Carriers of Carbapenem-resistant Klebsiella PneumoniaPhase 4NCT01761487
SDD for Eradicating CRKP Carriage
A Phase 4 study testing Gentamicin and polymyxin E in people with Carriers of Carbapenem-resistant Klebsiella Pneumonia, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carriers of Carbapenem-resistant Klebsiella Pneumonia
- What is being tested?
- Gentamicin and polymyxin E
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Feb 2014
- 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
- Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
- Hospitalized men or women at least 18 years of age
- Rectal swab culture positive for CRKP in the last week
- Will be willing to initiate and remain on treatment, except for adverse events occurring
Who cannot join
- Age less than 18 years.
- Pregnant women, lactating women.
- A know allergy to one of the study drugs.
- Renal failure with creatinine clearance less than 50mL/min.
- Current Treatment with IV gentamicin and/or IV polymyxin E
- Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS
There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).
In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.
The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.
- Being tested
- Gentamicin and polymyxin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin and polymyxin EDevice
| Study group | Role | What they receive |
|---|---|---|
| One arm only - Gentamicin and polymyxin E | Other | All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions Receives: Device: Gentamicin and polymyxin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRKP carriage at end of treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carriers of Carbapenem-resistant Klebsiella PneumoniaStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761487
- Sponsor's protocol ID
- 0285-12
- Status last verified
- Oct 2012
- First submitted
- 3 Jan 2013
- Last updated
- 4 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS
- ClinicalTrials.gov ID
- NCT01761487
- Acronym / sponsor ID
- 0285-12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (estimated)
- First posted
- 4 Jan 2013 (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.
There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).
In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.
The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm only - Gentamicin and polymyxin E | Other | Device: Gentamicin and polymyxin EAll subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
- Hospitalized men or women at least 18 years of age
- Rectal swab culture positive for CRKP in the last week
- Will be willing to initiate and remain on treatment, except for adverse events occurring
Key exclusion criteria (6 listed)
- Age less than 18 years.
- Pregnant women, lactating women.
- A know allergy to one of the study drugs.
- Renal failure with creatinine clearance less than 50mL/min.
- Current Treatment with IV gentamicin and/or IV polymyxin E
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 |
|---|---|---|
| Gentamicin and polymyxin E | Device | One arm only - Gentamicin and polymyxin E |
Primary outcome
CRKP carriage at end of treatment
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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 Gentamicin and polymyxin E in people with Carriers of Carbapenem-resistant Klebsiella Pneumonia, run by Soroka University Medical Center at 1 site in Israel.
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 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 4 Jan 2013. 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 Israel. 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?
Contact Lisa Saidel-Odes, MD (972-8-6400370, saidelod@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRKP carriage at end of treatment (time frame: one year). 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 4 Jan 2013.