Condition category
Infections and Infestations
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

http://www.umcn.nl/homepage

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes