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Not yet recruiting NCT07307651

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

— Observational Infection Rickettsia Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Infection, Rickettsia Infections. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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 outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
  • AUSL di Bologna — Bologna

Publications

  • 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
  • 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 PMID 15606643

Identifiers

NCT: NCT07307651 · Rickettsia2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