SDD for Eradicating CRKP Carriage

SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01761487

Enrollment

100

Registered

2013-01-04

Start date

2013-01-31

Completion date

Unknown

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carriers of Carbapenem-resistant Klebsiella Pneumonia

Brief 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). 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.

Interventions

DEVICEGentamicin and polymyxin E

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CRKP carriage at end of treatment	one year

Countries

Israel

Contacts

Primary ContactLisa Saidel-Odes, MD

saidelod@bgu.ac.il972-8-6400370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026