Safety and Efficacy Study of High Dose Colistin

King Saud Medical City

Status and phase: Unknown; Phase 4

Conditions: Infectious Diseases

Treatments: Drug: High Dose Colistin; Drug: Standard Dose Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT02162966

KSMC-CCD-AFM-002

Details and patient eligibility

About

Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  1. Patient age more than or equal 18 years old.
  2. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
  3. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.

• Exclusion Criteria:

  1. Patient age less than 18 years.
  2. Pregnant patient.
  3. If received Colistin treatment for less than 72 hours.
  4. Renal Replacement Therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

High Dose Colistin

Experimental group

Description:

High dose colistin protocol

Treatment:

Drug: High Dose Colistin

Standard Dose Colistin

Active Comparator group

Description:

Standard dose of colistin

Treatment:

Drug: Standard Dose Colistin