Multiresistant EnterobacteriaceaePHAGO-BMRNCT03231267
Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria
An observational study of Multiresistant Enterobacteriaceae, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This research focuses on antibiotic resistant bacteria that may reside in the digestive tract (intestinal flora) of everyone. When we develop an infection, the bacteria in question is, often, already present in our flora. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiresistant Enterobacteriaceae
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2018to Feb 2020
- 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 : adults admitted in intensive care for a period > 72h
Who may be able to join
- Age ≥ 18 years old
- Admission in reanimation
- Duration of stay > 72 h.
Who cannot join
- Absence of at least 2 consecutive faeces.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria: PHAGO- BMR
This research focuses on antibiotic resistant bacteria that may reside in the digestive tract (intestinal flora) of everyone.
When we develop an infection, the bacteria in question is, often, already present in our flora. Face to the growing phenomenon of multi-resistance, which is a public health problem, it is essential to follow the frequency of these bacteria but also to find new strategies and effective means to fight against their spread.
Read more
It has been discovered long time ago that it exists viruses able of destroying bacteria: they have been called bacteriophages .They was used before the arrival of antibiotics for the treatment of various infections (phagotherapy). Today, with the problems of resistance, phagotherapy could become a good way to fight against infections with bacteria very resistant but also a way to remove the resistant bacteria that are present in our digestive flora.
Moreover, it is known that these viruses of bacteria are present everywhere in the environment (waters, soils, human digestive tract and animal), it is important to check their presence in our digestive tract. Our objective is to study if the presence of these phages prevents resistant bacteria from set up in our digestive flora.
To answer the question, it is planned to include 460 people hospitalized in intensive care unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of resistant bacteria is carried out regularly during the hospitalization. Three resuscitation services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool samples collected at different times of the stay (admission and then during the stay), we will look for 2 types of bacteria and viruses capable of destroying them.
Read the detailed description
Evaluate the association between the presence of phage (s) in patients not carrying E. coli or K. pneumoniae ESBL or carbapenemase (EPC) (Ec-ESBL / EPC or Kp-ESBL / EPC) and subsequent acquisition Of carrying Ec-BLSE / EPC or Kp-BLSE / EPC during their stay in intensive care.
Collection of stools of the patients included at the admission then in a successive way. On the first stool, search for multiresistant bacteria. If positive research: search for bacteriophage directed against the strain of the patient bearing. Continued screening of stools from non-carriers at baseline.
In patients defined as non-carriers at the end of the inclusions and collection, selection of 8 stools for the detection of bacteriophages directed against all BMR strains which were isolated during the study period.
- Conditions
- Multiresistant Enterobacteriaceae
- Keywords
- Multiresistant enterobacteriaceae, digestive colonization, bacteriophages, Admission in intensive care unit >72h, Presence of at least 2 consecutive stools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "Carrier"of Ec-BLSE/EPC or Kp-BLSE/EPC | During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC | |
| Non-Carrier of Ec-BLSE/EPC orKp-BLSE/EPC | During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of phages capable of lysing circulating Ec-ESBL / EPC or Kp-ESBE / EPC in resuscitation units in non-carriers having acquired carriers E. coli or K. pneumoniae producing ESBL or carbapenemases .
The classification of patients in the Carrier / Non-carrier group is based on analysis of 2 consecutive faecal samples: at least one positive sample is required to consider the patient as "carrier" of Ec-ESBL / EPC or Kp-ESBL / EPC ; It necessary to have at least 2 negative excrement to consider the patient "non-carrier. " The rate of acquisition of Ec-ESBL / EPC or Kp-ESBL / EPC will be evaluated in non-carrier patients monitored during the study.
Measured: Through study completion. An average of 1 year after the study completion.
Secondary outcomes (1)
Presence or absence of phages in patients identified as carriers of Ec-ESBL / EPC or Kp-ESBL / EPC at entry to resuscitation (control population).
Characterization of isolated phages: number and specificity (lysis capacity of one or more strains of Ec-ESBL / EPC or Kp-ESBL / EPC evaluated by the percentage of patients carrying the Ec-ESBL / EPC or Kp-ESBL / EPC ).
Measured: Through study completion. An average of 1 year after the study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start12 Feb 2018
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiresistant EnterobacteriaceaeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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-control
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique DECRE, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231267
- Sponsor's protocol ID
- NI16011
- Other IDs
- ID RCB 2016-A01787-44
- Acronym
- PHAGO-BMR
- Status last verified
- Jul 2019
- First submitted
- 2 May 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adhya S, Merril CR, Biswas B. Therapeutic and prophylactic applications of bacteriophage components in modern medicine. Cold Spring Harb Perspect Med. 2014 Jan 1;4(1):a012518. doi: 10.1101/cshperspect.a012518.
PubMed 24384811Balcazar JL. Bacteriophages as vehicles for antibiotic resistance genes in the environment. PLoS Pathog. 2014 Jul 31;10(7):e1004219. doi: 10.1371/journal.ppat.1004219. eCollection 2014 Jul. No abstract available.
