Safety and Efficacy Study of High Dose Colistin

Phase 4

• Conditions: Infectious Diseases
• Interventions: Drug: Standard Dose Colistin; Drug: High Dose Colistin

• Registration Number: NCT02162966
• Lead Sponsor: King Saud Medical City

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-13
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dose Colistin	Standard Dose Colistin	Standard dose of colistin
High Dose Colistin	High Dose Colistin	High dose colistin protocol

Primary Outcome Measures

Name	Time	Method
Evaluate safety of high dose Colistin	7 to 21 days after giving Colistin	Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients.; The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	28 days after enrollment
Microbiological response	A day 7 and at the end of therapy	whole body cultures will be done at day 7 of treatment and at the end of therapy
All cause mortality	7 days after the end of therapy or at 28 days after enrollment
Ventilation free days	28 days after enrollment

Trial Locations

Locations (1)

King Saud Medical City; 🇸🇦 Riyadh, Saudi Arabia