A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Rambam Health Care Campus.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Rambam Health Care Campus
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01266499
First received: December 23, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Patients Diagnosed With Concomitant KPC Associated Disease ,Bacteremia, Pneumonia. |
Drug: Colistin (Polymyxin E) 100mg x 4/d Drug: both medications Drug: will not receive PO treatment Drug: PO Garamycin 80mg x 4/d |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Further study details as provided by Rambam Health Care Campus:
Primary Outcome Measures:
- The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%). [ Time Frame: twice a week ] [ Designated as safety issue: No ]- Is this outcome measure assessing a safety issue? Select: no
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1: will receive PO Garamycin 80mg x 4/d
will receive PO Garamycin 80mg x 4/d
|
Drug: PO Garamycin 80mg x 4/d
PO Garamycin 80mg x 4/d
|
| Active Comparator: Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d |
Drug: Colistin (Polymyxin E) 100mg x 4/d
Colistin (Polymyxin E) 100mg x 4/d
|
| Active Comparator: Group 3: will receive both medications |
Drug: both medications
PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
|
| Placebo Comparator: Group 4: will not receive PO treatment |
Drug: will not receive PO treatment
will not receive PO treatment - will receive plecebo treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Inclusion Criteria
- Patient identified as a KPC carrier.
- Patient capable to understand and sign informed consent
- Age > 18
- Patient capable to receive oral medication
Exclusion Criteria:
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266499
Locations
| Israel | |
| Rambam Mc | |
| Haifa, Israel | |
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
| Principal Investigator: | Tsila Zuckerman, DR | rambam mc |
| Principal Investigator: | ILANA OREN, Dr | Site Sub Investigator |
| Principal Investigator: | Jacob M Rowe, Prof | Site Sub-Investigator |
| Principal Investigator: | RENATO FINKELSTEIN, Prof | Site Sub-Investigator |
| Principal Investigator: | Norberto Krivoy, Prof | Site Sub-Investigator |
| Principal Investigator: | HANA Shprecher, Dr | Site Sub-Investigator |
| Principal Investigator: | Noam Benyamini, Dr | Site Sub-Investigator |
| Principal Investigator: | Salim Hadad, Dr | Site Sub-Investigator |
| Principal Investigator: | Ami Neuberger, Dr | Site Sub-Investigator |
| Principal Investigator: | Eyal Braun, Dr | Site Sub-Investigator |
| Principal Investigator: | Ayelet Raz, Dr | Site Sub-Investigator |
More Information
No publications provided
| Responsible Party: | Dr. Zuckerman- PI, Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01266499 History of Changes |
| Other Study ID Numbers: | KPCCTIL |
| Study First Received: | December 23, 2010 |
| Last Updated: | December 23, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication, |
Additional relevant MeSH terms:
|
Pneumonia Klebsiella Infections Bacteremia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Anti-Bacterial Agents Colistin Gentamicins Polymyxins Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013