The value of F-18-fluorodeoxyglucose Positron Emission Tomography for detection of Metastatic Infectious foci complicating gram-positive bacteraemia

ISRCTN ISRCTN76425553
DOI https://doi.org/10.1186/ISRCTN76425553
Submission date
02/05/2007
Registration date
02/05/2007
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F.J. Vos
Scientific

Radboud University Nijmegen Medical Centre
Department of Internal Medicine, 463
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone 31 (0)24 361 4763
Email F.Vos@AIG.umcn.nl

Study information

Study designMulticentre, non-randomised, controlled, parallel group trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe value of F-18-fluorodeoxyglucose Positron Emission Tomography for detection of Metastatic Infectious foci complicating gram-positive bacteraemia
Study acronymMI-PET
Study objectivesF-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(s)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).
Health condition(s) or problem(s) studiedMetastatic infection/ gram-positive bacteraemia
InterventionFDG-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 typeOther
Primary outcome measureRelapse rate of infection
Secondary outcome measures1. 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 study start date01/11/2005
Completion date01/11/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants115
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2005
Date of final enrolment01/11/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Centre St. Radboud (The Netherlands)
Hospital/treatment centre

Department of Nuclear Medicine
Nijmegen
6500 HB
Netherlands

Website http://www.umcn.nl/homepage
ROR logo "ROR" https://ror.org/05wg1m734

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications 01/12/2005 Yes No
Other publications 01/02/2007 Yes No
Results article 01/03/2012 25/10/2022 Yes No

Editorial Notes

25/10/2022: Publication reference added.