A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).

Rambam Health Care Campus

Status: Completed

Conditions: Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Treatments: Drug: PO Garamycin 80mg x 4/d; Drug: will not receive PO treatment; Drug: Colistin (Polymyxin E) 100mg x 4/d; Drug: both medications

Study type: Interventional

Funder types: Other

Identifiers

NCT01266499

KPCCTIL

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups, including a placebo group

Group 1: will receive PO Garamycin 80mg x 4/d

Active Comparator group

Description:

will receive PO Garamycin 80mg x 4/d

Treatment:

Drug: PO Garamycin 80mg x 4/d

Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d

Active Comparator group

Treatment:

Drug: Colistin (Polymyxin E) 100mg x 4/d

Group 3: will receive both medications

Active Comparator group

Treatment:

Drug: both medications

Group 4: will not receive PO treatment

Placebo Comparator group

Treatment:

Drug: will not receive PO treatment