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

NCT07307651 | Not Yet Recruiting

• 1 other identifier: Rickettsia2024
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

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.

Conditions

Infection; Rickettsia Infections

Outcome Measures

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.

  from January 7, 2026 to June 7, 2028

Secondary Outcomes (3)

• 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

• Estimation of the incidence of Rickettsia conorii infections in the Bologna metropolitan area through serological screening

  from January 7, 2026 to June 7, 2028

Study Arms (2)

retrospective cohort

prospective cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

AUSL di Bologna

Bologna, Bologna, Italy

Location

Related Publications (2)

• 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.

  PMID: 22098502 RESULT

• 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.

  PMID: 15606643 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Infections; Rickettsia Infections

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vector Borne Diseases

Central Study Contacts

Silvia Galli

CONTACT

+39 0512144450; silvia.galli@aosp.bo.it

Giulio Virgili, MD

CONTACT

giulio.virgili@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): June 7, 2028
• Study Completion (Estimated): June 7, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

IT (2)