Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient? (CORPOBLSE2)
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| ClinicalTrials.gov Identifier: NCT04699981 |
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Recruitment Status :
Recruiting
First Posted : January 7, 2021
Last Update Posted : April 27, 2021
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Among Enterobacteriaceae, the production of beta-lactamases (ESBLs) is the leading cause of multi-resistance. The first cases of ESBL-producing Enterobacteriaceae (E-ESBL) infections were described in the 1980s and subsequently experienced worldwide dissemination.
Since the turn of the century, the prevalence of E-ESBL infections, especially among Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae) has increased dramatically.
The emergence of multidrug-resistant Enterobacteriaceae is currently a real public health problem. The European Antimicrobial Resistance Surveillance Network evaluated, among clinical strains, the rate of resistance to 3rd generation cephalosporins (C3G) at 9.5% for E. coli and 28% for K. pneumoniae. Numerous studies have shown that bacterial colonization is the prerequisite for the occurrence of many infections.
However, the existence of prior colonization does not seem to be the only risk factor for the occurrence of a secondary infection. Therefore, in patients with multidrug-resistant Gram-negative bacillus gastrointestinal carriage there appear to be factors associated with the onset of infection. Several studies have examined the risk factors associated with E-ESBL-related infections in both community-based and healthcare-associated / nosocomial infections. Two main risk factors seem to be associated with E-ESBL infections: prior antibiotic therapy and the existence of invasive devices.
A recent study, carried out on 1288 patients and aimed at validating a predictive score for the occurrence of ESBL-E bacteremia, demonstrated 5 factors associated with the appearance of E-ESBL-linked bacteremia. These factors were: (i) a history of colonization / infection with ESBL-E, (ii) age ≥ 43 years, (iii) recent hospitalization in a region with a high prevalence of ESBL-E, (iv) antibiotic therapy ≥ 6 days in the previous 6 months and (v) the existence of a chronic vascular access.
Recently, a retrospective case-control study conducted in the United States by Augustine et al. Suggested that 5% of cases of bacteremia were related to ESBL-E.
Few studies have looked at risk factors for infection in patients known to be colonized by the digestive system. In a retrospective case-control study, conducted outside the intensive care unit and including pediatric and adult patients, the authors identified 2 factors associated with the occurrence of Ec-ESBL infection in previously colonized patients. These two factors were the prior use of antibiotics with β-lactam antibiotics and β-lactamase inhibitor (s), and urinary catheterization.
In intensive care hospital patients, the occurrence of ESBL-producing enterobacteriaceae infection appears to be a rare event, including in colonized patients.
The work of Ruppé et al. showed a direct link between relative fecal abundance of EScher-producing Escherichia coli and prior antibiotic intake.
This work also demonstrated a link between the value of the relative fecal abundance in Ec-ESBL and the occurrence of a urinary tract infection linked to the same clone. In particular, the authors found that women with a low relative fecal abundance rate (≤ 0.1%) had no risk of developing an Escherichia coli urinary tract infection. Conversely, the risk increased with the relative fecal abundance of Escherichia coli, but with a positive predictive value limited to 57% for relative fecal abundances between 10 and 100%.
| Condition or disease | Intervention/treatment | Phase |
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| Enterobacteria Infections | Other: Control (Patients colonized rectally with ESBL-producing enterobacteria without antibiotic pressure) Other: Case (Patients colonized rectally with ESBL-producing enterobacteriaceae, with antibiotic pressure) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient? |
| Actual Study Start Date : | March 17, 2021 |
| Estimated Primary Completion Date : | February 1, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Control: Patients colonized rectally with ESBL-producing enterobacteria without antibiotic pressure
Known patients colonized rectally with ESBL-producing enterobacteria and not subjected to antibiotic pressure
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Other: Control (Patients colonized rectally with ESBL-producing enterobacteria without antibiotic pressure)
For patients included in the "Control group" on discharge from hospitalization and 60 days after inclusion of patients, data will be collected either from the patient's medical file (T1Control) or during '' a telephone call from the patient (T2Control). The data collected concerns the occurrence of an infectious episode. They will also benefit from a stool sample at T1 control in order to assess the evolution kinetics of the relative fecal abundance of ESBL-producing enterobacteria in these patients who are not subjected to antibiotic pressure but subjected to other drug pressures (PPI, corticosteroids, etc.). |
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Experimental: Case: Patients colonized rectally with ESBL-producing enterobacteriaceae, with antibiotic pressure
Known patients colonized rectally with ESBL-producing enterobacteriaceae and subjected to antibiotic pressure (antibiotic therapy predicted greater than 24 hours) with beta-lactams or dual therapy comprising a beta-lactam. The prescription of antibiotic therapy, a decision independent of the study procedures, will be carried out as part of routine care in the context of microbiologically documented infection. The choice of molecules will be left to the discretion of clinicians.
