Drug Resistant Bacterial Infection
Conditions
Brief summary
Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank. The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR. The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM.
Interventions
DIAGNOSTIC_TESTARES PCR
Real time PCR assays will be used for the identification of infecting microorganisms and the drug resistance they carry that allow their identification, such as KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR. The validation of the method will be carried out in 100 (based on availability in Tropica Biobank) clinical samples: blood n=50 (positive, as for the negatives reference will be made to those already provided in the GENRES study) and rectal swabs ( positive n=40 and negative n=10) provided by the DITM. Sensitivity and specificity will be analyzed. As a reference for positivity and negativity data, reference will be made to routine diagnostic data obtained through standard operating procedures at the DITM laboratories.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital * Samples for which the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank has been signed
Exclusion criteria
* Absence of data relating to positivity or negativity to the germs of interest * Absence of stored residual material * Absence of information and consent to the conservation of biological samples for signed research purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCR results | Baseline | Results (positive/negative and microorganism identification) obtained by real time PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gene mutations | Baseline | Results (resistant/susceptible) obtained by real time PCR in the identification of gene mutations that convey resistance to antibiotics. |
Countries
Italy
Outcome results
None listed