InfectionNCT07307651
Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection
An observational study of Infection and Rickettsia Infections, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Rickettsia Infections
- How many people
- 800 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Jan 2026to 7 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- pazienti che presentano escara
- pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giulio Virgili, MD contact
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
AUSL di Bologna
Bologna, Bologna
Giulio Virgili, giulio.virgili@aosp.bo.it
About this study
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.
Read the 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.
- Conditions
- Infection, Rickettsia Infections
- Medical subject headings
- Infections, Rickettsia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retrospective cohort | Not described | |
| prospective cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: from January 7, 2026 to June 7, 2028
Estimation of the incidence of Rickettsia conorii infections in the Bologna metropolitan area through serological screening
Measured: from January 7, 2026 to June 7, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start7 Jan 2026 (estimated)
- Primary completion7 Jun 2028 (estimated)
- Study completion7 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307651
- Sponsor's protocol ID
- Rickettsia2024
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22098502Brouqui 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.
PubMed 15606643
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection
- ClinicalTrials.gov ID
- NCT07307651
- Acronym / sponsor ID
- Rickettsia2024
- Conditions
- Infection, Rickettsia Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Jan 2026 (estimated)
- Primary completion
- 7 Jun 2028 (estimated)
- Study completion
- 7 Jun 2029 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort | – | – |
| prospective cohort | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- pazienti che presentano escara
- pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 22098502Giulieri 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.
- Results publication: PubMed 15606643Brouqui 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulio Virgili, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Rickettsia Infections, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Galli (+39 0512144450, silvia.galli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307651, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.