Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin, Colistin Adverse Reaction, MIC
Conditions
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. 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
Interventions
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement, | 7- 14 days | time to defervescence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 14 days | incidence of colistin related nephropathy |
| microbiological clearance | 7-14 days | time to clearance of cultures |
Countries
Egypt
Outcome results
None listed