- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03429283
Achromobacter Xylosoxidans (ACHX) Infections (ACHX)
Achromobacter Xylosoxidans Infections : Epidemiology and Environmental Investigations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In June 2016, a patient who developed a Staphylococcus aureus mediastinitis died of a superinfection by Achromobacter xylosoxidans. This germ is an hydrotelluric bacteria described as emergent and multi-resistant, involved in nosocomial infections. It is known to be responsible for severe nosocomial infections in immunocompromised individuals (endocarditis, bacteriemia, wound infections, pneumonia) associated with high morbidity and mortality but it is also able to infect immunocompetent patients. According to literature, it is capable of developing in antiseptic and disinfectant solutions due to the acquisition of resistance to these products. Moreover it has a great ability to form biofilms, resulting in major eradication difficulties, both on the environmental and clinical level.
Various environmental sources of contamination have been identified, including dental units water lines, dialysis water, nebulizers, reusable boxes of disinfectant wipes, siphons of patient's rooms, vials of heparin...
There is no evidence for the existence of a possible portage in humans, but ACHX has already been isolated from the intestine of a 3-month-old baby who has never received antibiotic treatment. On the other hand, this germ colonizes the respiratory system of patients with cystic fibrosis. The frequency of isolation in sputum of these patients is increasing for a decade for still unknown reasons. ACHX surgical site infections are rare and to our knowledge only two cases of ACHX mediastinitis have been reported in the literature to date, either because cases are indeed rare or because the high mortality rate restricts publications. The clinical case of our CHU caught our attention and the investigators contacted the laboratory of bacteriology to inquire about the existence of other cases of infection with this germ. The investigators have then seen that ACHX seems to evolve in low noise for more than 10 years in our hospital with about 10 cases of infection per year.
Also, the investigators wanted to learn more and propose a study articulated around two axes:
- An epidemiological axis, in which the investigators detail local epidemiology, calculate rates of impact and analyze their evolution over 10 years, identify the most affected units, identify the types of most common infections, identify a population at risk, study profiles of resistance of the isolated strains,
- An environmental axis with identification of potential sources after development of appropriate analytical methods.
The ultimate goal of this study is the protection of patients by the fight against ACHX nosocomial infections and other related germs, by preventive eradication methods of environmental sources once they have been identified. The investigators want to avoid a new fatal infection episode.
A research of ACHX natural reservoirs in Martinique is also conceivable subsequently, the hypothesis being that this germ, particularly greedy of heat and humidity, is very present in a tropical environment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Fort-de-France, Martinique, 97261
- CHU de Martinique
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients hospitalized in Martinique University Hospital, Pierre Zobda Quitman site, from January 2006 to December 2016, with biological sample positive to ACHX
Exclusion Criteria:
- Patient hospitalized in another site…
- Patients hospitalized less than 48h before bacteriological analysis……
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence rate of Achromobacter xylosoxidans nosocomial infections
Time Frame: january 2006 to december 2016
|
number of infections/ total number of patients hospitalized in our institution
|
january 2006 to december 2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence density of Achromobacter xylosoxidans nosocomial infections
Time Frame: january 2006 to december 2016
|
number of infections/ total number of days of hospitalization
|
january 2006 to december 2016
|
|
Mortality rate related to ACHX,
Time Frame: january 2006 to december 2016
|
number of deaths at three months
|
january 2006 to december 2016
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karine SANCHEZ, Pharma D, Martinique University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/E/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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