Human Anaplasmosis in Eastern France

Tick-borne Disease Clinical Trial

Official title:

Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01013636
• Other study ID #: 3960
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2009
• Last updated: August 29, 2011
• Start date: November 2009

Study information

• Verified date: August 2011
• Source: University Hospital, Strasbourg, France
• Contact: Yves HANSMANN, MD
• Phone: 33.3.69.55.05.45
• Email: yves.hansmann[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite-

• Or

• patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities.

• Or

• patient with tick-borne encephalitis, or primary stage Lyme borreliosis

Exclusion Criteria:

• children less that 10 years

• pregnancy

• patients with an other diagnosis that can explain clinical symptoms or biological abnormalities

• antibiotherapy with cyclins during the days before inclusion

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaplasmosis
• Ehrlichia
• Tick-borne Disease
• Tick-Borne Diseases

Intervention

Procedure:
• Blood sampling
Anaplasma diagnosis test : serology and PCR If presence of Anaplasma infection, proposition of treatment with doxycylin 200 mg once-a-day during 10 days

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses et Tropicales - CHU de Besançon	Besançon
France	Centre Hospitalier de Colmar	Colmar
France	Département d'Infectiologie CHU de Dijon	Dijon
France	Centre Hospitalier de Guebwiller	Guebwiller
France	Centre Hospitalier de Haguenau	Haguenau
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Service des Maladies Infectieuses et Tropicales - CHU de Nancy	Nancy
France	Service de Médecine Interne et Maladies Infectieuses - CHU de Reims	Reims
France	Centre Hospitalier de Saverne	Saverne
France	Centre Hospitalier de Sélestat	Sélestat
France	Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Centre hospitalier de Wissembourg	Wissembourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion		6 weeks	No