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CompletedNCT03429283ACHXUpdated Jul 24, 2019

Achromobacter Xylosoxidans (ACHX) Infections

An observational study in Nosocomial Infection, sponsored by University Hospital Center of Martinique. Completed at 1 site in Martinique. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by University Hospital Center of Martinique · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Nosocomial Infection

Keywords

  • Epidemiology,
  • Achromobacter xylosoxidans,
  • antibiotic resistance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized

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

Exclusion Criteria:

  • Patient hospitalized in another site...
  • Patients hospitalized less than 48h before bacteriological analysis......
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
120 participants (actual)
Patient registry
No

Interventions

  • Otherdescriptive retrospective epidemiological study

    descriptive retrospective epidemiological study

05

What researchers measure

Primary outcomes

  1. The incidence rate of Achromobacter xylosoxidans nosocomial infections

    number of infections/ total number of patients hospitalized in our institution

    Time frame: january 2006 to december 2016

Secondary outcomes

  1. The incidence density of Achromobacter xylosoxidans nosocomial infections

    number of infections/ total number of days of hospitalization

    Time frame: january 2006 to december 2016

  2. Mortality rate related to ACHX,

    number of deaths at three months

    Time frame: january 2006 to december 2016

06

Study locations

1 site
  • CHU de Martinique
    Fort-de-France, 97261, Martinique
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03429283
Lead sponsor
University Hospital Center of Martinique
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Oct 2016
Primary completion
May 2017
Completion
Jun 2017
Last update
Jul 24, 2019

Study contacts

Karine SANCHEZ, Pharma D
principal investigator · Martinique University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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