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Completed

NCT Number: NCT03397914

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

Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis

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Key information

Conditions

Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Colistin Colistin Adverse Reaction Infections MIC Neoplasms Pediatric Cancer

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Iman Sidhom

Cairo, Cairo Governorate, Egypt

About this study

The aim of this study is to:

  • 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.
  • To estimate the frequency of colistin associated adverse effects.
  • To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between one year and 18 years
  • 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

  • Age less than one year or over 18 years
  • Patients with renal impairment
  • Colistin use less than 72 hours

Treatment and study plan

colistimethate sodium

Drug

Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections

Other names: Colimycin, Colistin Sulfate, Coly-Mycin, Polymyxin E

Primary outcomes

  1. clinical improvement,

    Time frame: 7- 14 days

    time to defervescence

Secondary outcomes

  1. adverse events

    Time frame: 14 days

    incidence of colistin related nephropathy

  2. microbiological clearance

    Time frame: 7-14 days

    time to clearance of cultures

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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