Urinary Tract InfectionsPhase 4COLIFOXNCT02474706
Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli
A Phase 4 study testing Cefoxitin and imipenem in people with Urinary Tract Infections, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cefoxitin and imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Dec 2017
- 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
- Patient admitted to any medical or surgical department in the participating centre
- Documented urinary tract infection (other than cystitis), with or without bacteremia, caused by ESBL-producing E. coli susceptible in vitro to cefoxitin (minimal inhibition concentration <= 8 mg/L and /or diameter ≥ 19 mm according to CA-SFM 2015) and resistant to fluoroquinolones and to association trimethoprim-sulfamethoxazole. An E. Coli urinary tract infection is defined according to SPILF 2014 Clarification by a leucocytury ≥ 104/mL and clinical significant limit at 103 UFC/ml, for the men or the women.
- Medical examination prior to inclusion
- Informed consent signed by the patient
- Patient affiliated to a French Sécurité Social regimen
Who cannot join
- Serious infection (severe sepsis, septic shock)
- Pregnant or breast-feeding women
- Chronic kidney failure (creatinine clearance < 30 ml/min) and/or dialysis
- Hypersensibility to imipenem/cilastatine, to cefoxitine
- Hypersensibility to another antibiotics of cephalosporine class
- Hypersensibility to another antibiotics of carbapenem class
Show all 14Show fewer
- Severe hypersensibility (ex :anaphylactic reaction, or serious cutaneous reaction) to all other antibiotics from beta lactamines family (ex : penicillins, monobactam)
- Treatment with ganciclovir and/or valproic acid
- Infection on the urinary cathether
- Empirical antibiotic therapy including an aminoglycoside
- Patient being treated with antibiotic(s) for another infection
- Patient participating to another interventional study
- Patient not compliant according to the investigator's opinion
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development.
Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems.
Read more
The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field.
Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.
Secondary objectives:
- To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.
- To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.
Read the detailed description
Rationale:
Commensal enterobacteriaceae of the digestive tract, mostly represented by E.coli, can cause a wide range of infections such as urinary tract infections or severe bacteraemia. For several years now, the misuse of antibiotics and cross-transmission in hospitals have led to the emergence of Enterobacteriaceae producing extended-spectrum β-lactamases (ESBL). The rising prevalence of ESBL is estimated at 8.2% in healthcare settings and at 6.2% in the community.
Carbapenems are considered the reference treatment for ESBL-producing E.coli (EESBL) infections. They often remain the last effective treatment on an individual level. But on a larger scale, their increasing use contributes to the emergence of resistance that might soon become a major public health issue.
Although the prevalence of ESBL remains low, the rate of ESBL epidemics in French hospitals has increased hugely since 2004. This could become a cause of concern especially because very few antibacterial agents are currently in development.
So infectiologists and microbiologists have to consider alternatives to carbapenems to treat infections caused by EESBL, which is stipulated in the new recommendations from the French High Council for Public Health and the Infectious Disease Society of America.
Older and well-known molecules that have proved to be effective in-vitro against EESBL may be an option. However due to a lack of conclusive studies, they're still not recommended in these cases. Cefoxitin, a cephamycin antibiotic, may be a good alternative treatment for EESBL infections and contribute to spare the use of carbapenems.
Originality and innovation:
Previous studies of cephamycins have shown encouraging results, but they were mostly cohort trials with retrospective data or subsets of non-randomized studies. So a randomized prospective non-inferiority study comparing ertapenem and cefoxitine is necessary. If the results show non-inferiority of cefoxitine versus ertapenem, immediate clinical application should ensue and lead to new recommendations, highly anticipated by the infectiologists who support this project via their clinical research network.
Project feasibility:
The pace of inclusions has been calculated based on recent data on cefoxitine, trimethoprim/sulfamethoxazole and ciprofloxacin sensitivity EESBL, 68% of EESBL are susceptible to céfoxitine and resistant to trimethoprim/sulfamethoxazole and ciprofloxacin. In 2011, 16 French laboratories, involved in the EARSS network, isolated 582 EESBL strains from blood culture. In the university hospital of Nancy, 205 EESBL strains were isolated from urine cultures in 2012. The challenge of including 250 patients with ESBL E.coli positive urine culture, in 18 months and in about 20 participating French centers, seems highly feasible.
Recent data showed that 68% of EESBL are susceptible to céfoxitine and resistant to trimethoprim/sulfamethoxazole and ciprofloxacin. In the university hospital of Nancy, 205 EESBL strains were isolated from urine cultures in 2012. The challenge of including 250 patients with ESBL E.coli positive urine culture, in 18 months and in about 20 participating French centers, seems highly feasible.
