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

Phase 4

Completed

• Conditions: Gram-Negative Bacterial Infections; Pediatric Cancer; Colistin; Colistin Adverse Reaction; MIC
• Interventions: Drug: Colistimethate Sodium

• Registration Number: NCT03397914
• Lead Sponsor: National Cancer Institute, Egypt

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

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Primary Completion: 2019-01
• Study Completion: 2019-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A Regimen	Colistimethate Sodium	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
Group B Regimen	Colistimethate Sodium	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

Primary Outcome Measures

Name	Time	Method
clinical improvement,	7- 14 days	time to defervescence

Secondary Outcome Measures

Name	Time	Method
adverse events	14 days	incidence of colistin related nephropathy
microbiological clearance	7-14 days	time to clearance of cultures

Trial Locations

Locations (1)

Iman Sidhom; 🇪🇬 Cairo, Cairo Governorate, Egypt