NCT03397914

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Gram-Negative Bacterial Infections
• Pediatric Cancer
• Colistin
• Colistin Adverse Reaction
• MIC

Interventions

Type	Name	Description
DRUG	Colistimethate Sodium	Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2018-01-12
• Last updated: 2020-09-16

Locations

1 site across 1 country: Egypt