Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)Phase 4CEF-IMPACTNCT03922919
Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)
A Phase 4 study testing Cefotaxime Injection, Rectal swab and Cefotaxime/ceftriaxone in people with Infectious Disease - Resistant Enterobacteriaceae (Diagnosis), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
- What is being tested?
- Cefotaxime Injection, Rectal swab and Cefotaxime/ceftriaxone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to Oct 2020
- 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 old
- Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
- Signed Informed Consent
Who cannot join
- Hypersensitivity to ceftriaxone or cefotaxime, to another cephalosporin or to any of the excipients of the specialities concerned.
- History of severe hypersensitivity (e.g., anaphylactic reaction) to another class of antibacterial agent of the beta-lactam family (penicillins, monobactams and carbapenes)
- Subcutaneous administration of ceftriaxone
- Pregnant and breastfeeding woman
- Suspicion of Pseudomonas infection or documented Pseudomonas infection requiring ceftazidime treatment
- Suspicion of group III enterobacteriaceae infection or group III enterobacteriaceae infection requiring cefepime treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
BOUILLER Kevin, Dr, 0381219187, kbouiller@chu-besancon.fr
About this study
Official title: Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)
The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime
- Being tested
- Cefotaxime Injection, Rectal swab, Cefotaxime/ceftriaxone
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefotaxime InjectionDrug
Systematic use of cefotaxime.
Rectal swabProcedure or surgery
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
Cefotaxime/ceftriaxoneDrug
ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician
| Study group | Role | What they receive |
|---|---|---|
| Cefotaxime or ceftriaxone group | Active comparator | free use of cefotaxime or ceftriaxone by the investigator Receives: Procedure: Rectal swab; Drug: Cefotaxime/ceftriaxone |
| Cefotaxim group | Experimental | Systematic use of cefotaxime Receives: Drug: Cefotaxime Injection; Procedure: Rectal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of digestive carrying of EB C3G-R
Frequency of occurrence of digestive carrying of EB C3G-R
Measured: 30 days after inclusion
Secondary outcomes (2)
incidence rate of EB C3G-R infections
Evaluate the effect of systematic use of cefotaxime rather than ceftriaxone on the incidence rate of EB C3G-R infections in participating departments.
Measured: 2 years
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
Compare the number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), 30 days after inclusion, between patients treated with ceftriaxone and patients treated with cefotaxime.
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start3 Apr 2018
- Primary completion3 Apr 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922919
- Sponsor's protocol ID
- API/2016/74
- Acronym
- CEF-IMPACT
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)
- ClinicalTrials.gov ID
- NCT03922919
- Acronym / sponsor ID
- CEF-IMPACT / API/2016/74
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 3 Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Apr 2019 (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.
The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Cefotaxime or ceftriaxone group | Active comparator | Procedure: Rectal swab, Drug: Cefotaxime/ceftriaxonefree use of cefotaxime or ceftriaxone by the investigator |
| Cefotaxim group | Experimental | Drug: Cefotaxime Injection, Procedure: Rectal swabSystematic use of cefotaxime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
- Signed Informed Consent
Key exclusion criteria (6 listed)
- Hypersensitivity to ceftriaxone or cefotaxime, to another cephalosporin or to any of the excipients of the specialities concerned.
- History of severe hypersensitivity (e.g., anaphylactic reaction) to another class of antibacterial agent of the beta-lactam family (penicillins, monobactams and carbapenes)
- Subcutaneous administration of ceftriaxone
- Pregnant and breastfeeding woman
- Suspicion of Pseudomonas infection or documented Pseudomonas infection requiring ceftazidime treatment
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 |
|---|---|---|
| Cefotaxime InjectionSystematic use of cefotaxime. | Drug | Cefotaxim group |
| Rectal swabRectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion | Procedure or surgery | Cefotaxim group, Cefotaxime or ceftriaxone group |
| Cefotaxime/ceftriaxoneceftriaxone or cefotaxime infusion at the discretion of the prescribing physician | Drug | Cefotaxime or ceftriaxone group |
Primary outcome
Frequency of occurrence of digestive carrying of EB C3G-R
Time frame: 30 days after inclusion
Frequency of occurrence of digestive carrying of EB C3G-R
2 secondary outcomes
incidence rate of EB C3G-R infections
Time frame: 2 years
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
Time frame: 30 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
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 Cefotaxime Injection, Rectal swab and Cefotaxime/ceftriaxone in people with Infectious Disease - Resistant Enterobacteriaceae (Diagnosis), run by Centre Hospitalier Universitaire de Besancon 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 6 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 22 Apr 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of occurrence of digestive carrying of EB C3G-R (time frame: 30 days after inclusion). 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 22 Apr 2019.