Condition category
Infections and Infestations
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
05/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J.A.J.W. Kluytmans

ORCID ID

Contact details

Vrije University Medical Centre
Department of Medical Microbiology and Infection Control
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0552
jan.kluytmans@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PATHOS study

Study hypothesis

To identify candidate antigens for the development of a prophylactic Staphylococcus aureus vaccine by studying expression profiles of host and pathogen determinants during natural infection.

Ethics approval

Not provided at time of registration

Study design

Multicentre, non-randomised, non-controlled, single armed clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Staphylococcus aureus infection and vaccination

Intervention

Blood will be drawn at days 2, 7 and 14 after the moment that the initial blood and wound cultures were obtained. This will be done simultaneously to drawing blood for routine haematology and chemistry investigations according good clinical practice, so no extra venapuncture is required for participation in the study. At day 2 two nasal swabs will be obtained for assessment of Staphylococcus aureus nasal carriage.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Putative antigen targets for the development of a Staphylococcus aureus vaccine.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2007

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (greater than 18 years) with S. aureus bacteraemia or wound infection
2. Diagnosis of S. aureus infection within 48 hours after initial cultures
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Incapacitated patients (Glasgow Coma Scale [GSC] less than 15)
2. Patients with neutropenia (less than 500x 10^6 neutrophils/L)
3. Patients with haematological malignancy
4. Transplantation patients
5. Patients who are treated with immunosuppressive drugs

Recruitment start date

01/11/2007

Recruitment end date

01/03/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Wyeth Pharmaceuticals B.V. (The Netherlands)

Sponsor details

P.O. Box 255
Hoofddorp
2130 AG
Netherlands
+31 (0)23 567 2567
info-nl@wyeth.com

Sponsor type

Industry

Website

http://www.wyeth.nl/

Funders

Funder type

Industry

Funder name

Wyeth Pharmaceuticals B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes