemophilus vaccine within the last 3 months before study entry.
  • Antibiotherapy started more than 7 days before Screening.
  • A negative culture for Streptococcus pneumoniae or Non-Typable Haemophilus influenza.
  • A urine sample at Screening less than 40 mL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Yvoir, 5330, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine samples

MeSH Terms

Conditions

Streptococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 18, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

BE(2)