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Other: Case (Patients colonized rectally with ESBL-producing enterobacteriaceae, with antibiotic pressure)
A stool culture is performed on the first stool emitted after the start of antibiotic therapy. 72 hours after the start of antibiotic therapy, a blood sample (5 ml) and a stool sample will be taken. A stool sample will be taken at the end of the antibiotic therapy and 60 days after the end of the antibiotic therapy. In the event of "normal" transit (daily bowel movements), the stool emitted 48 hours after the start of antibiotic therapy will be analyzed. If the patient does not pass stool, an eswab rectal swab will be taken. In the event of discharge from the hospital before the end of the antibiotic therapy and / or the D60 after the end of the antibiotic therapy, the patient will be given a prescription and an appointment at the collection center of the center concerned for the sample stool. |
- Percentage of EBLSE [ Time Frame: Day 60 ]This outcome corresponds to comparison of the relative fecal abundance (expressed as a percentage) of ESBL E and the microbiota in the 2 groups of patients.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patient (≥ 18 years old) hospitalized at the Paris Saint-Joseph Hospital Group or in the intensive care unit of Avicenne hospital, Necker Enfants Malades hospital, Center Sud Francilien, detected as a carrier of enterobacteriaceae in the digestive system ESBL producers
- Patient who had not had antibiotic treatment in the 3 weeks before inclusion
- Patient affiliated to a health insurance plan
- French-speaking patient
- Patient living at home, in EHPAD or retirement home
- Patient or Relative able to give free, informed and express consent
Exclusion Criteria:
- Known patient colonized rectally with ESBL-producing enterobacteria and subjected to antibiotic pressure other than beta-lactams
- Time to inclusion> 24 hours after initiation of antibiotic therapy
- Patient participating simultaneously in other intervention research that may interfere with the objectives of the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant or breastfeeding woman
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699981
| Contact: Benoit PILMIS, MD | 144127820 ext +33 | bpilmis@ghpsj.fr | |
| Contact: Helene BEAUSSIER, PharmD, pHD | 144127883 ext +33 | crc@ghpsj.fr |
| France | |
| Groupe Hospitalier Paris Saint-Joseph | Recruiting |
| Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014 | |
| Contact: Benoit PILMIS, MD 144127820 ext +33 bpilmis@ghpsj.fr | |
| Hôpital Necker-Enfants malades | Not yet recruiting |
| Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75015 | |
| Contact: Claire ROUZAUD, MD claire.rouzaud@aphp.fr | |
| Principal Investigator: Claire ROUZAUD, MD | |
| Hôpital Avicenne | Not yet recruiting |
| Bobigny, France, 93000 | |
| Contact: Jean-Ralph Zahar, MD jean-ralph.zahar@aphp.fr | |
| Principal Investigator: Jean-Ralph Zahar, MD | |
| Centre Hospitalier Sud-Francilien | Not yet recruiting |
| Corbeil-Essonnes, France, 91106 | |
| Contact: Didier LECOINTE, MD didier.lecointe@chsf.fr | |
| Principal Investigator: Didier LECOINTE, MD | |
| Principal Investigator: | Benoit PILMIS, MD | Groupe Hospitalier Paris Saint Joseph |
| Responsible Party: | Groupe Hospitalier Paris Saint Joseph |
| ClinicalTrials.gov Identifier: | NCT04699981 |
| Other Study ID Numbers: |
COPROBLSE2 |
| First Posted: | January 7, 2021 Key Record Dates |
| Last Update Posted: | April 27, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases Disease Attributes Pathologic Processes |
Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |