Nosocomial InfectionACHXNCT03429283
Achromobacter Xylosoxidans (ACHX) Infections
An observational study of Nosocomial Infection, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- descriptive retrospective epidemiological study
- How many people
- 120 participants
- Where
- 1 siteMartinique
- Study dates
- Oct 2016to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized
Who may be able to join
- Patients hospitalized in Martinique University Hospital, Pierre Zobda Quitman site, from January 2006 to December 2016, with biological sample positive to ACHX
Who cannot join
- Patient hospitalized in another site…
- Patients hospitalized less than 48h before bacteriological analysis……
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Nosocomial Infection
- Being tested
- descriptive retrospective epidemiological study
- Keywords
- Epidemiology,, Achromobacter xylosoxidans,, antibiotic resistance
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptive retrospective epidemiological studyOther
descriptive retrospective epidemiological study
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of Achromobacter xylosoxidans nosocomial infections
number of infections/ total number of patients hospitalized in our institution
Measured: january 2006 to december 2016
Secondary outcomes (2)
The incidence density of Achromobacter xylosoxidans nosocomial infections
number of infections/ total number of days of hospitalization
Measured: january 2006 to december 2016
Mortality rate related to ACHX,
number of deaths at three months
Measured: january 2006 to december 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study startOct 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine SANCHEZ, Pharma D, Principal investigator, Martinique University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429283
- Sponsor's protocol ID
- 16/E/19
- Acronym
- ACHX
- Status last verified
- Feb 2018
- First submitted
- 7 Dec 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achromobacter Xylosoxidans Infections : Epidemiology and Environmental Investigations
- ClinicalTrials.gov ID
- NCT03429283
- Acronym / sponsor ID
- ACHX / 16/E/19
- Conditions
- Nosocomial Infection
- Keywords
- Epidemiology,, Achromobacter xylosoxidans,, antibiotic resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized
Key inclusion criteria (1 listed)
- Patients hospitalized in Martinique University Hospital, Pierre Zobda Quitman site, from January 2006 to December 2016, with biological sample positive to ACHX
Key exclusion criteria (2 listed)
- Patient hospitalized in another site…
- Patients hospitalized less than 48h before bacteriological analysis……
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 |
|---|---|---|
| descriptive retrospective epidemiological studydescriptive retrospective epidemiological study | Other | – |
Primary outcome
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
2 secondary outcomes
The incidence density of Achromobacter xylosoxidans nosocomial infections
Time frame: january 2006 to december 2016
Mortality rate related to ACHX,
Time frame: january 2006 to december 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Karine SANCHEZ, Pharma D principal investigator
Martinique University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Infection, run by University Hospital Center of Martinique at 1 site in Martinique.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of Achromobacter xylosoxidans nosocomial infections (time frame: january 2006 to december 2016). 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 24 Jul 2019.