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Human Anaplasmosis in Eastern France

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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

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   (Child, Adult, Senior)
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

Locations
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
Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Centre Hospitalier de Sélestat
Sélestat, France
Centre hospitalier de Wissembourg
Wissembourg, France
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

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 December 09, 2016