SDD for Eradicating CRKP Carriage

S

Soroka University Medical Center

Status and phase

Unknown
Phase 4

Conditions

Carriers of Carbapenem-resistant Klebsiella Pneumonia

Treatments

Device: Gentamicin and polymyxin E

Study type

Interventional

Funder types

Other

Identifiers

NCT01761487
0285-12

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

100 participants in 1 patient group

One arm only - Gentamicin and polymyxin E
Other group
Description:
All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions
Treatment:
Device: Gentamicin and polymyxin E

Trial contacts and locations

1

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Central trial contact

Lisa Saidel-Odes, MD

Data sourced from clinicaltrials.gov

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