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Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection

NCT ID: NCT07307651

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-07

Study Completion Date

2029-06-07

Brief Summary

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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

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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.

Conditions

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Infection Rickettsia Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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retrospective cohort

No interventions assigned to this group

prospective cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* pazienti che presentano escara
* pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status

AUSL di Bologna

Bologna, Bologna, Italy

Site Status

Countries

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Italy

Central Contacts

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Silvia Galli

Role: CONTACT

Phone: +39 0512144450

Email: [email protected]

Giulio Virgili, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Giulio Virgili

Role: primary

References

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Giulieri S, Jaton K, Cometta A, Trellu LT, Greub G. Development of a duplex real-time PCR for the detection of Rickettsia spp. and typhus group rickettsia in clinical samples. FEMS Immunol Med Microbiol. 2012 Feb;64(1):92-7. doi: 10.1111/j.1574-695X.2011.00910.x. Epub 2011 Dec 12.

Reference Type RESULT
PMID: 22098502 (View on PubMed)

Brouqui P, Bacellar F, Baranton G, Birtles RJ, Bjoersdorff A, Blanco JR, Caruso G, Cinco M, Fournier PE, Francavilla E, Jensenius M, Kazar J, Laferl H, Lakos A, Lotric Furlan S, Maurin M, Oteo JA, Parola P, Perez-Eid C, Peter O, Postic D, Raoult D, Tellez A, Tselentis Y, Wilske B; ESCMID Study Group on Coxiella, Anaplasma, Rickettsia and Bartonella; European Network for Surveillance of Tick-Borne Diseases. Guidelines for the diagnosis of tick-borne bacterial diseases in Europe. Clin Microbiol Infect. 2004 Dec;10(12):1108-32. doi: 10.1111/j.1469-0691.2004.01019.x.

Reference Type RESULT
PMID: 15606643 (View on PubMed)

Related Links

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https://www.epicentro.iss.it/zecche/FebbreBottonosa2001-2015

Related Info

https://doi.org/10.1016/j.ttbdis.2018.09.001

Related Info

Other Identifiers

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Rickettsia2024

Identifier Type: -

Identifier Source: org_study_id