NCT06308692

Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Resistant Bacterial Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ARES 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.

Timeline

• Start date: 2022-06-28
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Italy