CarbapenemNCT03094494
Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections
An observational study of Carbapenem and Klebsiella Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenem, Klebsiella Pneumonia
- What is being tested?
- none intervention
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 31 Dec 2016
- 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: Critically ill patients with severe CR-Kp infection
Who may be able to join
- age ≥ 18 years;
- ICU admission between November 2012 and December 2015;
- documented CR-Kp invasive infection;
- targeted antibiotic therapy lasting ≥ 72 hours
Who cannot join
- Klebsiella infection, susceptible to carbapenems
- Duration of antimicrobial therapy less than 72 hours
- Data not completely available from the electronically medical chart
About this study
Official title: Double Carbapenem as Rescue Strategy for the Treatment of Severe Carbapenemase-Producing Klebsiella Pneumoniae Infections: A Two-Center Matched Case-Control Study
An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection
- Conditions
- Carbapenem, Klebsiella Pneumonia
- Being tested
- none intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
none intervention
| Study group | Role | What they receive |
|---|---|---|
| Double Carbapenem Group | Patients underwent Double carbapenem treatment Receives: Other: none intervention | |
| Standard Treatment Group | Patients who were not treated with the double carbapenem Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
mortality after 28 day from infection
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Nov 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarbapenemStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gennaro De Pascale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094494
- Sponsor's protocol ID
- UCSC14669/15 359/2015
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
De Pascale G, Martucci G, Montini L, Panarello G, Cutuli SL, Di Carlo D, Di Gravio V, Di Stefano R, Capitanio G, Vallecoccia MS, Polidori P, Spanu T, Arcadipane A, Antonelli M. Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case-control study. Crit Care. 2017 Jul 5;21(1):173. doi: 10.1186/s13054-017-1769-z.
PubMed 28679413
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Carbapenem as Rescue Strategy for the Treatment of Severe Carbapenemase-Producing Klebsiella Pneumoniae Infections: A Two-Center Matched Case-Control Study
- ClinicalTrials.gov ID
- NCT03094494
- Acronym / sponsor ID
- UCSC14669/15 359/2015
- Conditions
- Carbapenem, Klebsiella Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 29 Mar 2017 (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.
An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Carbapenem Group | – | Other: none interventionPatients underwent Double carbapenem treatment |
| Standard Treatment Group | – | Other: none interventionPatients who were not treated with the double carbapenem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with severe CR-Kp infection
Key inclusion criteria (4 listed)
- age ≥ 18 years;
- ICU admission between November 2012 and December 2015;
- documented CR-Kp invasive infection;
- targeted antibiotic therapy lasting ≥ 72 hours
Key exclusion criteria (3 listed)
- Klebsiella infection, susceptible to carbapenems
- Duration of antimicrobial therapy less than 72 hours
- Data not completely available from the electronically medical chart
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 |
|---|---|---|
| none interventionnone intervention | Other | Double Carbapenem Group, Standard Treatment Group |
Primary outcome
28-day mortality
Time frame: 28 day
mortality after 28 day from infection
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 29 Mar 2017.
- Derived from this study: PubMed 28679413De Pascale G, Martucci G, Montini L, Panarello G, Cutuli SL, Di Carlo D, Di Gravio V, Di Stefano R, Capitanio G, Vallecoccia MS, Polidori P, Spanu T, Arcadipane A, Antonelli M. Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case-control study. Crit Care. 2017 Jul 5;21(1):173. doi: 10.1186/s13054-017-1769-z.
- Individual participant dataSharing planned: Yes
Related trials for Carbapenem
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
RecruitingPhase 2
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia
Not yet recruitingObservational study
Wastewater Surveillance for Carbapenem-Resistant Organism Outbreak Prediction in a Chinese Tertiary Hospital
Drug Resistance, Bacterial, Carbapenems
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem and Klebsiella Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 3 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 29 Mar 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.
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?
28-day mortality (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094494, which also lists 1 linked publication.
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 29 Mar 2017.