Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to TemocillinTémocillineNCT03599999
Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin
An observational study of Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin
- What is being tested?
- Adverse events detection
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2017to 29 Dec 2017
- Phase
- Observational
- 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
Study population: This concerns patients over the age of 18 years old with documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin.
Who may be able to join
- documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin
Who cannot join
- History of hypersensitivity to betalactamines (rash,…)
- Patient participating in another biomedical research on a drug to avoid the risk of interactions drug
- Grafted patient
- Immunocompromised patient
- Dialysis patient (except hemodialysis patient and dialysis patient peritoneal)
Trial locations and contacts
1 site in 1 country.
About this study
The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.
Read the detailed description
The study "Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumoniae: stability, compatibility, population pharmacokinetic studies and breakpoint selection, R. De Jongh, et al, 2007 ", the author states that no adverse effects were found following injection of Temocillin. In the study "Temocillin use in England: clinical and microbiological efficacies in infections caused by extentedspectrum and / or derepressed AmpC β-lactamase-producing Enterobacteriaceae, I. Balakrishnan, et al, 2011, the author faced two cases of Clostridium difficile with a positive toxin test. The first patient received three doses of Amoxicillin / clavulanic acid followed by one week's treatment with Temocillin. This one has developed Clostridium difficile diarrhea on the last day of antibiotic treatment. The second patient did not not received Temocillin in the 6 weeks prior to diarrhea but received 8 days of Meropenem just before this diarrhea. In all cases, Temocillin can not be clearly attributed to this adverse effect and no patient developed pseudomembranous colitis.
- Being tested
- Adverse events detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse events detectionDrug
type of adverse events detected during treatment with Temocillin and imputed to Temocillin
What is being measured
The primary outcome is the main question the study is designed to answer.
number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin
Each reported case will be, first, analyzed by the principal investigator (an infectiologist), who will also be responsible for collecting information to fill out the data collection sheets and, secondarily, by the CRPV d'Amiens, which will bring its expertise in particular to define the imputability of Temocillin to the undesirable effect detected.
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 posted26 Jul 2018
- Study start24 Mar 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to TemocillinStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599999
- Sponsor's protocol ID
- PI2017_843_0003
- Acronym
- Témocilline
- Status last verified
- Sep 2018
- First submitted
- 16 Jul 2018
- Last updated
- 28 Sep 2018
- 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 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin
- ClinicalTrials.gov ID
- NCT03599999
- Acronym / sponsor ID
- Témocilline / PI2017_843_0003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 26 Jul 2018 (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 Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.
Detailed description
The study "Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumoniae: stability, compatibility, population pharmacokinetic studies and breakpoint selection, R. De Jongh, et al, 2007 ", the author states that no adverse effects were found following injection of Temocillin. In the study "Temocillin use in England: clinical and microbiological efficacies in infections caused by extentedspectrum and / or derepressed AmpC β-lactamase-producing Enterobacteriaceae, I. Balakrishnan, et al, 2011, the author faced two cases of Clostridium difficile with a positive toxin test. The first patient received three doses of Amoxicillin / clavulanic acid followed by one week's treatment with Temocillin. This one has developed Clostridium difficile diarrhea on the last day of antibiotic treatment. The second patient did not not received Temocillin in the 6 weeks prior to diarrhea but received 8 days of Meropenem just before this diarrhea. In all cases, Temocillin can not be clearly attributed to this adverse effect and no patient developed pseudomembranous colitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This concerns patients over the age of 18 years old with documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin.
Key inclusion criteria (1 listed)
- documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin
Key exclusion criteria (5 listed)
- History of hypersensitivity to betalactamines (rash,…)
- Patient participating in another biomedical research on a drug to avoid the risk of interactions drug
- Grafted patient
- Immunocompromised patient
- Dialysis patient (except hemodialysis patient and dialysis patient peritoneal)
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 |
|---|---|---|
| Adverse events detectiontype of adverse events detected during treatment with Temocillin and imputed to Temocillin | Drug | – |
Primary outcome
number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin
Time frame: 7 days after the end of treatment
Each reported case will be, first, analyzed by the principal investigator (an infectiologist), who will also be responsible for collecting information to fill out the data collection sheets and, secondarily, by the CRPV d'Amiens, which will bring its expertise in particular to define the imputability of Temocillin to the undesirable effect detected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
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?
An observational study of Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin (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 28 Sep 2018.