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

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.

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Key information

Conditions

Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Rickettsia Infections Rickettsiaceae Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

AUSL di Bologna, Bologna, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

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

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, 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

Time frame: from January 7, 2026 to June 7, 2028
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, 2028

Study contacts

Contact information is provided by the study sponsor or research team.

Giulio Virgili, MD

CONTACT

[email protected]

Silvia Galli

CONTACT

[email protected]

+39 0512144450

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Dec 29, 2025
Registry last updated: Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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