Achromobacter Xylosoxidans (ACHX) Infections (ACHX)

July 22, 2019 updated by: University Hospital Center of Martinique

Achromobacter Xylosoxidans Infections : Epidemiology and Environmental Investigations

Data extraction from bacteriological laboratory of Martinique University hospital to determine the frequency and the distribution of nosocomial infections due to Achromobacter xylosoxidans (ACHX), an emerging multi-resistant environmental bacteria. The specific tropical environment and climatic conditions in Martinique may favor ACHX development and the investigators suppose that this new opportunistic pathogen can represent a danger for hospitalized patients. The aim of our study is to describe the most affected population and try to identify the main environmental sources of contamination.

Study Overview

Status

Status

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

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.

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

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 (Actual)

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.
120

Contacts and Locations

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

Study Locations

  • Martinique
      • Fort-de-France, Martinique, 97261
        • CHU de Martinique

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized

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

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

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 Center of Martinique

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: Karine SANCHEZ, Pharma D, Martinique University Hospital

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 (Actual)

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.
October 1, 2016

Primary Completion (Actual)

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.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

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).
December 7, 2017

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.
February 9, 2018

First Posted (Actual)

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.
February 12, 2018

Study Record Updates

Last Update Posted (Actual)

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.
July 24, 2019

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.
July 22, 2019

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.
February 1, 2018

More Information

Terms related to this study

Keywords

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.
  • 16/E/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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