Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pazienti che presentano escara
pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii
Disqualifiers
None
Trial population
The study population will consist of patients belonging to the UUOOs involved in the study, for whom serum samples, whole blood, skin biopsy, eschar, vesicle buffer underlying the eschar collected through withdrawals that meet the inclusion criteria, performed according to clinical practice, are available: * For the retrospective cohort: from January 2023 until approval by the ethics committee; * For the prospective cohort: from ethics committee approval until December 2027. The Microbiology Unit is the operational reference unit. The Infectious Diseases and Dermatology Unit of the IRCCS AOUBO is involved in patient enrollment, as are the Hospitals and CAUs of the Bologna Local Health Authority, following requests for infectious disease counseling in the Bologna Metropolitan Area.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 2 trial groupsGroup A: retrospective cohort
Group B: prospective cohort
Trial outcomes
Primary outcomes
1
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, 2028Secondary outcomes
1
Comparison of the sensitivity and specificity of diagnosis of in-house RT-PCR and commercial kit (Rickettsia spp REAL TIME PCR, Immunospark)
Time frame
from January 7, 2026 to June 7, 20282
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
Time frame
from January 7, 2026 to June 7, 20283
Estimation of the incidence of Rickettsia conorii infections in the Bologna metropolitan area through serological screening
Time frame
from January 7, 2026 to June 7, 2028Sponsors and contacts
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Source ClinicalTrials.gov
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