Human Anaplasmosis in Eastern France

August 29, 2011 updated by: University Hospital, Strasbourg, France

Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France
        • Not yet recruiting
        • Service des Maladies Infectieuses et Tropicales - CHU de Besançon
        • Contact:
        • Principal Investigator:
          • BRUNO HOEN, MD
      • Colmar, France
        • Recruiting
        • Centre Hospitalier de Colmar
        • Contact:
        • Principal Investigator:
          • Martin MARTINOT, MD
        • Sub-Investigator:
          • MAHSA MOHSENI, MD
      • Dijon, France
        • Not yet recruiting
        • Département d'Infectiologie CHU de Dijon
        • Contact:
      • Guebwiller, France
        • Recruiting
        • Centre Hospitalier de Guebwiller
        • Contact:
        • Principal Investigator:
          • GENEVIEVE BOESS, MD
      • Haguenau, France
        • Recruiting
        • Centre Hospitalier de Haguenau
        • Contact:
        • Principal Investigator:
          • BERNARD WILLEMIN, MD
        • Sub-Investigator:
          • REGIS DUKIC, MD
      • Mulhouse, France
        • Recruiting
        • Centre Hospitalier de Mulhouse
        • Contact:
        • Principal Investigator:
          • JOY MOOTIEN, MD
        • Sub-Investigator:
          • PIERRE KIEFFER, MD
      • Nancy, France
        • Not yet recruiting
        • Service des Maladies Infectieuses et Tropicales - CHU de Nancy
        • Contact:
        • Principal Investigator:
          • CHRISTIAN RABAUD, MD
      • Reims, France
        • Recruiting
        • Service de Médecine Interne et Maladies Infectieuses - CHU de Reims
        • Contact:
        • Principal Investigator:
          • CHRISTOPHE STRADY, MD
      • Saverne, France
        • Recruiting
        • Centre Hospitalier de Saverne
        • Contact:
        • Principal Investigator:
          • ELISABETH WURTZ, MD
      • Strasbourg, France, 67091
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Sub-Investigator:
          • GUILLAUME CAMUSET, MD
        • Sub-Investigator:
          • DANIEL CHRISTMANN, MD
        • Sub-Investigator:
          • Benoît JAULHAC, MD
        • Sub-Investigator:
          • Sylvie DE MARTINO, MD
      • Sélestat, France
        • Recruiting
        • Centre Hospitalier de Sélestat
        • Contact:
        • Principal Investigator:
          • FRANCOIS SAGEZ, MD
      • Wissembourg, France
        • Recruiting
        • Centre hospitalier de Wissembourg
        • Contact:
        • Principal Investigator:
          • ANDRE MICHEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with Anaplasma phagocytophilia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: YVES HANSMANN, MD, Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3960

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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