Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria
NCT ID: NCT03231267
Last Updated: 2019-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
460 participants
OBSERVATIONAL
2018-02-12
2020-02-29
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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"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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admission in reanimation
* Duration of stay \> 72 h.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Dominique DECRE, Doctor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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réanimation médicale Hôpital Saint Antoine
Paris, , France
Countries
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References
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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.
Balcazar 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.
Other Identifiers
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NI16011
Identifier Type: -
Identifier Source: org_study_id
ID RCB 2016-A01787-44
Identifier Type: OTHER
Identifier Source: secondary_id
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