TIBOLA : Multicenter Descriptive Study in Eastern France

• Conditions: Rickettsia Infections; TIBOLA

• Registration Number: NCT05458245
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-01-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cases of TIBOLA	baseline

Secondary Outcome Measures

Name	Time	Method
Frequency of the various symptoms and clinical signs of the disease	baseline	inoculation ulcer, alopecia, lymphadenopathy, asthenia, fever, rash, headache, arthromyalgia, pruritus, facial oedema, other
Characteristics of tick bites	baseline	frequency, location, date
Entomological analysis	evolution between 2016 and 2021	respective proportion of Dermacentor and Ixodes encountered on the territory. Detection by molecular biology of the presence of Rickettsia spp. in ticks
Epidemiological and demographic characteristics	baseline	gender, age, habitat, hobbies, occupation
Biological results	baseline	serology and PCR of rickettsia, non-specific abnormalities
Treatment	baseline	nature, efficiency

Trial Locations

Locations (2)

Yves Hansmann; 🇫🇷 Strasbourg, France

Elisabeth Baux; 🇫🇷 Vandœuvre-lès-Nancy, France