Urinary InfectionPhase 4CARBEPARGNENCT02265445
Deescalating Carbapenems in Hospital Setting
A Phase 4 study testing Deescalation therapy and Maintaining carbapenem therapy in people with Urinary Infection and Digestive Infection, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Infection, Digestive Infection, Biliary Infection
- What is being tested?
- Deescalation therapy and Maintaining carbapenem therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Age ≥ 18 years
- Hospitalization in conventional ward; (3) Receiving a curative treatment with a carbapenem for at least 24 hours and less than 3 days for a recent infection due to an ESBL-PE, either initially or secondary documented
- With a site of infection originating from the urinary, digestive or biliary tract
- Identification of an ESBL-PE for which susceptibility results (by the method of discs) have shown to be susceptible to more narrow spectrum beta-lactams (cephalosporins, b-lactamase inhibitors, monobactams)
- With sepsis signs and symptoms controlled after initiation of antibiotic therapy
- For a community-acquired or hospital-acquired infection.
Who cannot join
- Pregnancy or breastfeeding
- Neutropenia (PNN < 500/mm3)
- Hospitalization in intensive care unit or bone marrow transplant unit
- Documented polymicrobial infection
- Culture of an ESBL-PE susceptible to an orally active drug (such as fluoroquinolones, cotrimoxazole) and possible use of one of these drugs
- Need to treat a EBLSE infection(s) wtih more than drug other than carbapenems
Show all 13Show fewer
- Need to maintain an association with an aminoglycoside
- Colonization without signs and symptoms of sepsis
- Sepsis signs and symptoms not controlled at the time of enrolment
- Known allergy to beta-lactams
- Failure to complete medical examination
- Absence of signed written consent.
- Patient without healthcare insurance (French social security, CMU or AME)
About this study
Official title: Deescalating Carbapenems in Hospital Setting: a Multicentre Randomized Controlled Study Comparing Carbapenem Continuation and Switch to Another Beta-lactam for the Treatment of Infections Due to ESBL-producing Enterobacteriaceae
The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections).
Read the detailed description
Carbapenems are considered the antibiotics of choice for the treatment of infections due to expanded-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-PE). Their use is readily increasing because of the pandemic of ESBL-PE. However, the future of these drugs is challenged by the worldwide emergency of new resistance mechanisms in the same pathogens, particularly the carbapenemases. This resistance makes these drugs inactive and gives no therapeutic options for patients. Resistance to carbapenems is strongly associated with the use of these drugs, because of their large spectrum and strong impact on the host flora. Consequently, the correct use of these drugs is an important public health objective. In France, the CA-SFM (Committee on Antimicrobial of the French Society for Microbiology) has suggested alternative strategies with narrow spectrum beta-lactam for the treatment of ESBL-PE infections, including 3rd or 4th cephalosporins, cefoxitin and penicillins with beta-lactamase inhibitors. A recent analysis including 6 prospective cohort studies of bloodstream infections due to ESBL-producing Escherichia coli did not find an excess of mortality or a longer length of hospital stay for patients receiving penicillin with beta-lactamase inhibitors, as compared to patients treated with carbapenems, after adjusting by confounding factors. As patients receiving carbapenems seem to be more severely affected, the efficacy and safety of the alternative strategy remain unproved. A randomized study is therefore needed to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections). The objectives of the present study are to demonstrate that the alternative strategy of deescalating therapy is not inferior to a strategy maintaining the carbapenem in terms of clinical cure, survival, lack of relapse and microbiological cure.
- Conditions
- Urinary Infection, Digestive Infection, Biliary Infection, Expanded-spectrum Beta-lactamase Producing ESBL
- Being tested
- Deescalation therapy, Maintaining carbapenem therapy
- Keywords
- Carbapenems therapy/ESBL infections/Deescalation, due to ESBL-PE
- Medical subject headings
- Urinary Tract Infections, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deescalation therapyDrug
Also called Switch for a narrow spectrum beta-lactam active
Intravenous therapy Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE.
Maintaining carbapenem therapyDrug
Intravenous therapy, Maintaining carbapenem therapy
| Study group | Role | What they receive |
|---|---|---|
| Maintaining carbapenem therapy | Active comparator | Intravenous therapy, Maintaining carbapenem therapy Receives: Drug: Maintaining carbapenem therapy |
| Deescalation therapy | Active comparator | Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE. Deescalation therapy Receives: Drug: Deescalation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The main outcome will be the favorable response defined by criteria adapted to site of infection including clinical cure with resolution of sepsis, survival, microbiological eradication either documented or suspected, and the absence of a new antibiotic course for the treatment of the same ESBL-PE) at day 7 after the end of therapy.
