TIBOLANCT05458245
TIBOLA : Multicenter Descriptive Study in Eastern France
An observational study of TIBOLA and Rickettsia Infections, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TIBOLA, Rickettsia Infections
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Definite case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) +/- tick bite noted AND microbiological proof (positive PCR or seroconversion for a microorganism responsible for TIBOLA) OR * Probable case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) AND tick bite noted without microbiological proof.
Who may be able to join
- Person, minor or major,
- having been diagnosed with TIBOLA
- between January 1, 2016 and December 31, 2021
- at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Yves Hansmann
Strasbourg, 67000
Yves Hansmann, MD PhD, +33369550545, Yves.Hansmann@chru-strasbourg.fr
- Recruiting
Elisabeth Baux
Vandœuvre-lès-Nancy, 54500
Elisabeth Baux, 0383153388, e.baux@chru-nancy.fr
About this study
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).
Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.
Read more
In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.
At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.
- Conditions
- TIBOLA, Rickettsia Infections
- Keywords
- dermacentor, DEBONEL
- Medical subject headings
- Spotted Fever Group Rickettsiosis, Rickettsia Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of TIBOLA
Measured: baseline
Secondary outcomes (6)
Epidemiological and demographic characteristics
gender, age, habitat, hobbies, occupation
Measured: baseline
Characteristics of tick bites
frequency, location, date
Measured: baseline
Frequency of the various symptoms and clinical signs of the disease
inoculation ulcer, alopecia, lymphadenopathy, asthenia, fever, rash, headache, arthromyalgia, pruritus, facial oedema, other
Measured: baseline
Biological results
serology and PCR of rickettsia, non-specific abnormalities
Measured: baseline
Treatment
nature, efficiency
Measured: baseline
Entomological analysis
respective proportion of Dermacentor and Ixodes encountered on the territory. Detection by molecular biology of the presence of Rickettsia spp. in ticks
Measured: evolution between 2016 and 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jun 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TIBOLAStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth BAUX, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458245
- Sponsor's protocol ID
- 2021PI121
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kotzyba J, Baux E, Hansmann Y, Boyer P, Jaulhac B, Martinot M, Martha B, Kaeuffer C, Bonijoly T, Bani-Sadr F, Legoff A, Hoefler F, Blot M, Bourdellon L, Zilliox L, Boulanger N, Lefevre B. Tick-borne lymphadenopathy in northeastern France: a human and vector clinical-epidemiological study. Parasit Vectors. 2025 Oct 24;18(1):428. doi: 10.1186/s13071-025-07078-2.
PubMed 41137175
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIBOLA : Multicenter Descriptive Study in Eastern France
- ClinicalTrials.gov ID
- NCT05458245
- Acronym / sponsor ID
- 2021PI121
- Conditions
- TIBOLA, Rickettsia Infections
- Keywords
- dermacentor, DEBONEL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).
Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.
In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.
At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Definite case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) +/- tick bite noted AND microbiological proof (positive PCR or seroconversion for a microorganism responsible for TIBOLA) OR * Probable case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) AND tick bite noted without microbiological proof.
Key inclusion criteria (4 listed)
- Person, minor or major,
- having been diagnosed with TIBOLA
- between January 1, 2016 and December 31, 2021
- at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.
Key exclusion criteria (0 listed)
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
Number of cases of TIBOLA
Time frame: baseline
6 secondary outcomes
Epidemiological and demographic characteristics
Time frame: baseline
Characteristics of tick bites
Time frame: baseline
Frequency of the various symptoms and clinical signs of the disease
Time frame: baseline
Biological results
Time frame: baseline
Treatment
Time frame: baseline
Entomological analysis
Time frame: evolution between 2016 and 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 41137175Kotzyba J, Baux E, Hansmann Y, Boyer P, Jaulhac B, Martinot M, Martha B, Kaeuffer C, Bonijoly T, Bani-Sadr F, Legoff A, Hoefler F, Blot M, Bourdellon L, Zilliox L, Boulanger N, Lefevre B. Tick-borne lymphadenopathy in northeastern France: a human and vector clinical-epidemiological study. Parasit Vectors. 2025 Oct 24;18(1):428. doi: 10.1186/s13071-025-07078-2.
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. This study is not recruiting at the moment.
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 TIBOLA and Rickettsia Infections, run by Central Hospital, Nancy, France at 2 sites in France.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of TIBOLA (time frame: baseline). 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 NCT05458245, which also lists 1 linked publication.
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 19 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.