Clinical trial NCT01266499: A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
Keywords: Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria

  1. Patient identified as a KPC carrier.
  2. Patient capable to understand and sign informed consent
  3. Age \> 18
  4. Patient capable to receive oral medication

Exclusion Criteria:

* Exclusion Criteria:

  1. Patient unable to sign informed consent
  2. Age ≤ 18
  3. Pregnant/lactating female
  4. Patient not expected to survive \> 2 weeks.
  5. Patient unable or not allowed to receive oral medications
  6. A known allergy to study drugs.

Primary outcomes:
measure: The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
timeFrame: twice a week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Mc
Study officials:
affiliation: rambam mc
name: Tsila Zuckerman, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub Investigator
name: ILANA OREN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Jacob M Rowe, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: RENATO FINKELSTEIN, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Norberto Krivoy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: HANA Shprecher, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Noam Benyamini, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Salim Hadad, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Ami Neuberger, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Eyal Braun, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Site Sub-Investigator
name: Ayelet Raz, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Center for Disease control and prevention. National Nosocomial Infections Surveillance 9NNIS0 System report, data summary from January 1992 through June 2003. Am J Infect Control 2003:31:481-98 2. 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. Antimicrobial Agents Chemother. Outbreak of Klebsiella pneumonia producing a new carbapenem-hydrolyzing class a beta-lactamase, KPC-3, in a New York Medical Center.2004;48(12):4793-9. 3. Bradford PA, Bratu S, Urban C, Visalli M, Mariano N, Landman D, Rahal JJ, Brooks S, Cebular S, Quale J Emergence of carbapenem-resistant Klebsiella species possessing the class A carbapenem-hydrolyzing KPC-2 and inhibitor-resistant TEM-30 beta-lactamases in New York City. Clin Infect Dis. 2004 1;39(1):55-60.