PubMed 25078987
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria: PHAGO- BMR
- ClinicalTrials.gov ID
- NCT03231267
- Acronym / sponsor ID
- PHAGO-BMR / NI16011
- Conditions
- Multiresistant Enterobacteriaceae
- Keywords
- Multiresistant enterobacteriaceae, digestive colonization, bacteriophages, Admission in intensive care unit >72h, Presence of at least 2 consecutive stools
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 27 Jul 2017 (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.
This research focuses on antibiotic resistant bacteria that may reside in the digestive tract (intestinal flora) of everyone.
When we develop an infection, the bacteria in question is, often, already present in our flora. Face to the growing phenomenon of multi-resistance, which is a public health problem, it is essential to follow the frequency of these bacteria but also to find new strategies and effective means to fight against their spread.
It has been discovered long time ago that it exists viruses able of destroying bacteria: they have been called bacteriophages .They was used before the arrival of antibiotics for the treatment of various infections (phagotherapy). Today, with the problems of resistance, phagotherapy could become a good way to fight against infections with bacteria very resistant but also a way to remove the resistant bacteria that are present in our digestive flora.
Moreover, it is known that these viruses of bacteria are present everywhere in the environment (waters, soils, human digestive tract and animal), it is important to check their presence in our digestive tract. Our objective is to study if the presence of these phages prevents resistant bacteria from set up in our digestive flora.
To answer the question, it is planned to include 460 people hospitalized in intensive care unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of resistant bacteria is carried out regularly during the hospitalization. Three resuscitation services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool samples collected at different times of the stay (admission and then during the stay), we will look for 2 types of bacteria and viruses capable of destroying them.
Detailed description
Evaluate the association between the presence of phage (s) in patients not carrying E. coli or K. pneumoniae ESBL or carbapenemase (EPC) (Ec-ESBL / EPC or Kp-ESBL / EPC) and subsequent acquisition Of carrying Ec-BLSE / EPC or Kp-BLSE / EPC during their stay in intensive care.
Collection of stools of the patients included at the admission then in a successive way. On the first stool, search for multiresistant bacteria. If positive research: search for bacteriophage directed against the strain of the patient bearing. Continued screening of stools from non-carriers at baseline.
In patients defined as non-carriers at the end of the inclusions and collection, selection of 8 stools for the detection of bacteriophages directed against all BMR strains which were isolated during the study period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Carrier"of Ec-BLSE/EPC or Kp-BLSE/EPC | – | –During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC |
| Non-Carrier of Ec-BLSE/EPC orKp-BLSE/EPC | – | –During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients : adults admitted in intensive care for a period > 72h
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Admission in reanimation
- Duration of stay > 72 h.
Key exclusion criteria (1 listed)
- Absence of at least 2 consecutive faeces.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of phages capable of lysing circulating Ec-ESBL / EPC or Kp-ESBE / EPC in resuscitation units in non-carriers having acquired carriers E. coli or K. pneumoniae producing ESBL or carbapenemases .
Time frame: Through study completion. An average of 1 year after the study completion.
The classification of patients in the Carrier / Non-carrier group is based on analysis of 2 consecutive faecal samples: at least one positive sample is required to consider the patient as "carrier" of Ec-ESBL / EPC or Kp-ESBL / EPC ; It necessary to have at least 2 negative excrement to consider the patient "non-carrier. " The rate of acquisition of Ec-ESBL / EPC or Kp-ESBL / EPC will be evaluated in non-carrier patients monitored during the study.
1 secondary outcome
Presence or absence of phages in patients identified as carriers of Ec-ESBL / EPC or Kp-ESBL / EPC at entry to resuscitation (control population).
Time frame: Through study completion. An average of 1 year after the study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 24384811Adhya S, Merril CR, Biswas B. Therapeutic and prophylactic applications of bacteriophage components in modern medicine. Cold Spring Harb Perspect Med. 2014 Jan 1;4(1):a012518. doi: 10.1101/cshperspect.a012518.
- Background: PubMed 25078987Balcazar JL. Bacteriophages as vehicles for antibiotic resistance genes in the environment. PLoS Pathog. 2014 Jul 31;10(7):e1004219. doi: 10.1371/journal.ppat.1004219. eCollection 2014 Jul. No abstract available.
- Individual participant dataSharing planned: Undecided
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.
Dominique DECRE, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
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 Multiresistant Enterobacteriaceae, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 3 inclusion and 1 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 16 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 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?
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?
Presence or absence of phages capable of lysing circulating Ec-ESBL / EPC or Kp-ESBE / EPC in resuscitation units in non-carriers having acquired carriers E. coli or K. pneumoniae producing ESBL or carbapenemases . (time frame: Through study completion. An average of 1 year after the study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231267, which also lists 2 linked publications.
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 16 Jul 2019.