TIBOLA : Multicenter Descriptive Study in Eastern France

July 15, 2022 updated by: Elisabeth BAUX, Central Hospital, Nancy, France

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Elisabeth Baux
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cases of TIBOLA
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological and demographic characteristics
Time Frame: baseline
gender, age, habitat, hobbies, occupation
baseline
Characteristics of tick bites
Time Frame: baseline
frequency, location, date
baseline
Frequency of the various symptoms and clinical signs of the disease
Time Frame: baseline
inoculation ulcer, alopecia, lymphadenopathy, asthenia, fever, rash, headache, arthromyalgia, pruritus, facial oedema, other
baseline
Biological results
Time Frame: baseline
serology and PCR of rickettsia, non-specific abnormalities
baseline
Treatment
Time Frame: baseline
nature, efficiency
baseline
Entomological analysis
Time Frame: 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
evolution between 2016 and 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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