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

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

Detailed Description
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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

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

Conditions
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Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin, Colistin Adverse Reaction, MIC

Intervention / Treatment
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* Drug: Colistimethate Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Regimen<br>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<br>* Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections<br>* Other names: Polymyxin E;|
| Experimental: Group B Regimen<br>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<br>* Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections<br>* Other names: Polymyxin E;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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