Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- To evaluate the early diagnostic capability of molecular testing (RT-PCR) for the diagnosis of Rickettsia infection at the time of first blood sampling in suspected cases.
Study Overview
Brief Summary
Rickettsia2024 is a multicenter, tissue observational, retrospective and prospective cohort study. Enrollment will take place within the outpatient clinics of the Infectious Diseases and Dermatology Unit of the IRCCS AOUBO and, following an infectious disease consultation in the Bologna Metropolitan area, at the Hospitals and CAUs of the Bologna Local Health Authority. Within these UUOOs, biopsy samples from normal clinical practice are performed on patients with strong clinical suspicion of Rickettsia infection: therefore, it will not be necessary to perform any additional samples for the conduct of this study. Samples from the normal diagnostic process are sent to the Microbiology UOC, where they are subjected to various analyses. RT-PCR analyses (commercial or in-house kit) and assay of species-specific IgG antibodies will be performed according to clinical practice. Additional tests will be performed with a commercial kit for retrospective samples and with a home-made method for prospective samples.
Detailed Description
It is estimated that a total of approximately 800 patients can be recruited, 400 for the retrospective part and the same number for the prospective part (estimated using data collected from requests received to date). For the retrospective cohort: from January 2023 until approval by the ethics committee; For the prospective cohort: from ethics committee approval until December 2027.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pazienti che presentano escara
- •pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To evaluate the early diagnostic capability of molecular testing (RT-PCR) for the diagnosis of Rickettsia infection at the time of first blood sampling in suspected cases.
Time Frame: from January 7, 2026 to June 7, 2028
Secondary Outcomes
- Estimation of the incidence of Rickettsia conorii infections in the Bologna metropolitan area through serological screening(from January 7, 2026 to June 7, 2028)
- Comparison of the sensitivity and specificity of diagnosis of in-house RT-PCR and commercial kit (Rickettsia spp REAL TIME PCR, Immunospark)(from January 7, 2026 to June 7, 2028)
- Identification of Rickettsia species by gene sequencing of the 16S rRNA portion of samples tested positive (threshold cycle < 30) by in-house RT-PCR/commercial kit(from January 7, 2026 to June 7, 2028)