AnaplasmosisNCT01013636
Human Anaplasmosis in Eastern France
An observational study of Anaplasmosis and Tick-borne Disease, run by University Hospital, Strasbourg, France at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Anaplasmosis, Tick-borne Disease, Ehrlichia
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 12 sitesFrance
- Study dates
- Nov 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with Anaplasma phagocytophilia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Besançon
Besançon
BRUNO HOEN, MD, 33.3.81.21.85.33, Bruno.hoen@univ-fcomte.fr
BRUNO HOEN, MD
- Recruiting
Centre Hospitalier de Colmar
Colmar
MARTIN MARTINOT, MD, 33.3.89.12.41.23, martin.martinot@ch-colmar.rss.fr
MARTIN MARTINOT, MD
- Not yet recruiting
Département d'Infectiologie CHU de Dijon
Dijon
LIONEL PIROTH, MD, 33.3.80.29.33.05, Lionel.piroth@chu-dijon.fr
LIONEL PIROTH, MD
- Recruiting
Centre Hospitalier de Guebwiller
Guebwiller
GENEVIEVE BOESS, MD, 33.3.89.74.78.00, genevieve.boess@ch-guebwiller.fr
GENEVIEVE BOESS, MD
- Recruiting
Centre Hospitalier de Haguenau
Haguenau
BERNARD WILLEMIN, MD, 33.3.88.06.33.33, bernard.willemin@ch-haguenau.fr
BERNARD WILLEMIN, MD
- Recruiting
Centre Hospitalier de Mulhouse
Mulhouse
JOY MOOTIEN, MD, 33.3.89.64.86.87, mootieny@ch-mulhouse.fr
JOY MOOTIEN, MD
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Nancy
Nancy
CHRISTIAN RABAUD, MD, 33.3.83.15.40.97, c.Rabaud@chu-nancy.fr
CHRISTIAN RABAUD, MD
- Recruiting
Service de Médecine Interne et Maladies Infectieuses - CHU de Reims
Reims
CHRISTOPHE STRADY, MD, 33.3.26.78.78.94, cstrasdy@chu-reims.fr
CHRISTOPHE STRADY, MD
- Recruiting
Centre Hospitalier de Saverne
Saverne
ELISABETH WURTZ, MD, 33.3.88.71.67.67, elisabeth.wurtz@ch-saverne.fr
ELISABETH WURTZ, MD
- Recruiting
Centre Hospitalier de Sélestat
Sélestat
FRANCOIS SAGEZ, MD, 33.3.88.57.55.55, francois.sagez@ch-selestat.fr
FRANCOIS SAGEZ, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
YVES HANSMANN, MD, 33.3.69.55.05.45, yves.hansmann@chru-strasbourg.fr
YVES HANSMANN, MD
- Recruiting
Centre hospitalier de Wissembourg
Wissembourg
ANDRE MICHEL, MD, 33.3.88.54.11.11, amichel@ch-wissembourg.fr
ANDRE MICHEL, MD
About this study
Official title: 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.
- Conditions
- Anaplasmosis, Tick-borne Disease, Ehrlichia
- Being tested
- Blood sampling
- Medical subject headings
- Anaplasmosis, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
- 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 group | Role | What they receive |
|---|---|---|
| Anaplasma | Not described Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaplasmosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- YVES HANSMANN, MD, Principal investigator, Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013636
- Sponsor's protocol ID
- 3960
- Status last verified
- Aug 2011
- First submitted
- 10 Nov 2009
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France
- ClinicalTrials.gov ID
- NCT01013636
- Acronym / sponsor ID
- 3960
- Conditions
- Anaplasmosis, Tick-borne Disease, Ehrlichia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2012 (estimated)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaplasma | – | Procedure: Blood sampling |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with Anaplasma phagocytophilia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Anaplasma |
Primary outcome
Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YVES HANSMANN, MD principal investigator
Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaplasmosis and Tick-borne Disease, run by University Hospital, Strasbourg, France at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves HANSMANN, MD (33.3.69.55.05.45, yves.hansmann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factor, clinical and biological markers of infection for patients with Anaplasma antibody seroconversion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.