Status:
COMPLETED
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
Lead Sponsor:
National Cancer Institute, Egypt
Conditions:
Gram-Negative Bacterial Infections
Pediatric Cancer
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- Age less than one year or over 18 years
- Patients with renal impairment
- Colistin use less than 72 hours
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03397914
Start Date
January 1 2017
End Date
March 1 2019
Last Update
September 16 2020
Active Locations (1)
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1
Iman Sidhom
Cairo, Cairo Governorate, Egypt