Expected benefits for patients and/or public health Immediate benefits are expected, on an individual level and on a wider scale. Indeed for the patient, the use of narrow-specturm antibiotics, but with an equivalent efficacy, decreases the risk of selecting even more highly resistant bacteria than EESBL in the digestive tract, such as carbapenemase-producing enterobacteriaceae (CPE). A patient colonized with CPE is at high risk of developing a CPE infection and the rates of recovery are low because of the small number of antibiotics that remain effective.
At the community level, the main challenge is the preservation of carbapenems (one of the last families of antibiotics still effective in the treatment of ESBL infections), and the restriction of its usage to the treatment of severe infections only. The increasing use of carbapenems generates a high selection pressure on enterobacteriaceae which results in a worrying increase of the prevalence of CPE. Moreover, the few remaining effective antimicrobials induce high rates of side effects. The assessment of the non-inferiority of older, well-known and active molecules such as cefoxitin is a highly anticipated and encouraging research area, especially because the molecules currently under development are far from being on the market.
Title: Non-inferiority study of cefoxitin versus imipenem as treatment for non-severe urinal tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
Primary objective: to show the bacteriological non-inferiority of cefoxitin versus imipenem as a treatment for non-severe urinary tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
Secondary objectives:
- to show the clinical non-inferiority of cefoxitin versus imipenem as a treatment for non-severe urinary tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
- to evaluate the impact of cefoxitin and imipenem on the emergence on multiresistant bacteria in the digestive flora
- Conditions
- Urinary Tract Infections
- Being tested
- Cefoxitin, imipenem
- Keywords
- cefoxitin Patient safety, Infectious diseases, Extended-Spectrum β-lactamases E.coli, Antibiotics
- Medical subject headings
- Urinary Tract Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefoxitinDrug
imipenemDrug
| Study group | Role | What they receive |
|---|---|---|
| cefoxitin | Experimental | Cefoxitin 2 g administered intravenously three times a day. during 10 days for the treatment of pyelonephritis during 21 days for the treatment of prostatitis Receives: Drug: Cefoxitin |
| imipenem | Active comparator | Imimpenem 1 g administered intravenously three times a day. during 10 days for the treatment of pyelonephritis during 21 days for the treatment of prostatitis Receives: Drug: imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control urine culture negative
Measured: 7 days after the end of treatment
Secondary outcomes (3)
absence of fever
temperature lower than 38°C
Measured: 3 days after the beginning of study treatment
presence of multiresistant bacteria in a rectal swab
Measured: 7 days after the end of treatment
Composite outcome measure consisting of resolution of clinical signs observed on diagnosis
Absence of lower back pain, and/or absence of fictional burning, and/or absence of pollakiuria, and/or dysuria, and/or gross hematuria and/or abdominal pain
Measured: 7 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474706
- Sponsor's protocol ID
- PHRC N 2013/COLIFOX-MAY/SR
- Acronym
- COLIFOX
- Status last verified
- Aug 2017
- First submitted
- 4 Jun 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli
- ClinicalTrials.gov ID
- NCT02474706
- Acronym / sponsor ID
- COLIFOX / PHRC N 2013/COLIFOX-MAY/SR
- Conditions
- Urinary Tract Infections
- Keywords
- cefoxitin Patient safety, Infectious diseases, Extended-Spectrum β-lactamases E.coli, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Jun 2015 (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.
Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development.
Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems.
The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field.
Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.
Secondary objectives:
- To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.
- To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.
Detailed description
Rationale:
Commensal enterobacteriaceae of the digestive tract, mostly represented by E.coli, can cause a wide range of infections such as urinary tract infections or severe bacteraemia. For several years now, the misuse of antibiotics and cross-transmission in hospitals have led to the emergence of Enterobacteriaceae producing extended-spectrum β-lactamases (ESBL). The rising prevalence of ESBL is estimated at 8.2% in healthcare settings and at 6.2% in the community.
Carbapenems are considered the reference treatment for ESBL-producing E.coli (EESBL) infections. They often remain the last effective treatment on an individual level. But on a larger scale, their increasing use contributes to the emergence of resistance that might soon become a major public health issue.
Although the prevalence of ESBL remains low, the rate of ESBL epidemics in French hospitals has increased hugely since 2004. This could become a cause of concern especially because very few antibacterial agents are currently in development.
So infectiologists and microbiologists have to consider alternatives to carbapenems to treat infections caused by EESBL, which is stipulated in the new recommendations from the French High Council for Public Health and the Infectious Disease Society of America.
Older and well-known molecules that have proved to be effective in-vitro against EESBL may be an option. However due to a lack of conclusive studies, they're still not recommended in these cases. Cefoxitin, a cephamycin antibiotic, may be a good alternative treatment for EESBL infections and contribute to spare the use of carbapenems.
Originality and innovation:
Previous studies of cephamycins have shown encouraging results, but they were mostly cohort trials with retrospective data or subsets of non-randomized studies. So a randomized prospective non-inferiority study comparing ertapenem and cefoxitine is necessary. If the results show non-inferiority of cefoxitine versus ertapenem, immediate clinical application should ensue and lead to new recommendations, highly anticipated by the infectiologists who support this project via their clinical research network.
