TIBOLA : Multicenter Descriptive Study in Eastern France

Rickettsia Infections Clinical Trial

Official title:

TIBOLA : Multicenter Descriptive Study in Eastern France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458245
• Other study ID #: 2021PI121
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Rickettsia Infections

Locations

Country	Name	City	State
France	Yves Hansmann	Strasbourg
France	Elisabeth Baux	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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