Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

September 14, 2020 updated by: National Cancer Institute, Egypt
Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to:

  1. Evaluate the clinical outcome of two different dosing regimen of IV colistin in the treatment of children with multidrug resistant gram-negative infections or sepsis.
  2. To estimate the frequency of colistin associated adverse effects.
  3. To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Iman Sidhom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between one year and 18 years

  2. All paediatric cancer patients who are prescribed intravenous colistin due to:

    • Sepsis due to MDR or minimally susceptible gram-negative bacteria
    • History of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.
    • Culture result consistent with MDR gram negative for this febrile neutropenic episode.
    • Patient in sepsis and colistin was administered empirically to increase antibiotic coverage.

Exclusion Criteria:

  1. Age less than one year or over 18 years
  2. Patients with renal impairment
  3. Colistin use less than 72 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A Regimen
Randomized 30 pediatric subjects suffering from febrile neutropenia with proven or suspected gram negative infection will receive 2.5 mg/kg of colistimethate sodium intravenous as loading dose followed by 1.25 mg/kg every 12 hours as maintenance dose
Drug: Colistimethate Sodium
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Other Names:
  • Polymyxin E
  • Colimycin
  • Colistin Sulfate
  • Coly-Mycin
EXPERIMENTAL: Group B Regimen
Randomized 30 pediatric subjects suffering from febrile neutropenia with proven or suspected gram negative infection will receive 5 mg/kg of colistimethate sodium intravenous as loading dose followed by 2.5 mg/kg every 12 hours as maintenance dose
Drug: Colistimethate Sodium
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Other Names:
  • Polymyxin E
  • Colimycin
  • Colistin Sulfate
  • Coly-Mycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement,
Time Frame: 7- 14 days
time to defervescence
7- 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 14 days
incidence of colistin related nephropathy
14 days
microbiological clearance
Time Frame: 7-14 days
time to clearance of cultures
7-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Yosr Samia Abou Sedira, National Cancer Institute, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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