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Human Anaplasmosis in Eastern France

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ClinicalTrials.gov Identifier: NCT01013636
Recruitment Status : Unknown
Verified August 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : November 16, 2009
Last Update Posted : August 30, 2011
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date November 10, 2009
First Posted Date November 16, 2009
Last Update Posted Date August 30, 2011
Study Start Date November 2009
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2009)
Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion [ Time Frame: 6 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Human Anaplasmosis in Eastern France
Official Title Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population patients with Anaplasma phagocytophilia
Condition
  • Anaplasmosis
  • Tick-borne Disease
  • Ehrlichia
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
Study Groups/Cohorts Anaplasma
Intervention: Procedure: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 13, 2009)
300
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01013636
Other Study ID Numbers 3960
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christine GEILLER/ Directeur de la recherche clinique et des innovations, University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Principal Investigator: YVES HANSMANN, MD Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date August 2011