Measured: 7 days after the end of therapy
Secondary outcomes (2)
Vital status of patients
Vital status at day 60 after initiation therapy ; Relapse at day 60 following initiation of therapy
Measured: 60 days after the initiation of therapy
absence of relapse of the infection due to the same ESBL-PE strain
Vital status at day 60 after initiation therapy ; Relapse at day 60 following initiation of therapy
Measured: 60 days after the initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: The study was stopped for recruitment defect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillipe LESPRIT, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265445
- Sponsor's protocol ID
- P130949
- Other IDs
- AOM 13063
- Acronym
- CARBEPARGNE
- Status last verified
- Feb 2017
- First submitted
- 2 Oct 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deescalating Carbapenems in Hospital Setting: a Multicentre Randomized Controlled Study Comparing Carbapenem Continuation and Switch to Another Beta-lactam for the Treatment of Infections Due to ESBL-producing Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT02265445
- Acronym / sponsor ID
- CARBEPARGNE / P130949
- Conditions
- Urinary Infection, Digestive Infection, Biliary Infection, Expanded-spectrum Beta-lactamase Producing ESBL
- Keywords
- Carbapenems therapy/ESBL infections/Deescalation, due to ESBL-PE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped for recruitment defect
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections).
Detailed description
Carbapenems are considered the antibiotics of choice for the treatment of infections due to expanded-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-PE). Their use is readily increasing because of the pandemic of ESBL-PE. However, the future of these drugs is challenged by the worldwide emergency of new resistance mechanisms in the same pathogens, particularly the carbapenemases. This resistance makes these drugs inactive and gives no therapeutic options for patients. Resistance to carbapenems is strongly associated with the use of these drugs, because of their large spectrum and strong impact on the host flora. Consequently, the correct use of these drugs is an important public health objective. In France, the CA-SFM (Committee on Antimicrobial of the French Society for Microbiology) has suggested alternative strategies with narrow spectrum beta-lactam for the treatment of ESBL-PE infections, including 3rd or 4th cephalosporins, cefoxitin and penicillins with beta-lactamase inhibitors. A recent analysis including 6 prospective cohort studies of bloodstream infections due to ESBL-producing Escherichia coli did not find an excess of mortality or a longer length of hospital stay for patients receiving penicillin with beta-lactamase inhibitors, as compared to patients treated with carbapenems, after adjusting by confounding factors. As patients receiving carbapenems seem to be more severely affected, the efficacy and safety of the alternative strategy remain unproved. A randomized study is therefore needed to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections). The objectives of the present study are to demonstrate that the alternative strategy of deescalating therapy is not inferior to a strategy maintaining the carbapenem in terms of clinical cure, survival, lack of relapse and microbiological cure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintaining carbapenem therapy | Active comparator | Drug: Maintaining carbapenem therapyIntravenous therapy, Maintaining carbapenem therapy |
| Deescalation therapy | Active comparator | Drug: Deescalation therapySwitch for a narrow spectrum beta-lactam active on the causative ESBL-PE. Deescalation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Hospitalization in conventional ward; (3) Receiving a curative treatment with a carbapenem for at least 24 hours and less than 3 days for a recent infection due to an ESBL-PE, either initially or secondary documented
- With a site of infection originating from the urinary, digestive or biliary tract
- Identification of an ESBL-PE for which susceptibility results (by the method of discs) have shown to be susceptible to more narrow spectrum beta-lactams (cephalosporins, b-lactamase inhibitors, monobactams)
- With sepsis signs and symptoms controlled after initiation of antibiotic therapy
Key exclusion criteria (13 listed)
- Pregnancy or breastfeeding
- Neutropenia (PNN < 500/mm3)
- Hospitalization in intensive care unit or bone marrow transplant unit
- Documented polymicrobial infection
- Culture of an ESBL-PE susceptible to an orally active drug (such as fluoroquinolones, cotrimoxazole) and possible use of one of these drugs
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 |
|---|---|---|
| Deescalation therapyAlso: Switch for a narrow spectrum beta-lactam activeIntravenous therapy Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE. | Drug | Deescalation therapy |
| Maintaining carbapenem therapyIntravenous therapy, Maintaining carbapenem therapy | Drug | Maintaining carbapenem therapy |
Primary outcome
Clinical response
Time frame: 7 days after the end of therapy
The main outcome will be the favorable response defined by criteria adapted to site of infection including clinical cure with resolution of sepsis, survival, microbiological eradication either documented or suspected, and the absence of a new antibiotic course for the treatment of the same ESBL-PE) at day 7 after the end of therapy.
2 secondary outcomes
Vital status of patients
Time frame: 60 days after the initiation of therapy
absence of relapse of the infection due to the same ESBL-PE strain
Time frame: 60 days after the initiation of therapy
Results and safety
The study was stopped early (reason given: The study was stopped for recruitment defect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Phillipe LESPRIT, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deescalation therapy and Maintaining carbapenem therapy in people with Urinary Infection and Digestive Infection, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped for recruitment defect). 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?
Clinical response (time frame: 7 days after the end of therapy). 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 23 Feb 2017.