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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University Medical Centre St. Radboud (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
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 |
|---|---|
| F.Vos@AIG.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, non-randomised, controlled, parallel group trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | The value of F-18-fluorodeoxyglucose Positron Emission Tomography for detection of Metastatic Infectious foci complicating gram-positive bacteraemia |
| Study acronym | MI-PET |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Relapse rate of infection |
| Key secondary outcome measure(s) |
1. Attributable mortality |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 115 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2012 | 25/10/2022 | Yes | No | |
| Other publications | 01/12/2005 | Yes | No | ||
| Other publications | 01/02/2007 | Yes | No |
Editorial Notes
25/10/2022: Publication reference added.
