Clinical trial NCT01013636: Human Anaplasmosis in Eastern France
Official title: Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anaplasmosis
Tick-borne Disease
Ehrlichia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Anaplasma phagocytophilia

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Besançon
city: Colmar
country: France
facility: Centre Hospitalier de Colmar
city: Dijon
country: France
facility: Département d'Infectiologie CHU de Dijon
city: Guebwiller
country: France
facility: Centre Hospitalier de Guebwiller
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Nancy
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Nancy
city: Reims
country: France
facility: Service de Médecine Interne et Maladies Infectieuses - CHU de Reims
city: Saverne
country: France
facility: Centre Hospitalier de Saverne
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
city: Sélestat
country: France
facility: Centre Hospitalier de Sélestat
city: Wissembourg
country: France
facility: Centre hospitalier de Wissembourg
Study officials:
affiliation: Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
name: YVES HANSMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: