Contact information
Type
Scientific
Primary contact
Dr F.J. Vos
ORCID ID
Contact details
Radboud University Nijmegen Medical Centre
Department of Internal Medicine
463
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
31 (0)24 361 4763
F.Vos@AIG.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MI-PET
Study hypothesis
F-18-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) enables early and more accurate diagnosis of metastatic infection, resulting in a reduction of the number of relapses.
Ethics approval
Approval received from the local ethics board (CMO Regio Arnhem-Nijmegen at UMC St Radboud) on the 18th October 2005 (ref: CMO-nr:2005/149).
Study design
Multicentre, non-randomised, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Metastatic infection/ gram-positive bacteraemia
Intervention
FDG-PET will be performed within 14 days after initiation of treatment. The attending physician will be informed of the results of FDG-PET immediately. Special attention will be paid to confirmation of FDG-PET results with conventional diagnostic procedures. Minimal patient follow-up will be until three months after the first positive blood culture.
In the analysis every prospectively included patient will be matched to a historic control, according to the micro-organism and the presence of specific risk factors summarised under the inclusion criteria. These historic controls are enrolled from the database of the department of Microbiology in our hospital between January 2000 and December 2004. All relevant data of this historic control group are retrieved from the patients charts and the hospitals electronic databases before patients are matched.
The retrospective database (control group) is expected to be completed June 2007. Matching between our prospective and retrospective patients will be three months after end of recruitment, in order to have a minimal three-month follow-up in all patients.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Relapse rate of infection
Secondary outcome measures
1. Attributable mortality
2. Mortality after relapse
3. Duration of first admission
4. Duration of antibiotic treatment
5. Number of diagnostic procedures performed to confirm metastatic foci, duration of admission due to relapse
6. Associated costs
Overall trial start date
01/11/2005
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients with blood cultures containing one of the following micro-organisms:
a. Streptococcus aureus
b. Streptococcus species (excluding S. pneumoniae)
c. Enterococcus species
2. AND at least one of the following risk factors for metastatic infection:
a. Community acquired infection
b. Signs of infection for more than 48 hours before initiation of appropriate treatment
c. Skin lesions or other symptoms or signs pointing to possible metastatic infection
d. Fever lasting for more than 72 hours after initiation of appropriate treatment
e. Positive blood cultures for more than 48 hours after initiation of appropriate treatment
3. Informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
115
Participant exclusion criteria
1. Age less than 18 years
2. Polymicrobial infection
3. Pregnancy
4. Critically ill patients initially admitted to the Intensive Care Unit (ICU) department for more than 14 days
5. Chemotherapeutically induced neutropenia
Recruitment start date
01/11/2005
Recruitment end date
01/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Centre St. Radboud (The Netherlands)
Sponsor details
Department of Nuclear Medicine
Nijmegen
6500 HB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (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
Basic results (scientific)
Publication list
Results on:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17211607
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16330565
Publication citations
-
Cuijpers ML, Vos FJ, Bleeker-Rovers CP, Krabbe PF, Pickkers P, van Dijk AP, Wanten GJ, Sturm PD, Oyen WJ, Kullberg BJ, Complicating infectious foci in patients with Staphylococcus aureus or Streptococcus species bacteraemia., Eur. J. Clin. Microbiol. Infect. Dis., 2007, 26, 2, 105-113, doi: 10.1007/s10096-006-0238-4.
-
Bleeker-Rovers CP, Vos FJ, Wanten GJ, van der Meer JW, Corstens FH, Kullberg BJ, Oyen WJ, 18F-FDG PET in detecting metastatic infectious disease., J. Nucl. Med., 2005, 46, 12, 2014-2019.