| - candidate number | 2545 |
| - NTR Number | NTR951 |
| - ISRCTN | ISRCTN76425553 |
| - Date ISRCTN created | 2-mei-2007 |
| - date ISRCTN requested | 20-apr-2007 |
| - Date Registered NTR | 11-apr-2007 |
| - Secondary IDs | N/A |
| - 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. |
| - ACRONYM | MI-PET |
| - hypothesis | FDG-PET enables early and more accurate diagnosis of metastatic infection, resulting in a reduction of the number of relapses. |
| - Healt Condition(s) or Problem(s) studied | Infection, Fluor-18-deoxyglucose (FDG-PET) , Bacteremia, Endocarditis, Staphylococcus aureus, Streptococcus species, Enterococcus species |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-nov-2005 |
| - planned closingdate | 1-nov-2007 |
| - Target number of participants | 115 |
| - Interventions | 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 | Relapse rate of infection. |
| - Secondary outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. F.J. Vos |
| - CONTACT for SCIENTIFIC QUERIES | Drs. F.J. Vos |
| - Sponsor/Initiator | University Medical Center St. Radboud, Department of Nuclear Medicine |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | - Cuijpers et al, Complicating infectious foci in patients with Staphylococcus aureus or Streptococcus species bacteraemia. Eur J Clin Microbiol Infect Dis 2007:105-113; - Bleeker-Rovers et al, 18F-FDG PET in detecting metastatic infectious disease. J.Nucl Med 2005:2014-2019. |
| - Brief summary | Timely identification of metastatic infection, an important complication of Gram positive bacteremia, is difficult because up to 30% of foci lack guiding symptoms. Metastatic foci often need prolonged treatment or drainage. As FDG accumulates in infectious lesions it is hypothesized that FDG-PET enables early and more accurate diagnosis of metastatic infection, resulting in a reduction of the number of relapses. |
| - Main changes (audit trail) | |
| - RECORD | 11-apr-2007 - 13-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl