Safety and Efficacy Study of High Dose Colistin

Infectious Diseases Clinical Trial

Official title:

Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02162966
• Other study ID #: KSMC-CCD-AFM-002
• Status: Recruiting
• Phase: Phase 4
• First received: May 21, 2014
• Last updated: March 31, 2015
• Start date: May 2014
• Est. completion date: October 2016

Study information

• Verified date: March 2015
• Source: King Saud Medical City
• Contact: Ahmed F Mady, PhD
• Phone: 00966547060770
• Email: afmady[@]ksmc.med.sa
• Is FDA regulated: No
• Health authority: Saudi Arabia: Minstry of HealthSaudi Arabia: Saudi Food and Drug Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

Drug:
• High Dose Colistin
High Dose Colistin
• Standard Dose Colistin
Standard Dose Colistin

Locations

Country	Name	City	State
Saudi Arabia	King Saud Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety of high dose 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.	7 to 21 days after giving Colistin	Yes
Secondary	All cause mortality		7 days after the end of therapy or at 28 days after enrollment	Yes
Secondary	Ventilation free days		28 days after enrollment	Yes
Secondary	Length of ICU stay		28 days after enrollment	Yes
Secondary	Microbiological response	whole body cultures will be done at day 7 of treatment and at the end of therapy	A day 7 and at the end of therapy	No