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Human Anaplasmosis in Eastern France

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01013636
First received: November 10, 2009
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Anaplasmosis
Tick-borne Disease
Ehrlichia
Procedure: Blood sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anaplasma 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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with Anaplasma phagocytophilia

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013636

Contacts
Contact: Yves HANSMANN, MD 33.3.69.55.05.45 yves.hansmann@chru-strasbourg.fr

Locations
France
Service des Maladies Infectieuses et Tropicales - CHU de Besançon Not yet recruiting
Besançon, France
Contact: BRUNO HOEN, MD    33.3.81.21.85.33    Bruno.hoen@univ-fcomte.fr   
Principal Investigator: BRUNO HOEN, MD         
Centre Hospitalier de Colmar Recruiting
Colmar, France
Contact: MARTIN MARTINOT, MD    33.3.89.12.41.23    martin.martinot@ch-colmar.rss.fr   
Principal Investigator: MARTIN MARTINOT, MD         
Sub-Investigator: MAHSA MOHSENI, MD         
Département d'Infectiologie CHU de Dijon Not yet recruiting
Dijon, France
Contact: LIONEL PIROTH, MD    33.3.80.29.33.05    Lionel.piroth@chu-dijon.fr   
Principal Investigator: LIONEL PIROTH, MD         
Centre Hospitalier de Guebwiller Recruiting
Guebwiller, France
Contact: GENEVIEVE BOESS, MD    33.3.89.74.78.00    genevieve.boess@ch-guebwiller.fr   
Principal Investigator: GENEVIEVE BOESS, MD         
Centre Hospitalier de Haguenau Recruiting
Haguenau, France
Contact: BERNARD WILLEMIN, MD    33.3.88.06.33.33    bernard.willemin@ch-haguenau.fr   
Principal Investigator: BERNARD WILLEMIN, MD         
Sub-Investigator: REGIS DUKIC, MD         
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France
Contact: JOY MOOTIEN, MD    33.3.89.64.86.87    mootieny@ch-mulhouse.fr   
Principal Investigator: JOY MOOTIEN, MD         
Sub-Investigator: PIERRE KIEFFER, MD         
Service des Maladies Infectieuses et Tropicales - CHU de Nancy Not yet recruiting
Nancy, France
Contact: CHRISTIAN RABAUD, MD    33.3.83.15.40.97    c.Rabaud@chu-nancy.fr   
Principal Investigator: CHRISTIAN RABAUD, MD         
Service de Médecine Interne et Maladies Infectieuses - CHU de Reims Recruiting
Reims, France
Contact: CHRISTOPHE STRADY, MD    33.3.26.78.78.94    cstrasdy@chu-reims.fr   
Principal Investigator: CHRISTOPHE STRADY, MD         
Centre Hospitalier de Saverne Recruiting
Saverne, France
Contact: ELISABETH WURTZ, MD    33.3.88.71.67.67    elisabeth.wurtz@ch-saverne.fr   
Principal Investigator: ELISABETH WURTZ, MD         
Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: YVES HANSMANN, MD    33.3.69.55.05.45    yves.hansmann@chru-strasbourg.fr   
Principal Investigator: YVES HANSMANN, MD         
Sub-Investigator: GUILLAUME CAMUSET, MD         
Sub-Investigator: NICOLAS LEFEBVRE, MD         
Sub-Investigator: DANIEL CHRISTMANN, MD         
Sub-Investigator: Benoît JAULHAC, MD         
Sub-Investigator: Sylvie DE MARTINO, MD         
Centre Hospitalier de Sélestat Recruiting
Sélestat, France
Contact: FRANCOIS SAGEZ, MD    33.3.88.57.55.55    francois.sagez@ch-selestat.fr   
Principal Investigator: FRANCOIS SAGEZ, MD         
Centre hospitalier de Wissembourg Recruiting
Wissembourg, France
Contact: ANDRE MICHEL, MD    33.3.88.54.11.11    amichel@ch-wissembourg.fr   
Principal Investigator: ANDRE MICHEL, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: YVES HANSMANN, MD Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Christine GEILLER/ Directeur de la recherche clinique et des innovations, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01013636     History of Changes
Other Study ID Numbers: 3960
Study First Received: November 10, 2009
Last Updated: August 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anaplasmosis
Tick-Borne Diseases
Anaplasmataceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Arbovirus Infections
Virus Diseases
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014