Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or PneumoniaNCT01266499
A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
A study testing Colistin (Polymyxin E) 100mg x 4/d, both medications and will not receive PO treatment in people with Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
- What is being tested?
- Colistin (Polymyxin E) 100mg x 4/d, both medications and will not receive PO treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jan 2012
- Phase
- Interventional
- 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
- Patient identified as a KPC carrier.
- Patient capable to understand and sign informed consent
- Age > 18
- Patient capable to receive oral medication
Who cannot join
- Patient unable to sign informed consent
- Age ≤ 18
- Pregnant/lactating female
- Patient not expected to survive > 2 weeks.
- Patient unable or not allowed to receive oral medications
- A known allergy to study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).
The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.
- Being tested
- Colistin (Polymyxin E) 100mg x 4/d, both medications, will not receive PO treatment, PO Garamycin 80mg x 4/d
- Keywords
- Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,
- Medical subject headings
- Pneumonia, Klebsiella Infections, Keratoconus posticus circumscriptus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistin (Polymyxin E) 100mg x 4/dDrug
Colistin (Polymyxin E) 100mg x 4/d
both medicationsDrug
PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
will not receive PO treatmentDrug
will not receive PO treatment - will receive plecebo treatment
PO Garamycin 80mg x 4/dDrug
PO Garamycin 80mg x 4/d
| Study group | Role | What they receive |
|---|---|---|
| Group 1: will receive PO Garamycin 80mg x 4/d | Active comparator | will receive PO Garamycin 80mg x 4/d Receives: Drug: PO Garamycin 80mg x 4/d |
| Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d | Active comparator | Not described Receives: Drug: Colistin (Polymyxin E) 100mg x 4/d |
| Group 3: will receive both medications | Active comparator | Not described Receives: Drug: both medications |
| Group 4: will not receive PO treatment | Placebo comparator | Not described Receives: Drug: will not receive PO treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
- Is this outcome measure assessing a safety issue? Select: no
Measured: twice a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2011
- Study completionJan 2012
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 Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rambam68, Rambam Health Care Campus
- Investigators
- Tsila Zuckerman, DR, Principal investigator, rambam mcILANA OREN, Dr, Principal investigator, Site Sub InvestigatorJacob M Rowe, Prof, Principal investigator, Site Sub-InvestigatorRENATO FINKELSTEIN, Prof, Principal investigator, Site Sub-InvestigatorNorberto Krivoy, Prof, Principal investigator, Site Sub-InvestigatorHANA Shprecher, Dr, Principal investigator, Site Sub-InvestigatorNoam Benyamini, Dr, Principal investigator, Site Sub-InvestigatorSalim Hadad, Dr, Principal investigator, Site Sub-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266499
- Sponsor's protocol ID
- KPCCTIL
- Status last verified
- Apr 2017
- First submitted
- 23 Dec 2010
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Woodford N, Tierno PM Jr, Young K, Tysall L, Palepou MF, Ward E, Painter RE, Suber DF, Shungu D, Silver LL, Inglima K, Kornblum J, Livermore DM. Outbreak of Klebsiella pneumoniae producing a new carbapenem-hydrolyzing class A beta-lactamase, KPC-3, in a New York Medical Center. Antimicrob Agents Chemother. 2004 Dec;48(12):4793-9. doi: 10.1128/AAC.48.12.4793-4799.2004.
PubMed 15561858
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
- ClinicalTrials.gov ID
- NCT01266499
- Acronym / sponsor ID
- KPCCTIL
- Keywords
- Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Dec 2010 (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.
Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).
The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: will receive PO Garamycin 80mg x 4/d | Active comparator | Drug: PO Garamycin 80mg x 4/dwill receive PO Garamycin 80mg x 4/d |
| Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d | Active comparator | Drug: Colistin (Polymyxin E) 100mg x 4/d |
| Group 3: will receive both medications | Active comparator | Drug: both medications |
| Group 4: will not receive PO treatment | Placebo comparator | Drug: will not receive PO treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Colistin (Polymyxin E) 100mg x 4/dColistin (Polymyxin E) 100mg x 4/d | Drug | Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d |
| both medicationsPO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d | Drug | Group 3: will receive both medications |
| will not receive PO treatmentwill not receive PO treatment - will receive plecebo treatment | Drug | Group 4: will not receive PO treatment |
| PO Garamycin 80mg x 4/dPO Garamycin 80mg x 4/d | Drug | Group 1: will receive PO Garamycin 80mg x 4/d |
Primary outcome
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
Time frame: twice a week
- Is this outcome measure assessing a safety issue? Select: no
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 Apr 2017.
- Results publication: PubMed 15561858Woodford N, Tierno PM Jr, Young K, Tysall L, Palepou MF, Ward E, Painter RE, Suber DF, Shungu D, Silver LL, Inglima K, Kornblum J, Livermore DM. Outbreak of Klebsiella pneumoniae producing a new carbapenem-hydrolyzing class A beta-lactamase, KPC-3, in a New York Medical Center. Antimicrob Agents Chemother. 2004 Dec;48(12):4793-9. doi: 10.1128/AAC.48.12.4793-4799.2004.
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.
Tsila Zuckerman, DR principal investigator
rambam mc
ILANA OREN, Dr principal investigator
Site Sub Investigator
Jacob M Rowe, Prof principal investigator
Site Sub-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colistin (Polymyxin E) 100mg x 4/d, both medications and will not receive PO treatment in people with Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia, run by Rambam Health Care Campus 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: finished, as of the sponsor's last update on 28 Apr 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 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. Some participants in this study may receive a placebo. 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?
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%). (time frame: twice a week). 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 NCT01266499, 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 28 Apr 2017.