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

National Cancer Institute, Egypt

Status and phase: Completed; Phase 4

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

Treatments: Drug: Colistimethate Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03397914

103

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group A Regimen

Experimental group

Description:

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

Treatment:

Drug: Colistimethate Sodium

Group B Regimen

Experimental group

Description:

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

Treatment:

Drug: Colistimethate Sodium