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Status unknownNCT05458245Updated Jul 19, 2022

TIBOLA : Multicenter Descriptive Study in Eastern France

An observational study in TIBOLA and Rickettsia Infections, sponsored by Central Hospital, Nancy, France. Status unknown at 2 sites in France. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Sex
All
01

Study 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).

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.

02

Conditions studied

  • TIBOLA
  • Rickettsia Infections

Keywords

  • dermacentor
  • DEBONEL
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

Inclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of cases of TIBOLA

    Time frame: baseline

Secondary outcomes

  1. Epidemiological and demographic characteristics

    gender, age, habitat, hobbies, occupation

    Time frame: baseline

  2. Characteristics of tick bites

    frequency, location, date

    Time frame: baseline

  3. Frequency of the various symptoms and clinical signs of the disease

    inoculation ulcer, alopecia, lymphadenopathy, asthenia, fever, rash, headache, arthromyalgia, pruritus, facial oedema, other

    Time frame: baseline

  4. Biological results

    serology and PCR of rickettsia, non-specific abnormalities

    Time frame: baseline

  5. Treatment

    nature, efficiency

    Time frame: baseline

  6. Entomological analysis

    respective proportion of Dermacentor and Ixodes encountered on the territory. Detection by molecular biology of the presence of Rickettsia spp. in ticks

    Time frame: evolution between 2016 and 2021

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05458245
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Elisabeth BAUX (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jul 14, 2022
Start date
Jun 1, 2022
Primary completion
Jan 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Jul 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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