Safety and Efficacy Study of High Dose Colistin

NCT ID: NCT02162966

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Infectious Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Dose Colistin

High dose colistin protocol

Group Type EXPERIMENTAL

High Dose Colistin

Intervention Type DRUG

High Dose Colistin

Standard Dose Colistin

Standard dose of colistin

Group Type ACTIVE_COMPARATOR

Standard Dose Colistin

Intervention Type DRUG

Standard Dose Colistin

Interventions

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High Dose Colistin

High Dose Colistin

Intervention Type DRUG

Standard Dose Colistin

Standard Dose Colistin

Intervention Type DRUG

Other Intervention Names

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colistin Colistin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud Medical City

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed F Mady, PhD

Role: PRINCIPAL_INVESTIGATOR

King Saud Medical City

Locations

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King Saud Medical City

Riyadh, Riyadh Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Ahmed F Mady, PhD

Role: CONTACT

00966547060770

Basheer M Abdelrahman, pharmD

Role: CONTACT

00966563516815

Facility Contacts

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Ahmed F Mady, PhD

Role: primary

00966547060770

Other Identifiers

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KSMC-CCD-AFM-002

Identifier Type: -

Identifier Source: org_study_id

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