Project feasibility:
The pace of inclusions has been calculated based on recent data on cefoxitine, trimethoprim/sulfamethoxazole and ciprofloxacin sensitivity EESBL, 68% of EESBL are susceptible to céfoxitine and resistant to trimethoprim/sulfamethoxazole and ciprofloxacin. In 2011, 16 French laboratories, involved in the EARSS network, isolated 582 EESBL strains from blood culture. In the university hospital of Nancy, 205 EESBL strains were isolated from urine cultures in 2012. The challenge of including 250 patients with ESBL E.coli positive urine culture, in 18 months and in about 20 participating French centers, seems highly feasible.
Recent data showed that 68% of EESBL are susceptible to céfoxitine and resistant to trimethoprim/sulfamethoxazole and ciprofloxacin. In the university hospital of Nancy, 205 EESBL strains were isolated from urine cultures in 2012. The challenge of including 250 patients with ESBL E.coli positive urine culture, in 18 months and in about 20 participating French centers, seems highly feasible.
Expected benefits for patients and/or public health Immediate benefits are expected, on an individual level and on a wider scale. Indeed for the patient, the use of narrow-specturm antibiotics, but with an equivalent efficacy, decreases the risk of selecting even more highly resistant bacteria than EESBL in the digestive tract, such as carbapenemase-producing enterobacteriaceae (CPE). A patient colonized with CPE is at high risk of developing a CPE infection and the rates of recovery are low because of the small number of antibiotics that remain effective.
At the community level, the main challenge is the preservation of carbapenems (one of the last families of antibiotics still effective in the treatment of ESBL infections), and the restriction of its usage to the treatment of severe infections only. The increasing use of carbapenems generates a high selection pressure on enterobacteriaceae which results in a worrying increase of the prevalence of CPE. Moreover, the few remaining effective antimicrobials induce high rates of side effects. The assessment of the non-inferiority of older, well-known and active molecules such as cefoxitin is a highly anticipated and encouraging research area, especially because the molecules currently under development are far from being on the market.
Title: Non-inferiority study of cefoxitin versus imipenem as treatment for non-severe urinal tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
Primary objective: to show the bacteriological non-inferiority of cefoxitin versus imipenem as a treatment for non-severe urinary tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
Secondary objectives:
- to show the clinical non-inferiority of cefoxitin versus imipenem as a treatment for non-severe urinary tract infections (excluding cystitis) caused by extended spectrum beta-lactamases producing E.Coli susceptible to cefoxitin in-vitro
- to evaluate the impact of cefoxitin and imipenem on the emergence on multiresistant bacteria in the digestive flora
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cefoxitin | Experimental | Drug: CefoxitinCefoxitin 2 g administered intravenously three times a day. during 10 days for the treatment of pyelonephritis during 21 days for the treatment of prostatitis |
| imipenem | Active comparator | Drug: imipenemImimpenem 1 g administered intravenously three times a day. during 10 days for the treatment of pyelonephritis during 21 days for the treatment of prostatitis |
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
- Patient admitted to any medical or surgical department in the participating centre
- Documented urinary tract infection (other than cystitis), with or without bacteremia, caused by ESBL-producing E. coli susceptible in vitro to cefoxitin (minimal inhibition concentration <= 8 mg/L and /or diameter ≥ 19 mm according to CA-SFM 2015) and resistant to fluoroquinolones and to association trimethoprim-sulfamethoxazole. An E. Coli urinary tract infection is defined according to SPILF 2014 Clarification by a leucocytury ≥ 104/mL and clinical significant limit at 103 UFC/ml, for the men or the women.
- Medical examination prior to inclusion
- Informed consent signed by the patient
Key exclusion criteria (14 listed)
- Serious infection (severe sepsis, septic shock)
- Pregnant or breast-feeding women
- Chronic kidney failure (creatinine clearance < 30 ml/min) and/or dialysis
- Hypersensibility to imipenem/cilastatine, to cefoxitine
- Hypersensibility to another antibiotics of cephalosporine class
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 |
|---|---|---|
| Cefoxitin | Drug | cefoxitin |
| imipenem | Drug | imipenem |
Primary outcome
Control urine culture negative
Time frame: 7 days after the end of treatment
3 secondary outcomes
absence of fever
Time frame: 3 days after the beginning of study treatment
presence of multiresistant bacteria in a rectal swab
Time frame: 7 days after the end of treatment
Composite outcome measure consisting of resolution of clinical signs observed on diagnosis
Time frame: 7 days after the end of treatment
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefoxitin and imipenem in people with Urinary Tract Infections, run by Central Hospital, Nancy, France 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 6 inclusion and 14 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 11 Aug 2017. 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.
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: Lack of recruitment). 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?
Control urine culture negative (time frame: 7 days after the end of treatment). 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 11 Aug 2017.