Analyses of PAThogen and HOSt determinants in hospitalised patients with a laboratory confirmed infection caused by Staphylococcus aureus: the PATHOS study

ISRCTN	ISRCTN19709160
DOI	https://doi.org/10.1186/ISRCTN19709160
Protocol serial number	N/A
Sponsor	Wyeth Pharmaceuticals B.V. (The Netherlands)
Funder	Wyeth Pharmaceuticals B.V. (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof J.A.J.W. Kluytmans
Scientific

Vrije University Medical Centre
Department of Medical Microbiology and Infection Control
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 0552
Email	jan.kluytmans@vumc.nl

Primary study design	Interventional
Study design	Multicentre, non-randomised, non-controlled, single armed clinical trial
Secondary study design	Non randomised controlled trial
Scientific title
Study acronym	PATHOS study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Putative antigen targets for the development of a Staphylococcus aureus vaccine.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/03/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	01/03/2007

Vrije University Medical Centre

Amsterdam
1007 MB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan