The Value of F-18-fluorodeoxyglucose positron emission tomography for detection of metastatic infectious foci complicating Gram-positive bacteremia.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR951
• Date of registration: 11/04/2007
• Primary sponsor: University Medical Center St. Radboud, Department of Nuclear Medicine
• Public title: The Value of F-18-fluorodeoxyglucose positron emission tomography for detection of metastatic infectious foci complicating Gram-positive bacteremia.
• Scientific title: The Value of F-18-fluorodeoxyglucose positron emission tomography for detection of metastatic infectious foci complicating Gram-positive bacteremia. - MI-PET
• Date of first enrolment: 1/11/2005
• Target sample size: 115
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=951
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: F.J. Vos

• Name: F.J. Vos

Key inclusion & exclusion criteria

Inclusion criteria: 1. All patients with blood cultures containing one of the following microorganisms:

a. S. aureus;

b. Streptococcus spp (excluding S. pneumoniae);

c. Enterococcus spp.

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 hrs before initiation of appropriate treatment;

c. Skin lesions or other symptoms or signs pointing to possible metastatic infection;

d. Fever lasting for more than72 hrs after initiation of appropriate treatment;

e. Positive blood cultures for more than 48 hrs after initiation of appropriate treatment;

3. Informed consent.
Exclusion criteria: 1. Age less than 18 years;

2. Polymicrobial infection;

3. Pregnancy;

4. Critically ill patients initially admitted to the ICU department for more than 14 days;

5. Chemotherapeutically induced neutropenia.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Infection, Fluor-18-deoxyglucose (FDG-PET) , Bacteremia, Endocarditis, Staphylococcus aureus, Streptococcus species, Enterococcus species

Intervention(s)

FDG-PET will be performed within 14 days after intiatiation 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 diagnositc procedures. Minimal patient follow-up will be untill 3 months after the first positive blood culture.
In the analysis every prospectively included patient will be matched to a historic control, according to the microorganism and the presence of specific risk factors summarized under "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.

Primary Outcome(s)

Relapse rate of infection.

Secondary Outcome(s)

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.

Secondary ID(s)

ISRCTN76425553

N/A

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development