Carriers of Carbapenem-resistant Klebsiella Pneumonia Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Israel | Soroka University Medical Center | Beer Sheva | Negev |
| Lead Sponsor | Collaborator |
|---|---|
| Soroka University Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CRKP carriage at end of treatment | one year | No |