NCT01013636

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

2.4 years

First QC Date

November 10, 2009

Last Update Submit

August 29, 2011

Conditions

AnaplasmosisTick-borne DiseaseEhrlichia

Outcome Measures

Primary Outcomes (1)

  • Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion

    6 weeks

Study Arms (1)

Anaplasma

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

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

Anaplasma

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Anaplasma phagocytophilia

You may qualify if:

  • 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-
  • patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities.
  • patient with tick-borne encephalitis, or primary stage Lyme borreliosis

You may not qualify if:

  • children less that 10 years
  • pregnancy
  • patients with an other diagnosis that can explain clinical symptoms or biological abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Service des Maladies Infectieuses et Tropicales - CHU de Besançon

Besançon, France

NOT YET RECRUITING

Centre Hospitalier de Colmar

Colmar, France

RECRUITING

Département d'Infectiologie CHU de Dijon

Dijon, France

NOT YET RECRUITING

Centre Hospitalier de Guebwiller

Guebwiller, France

RECRUITING

Centre Hospitalier de Haguenau

Haguenau, France

RECRUITING

Centre Hospitalier de Mulhouse

Mulhouse, France

RECRUITING

Service des Maladies Infectieuses et Tropicales - CHU de Nancy

Nancy, France

NOT YET RECRUITING

Service de Médecine Interne et Maladies Infectieuses - CHU de Reims

Reims, France

RECRUITING

Centre Hospitalier de Saverne

Saverne, France

RECRUITING

Centre Hospitalier de Sélestat

Sélestat, France

RECRUITING

Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Centre hospitalier de Wissembourg

Wissembourg, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

AnaplasmosisTick-Borne Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anaplasmataceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVector Borne DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • YVES HANSMANN, MD

    Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves HANSMANN, MD

CONTACT

33.3.69.55.05.45yves.hansmann@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 16, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

FR(12)