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Status unknownNCT02162966Updated Apr 1, 2015

Safety and Efficacy Study of High Dose Colistin

A Phase 4 interventional study of High Dose Colistin and Standard Dose Colistin in Infectious Diseases, sponsored by King Saud Medical City. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by King Saud Medical City · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infectious Diseases

Keywords

  • colistin
  • ICU
  • critical care
03

In context

Communicable Diseases

4,453 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 330 is above the median of 122 across 2,719 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

King Saud Medical City is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient age more than or equal 18 years old.

    1. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
    2. 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.

    1. Pregnant patient.
    2. If received Colistin treatment for less than 72 hours.
    3. Renal Replacement Therapy.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
330 participants (estimated)

Study arms

  • Experimental
    High Dose Colistin

    High dose colistin protocol

    Drug: High Dose Colistin

  • Active comparator
    Standard Dose Colistin

    Standard dose of colistin

    Drug: Standard Dose Colistin

Interventions

  • DrugHigh Dose Colistin

    High Dose Colistin

    Also known as: colistin

  • DrugStandard Dose Colistin

    Standard Dose Colistin

    Also known as: Colistin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 to 21 days after giving Colistin

Secondary outcomes

  1. All cause mortality

    Time frame: 7 days after the end of therapy or at 28 days after enrollment

  2. Ventilation free days

    Time frame: 28 days after enrollment

  3. Length of ICU stay

    Time frame: 28 days after enrollment

  4. Microbiological response

    whole body cultures will be done at day 7 of treatment and at the end of therapy

    Time frame: A day 7 and at the end of therapy

07

Study locations

1 of 1 sites recruiting
  • King Saud Medical City
    Riyadh, 00966, Saudi Arabia
    • Ahmed F Mady, PhD · Contact · afmady@ksmc.med.sa · 00966547060770
    • Ahmad F Mady, PhD · Principal investigator
    • Basheer A Abdelrahman, PharmD · Sub investigator
    • Muhammed A Rana, MD · Sub investigator
    • Omar A Ramadan, PhD · Sub investigator
    • Abdulrahman M Al-Harthy, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02162966
Lead sponsor
King Saud Medical City
Responsible party
Sponsor
First posted
Jun 13, 2014
Start date
May 2014
Primary completion
Oct 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Apr 1, 2015

Study contacts

Ahmed F Mady, PhD
Contact
afmady@ksmc.med.sa
00966547060770
Basheer M Abdelrahman, pharmD
Contact
00966563516815
Ahmed F Mady, PhD
principal investigator · King Saud Medical City

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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