Clinical trial NCT03397914: Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
Official title: Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gram-Negative Bacterial Infections
Pediatric Cancer
Colistin
Colistin Adverse Reaction
MIC
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: clinical improvement,
timeFrame: 7- 14 days
Secondary outcomes:
measure: adverse events
timeFrame: 14 days
measure: microbiological clearance
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Iman Sidhom
state: Cairo Governorate
Study officials:
affiliation: National Cancer Institute, Egypt
name: Yosr Samia Abou Sedira
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brown JM, Dorman DC, Roy LP. Acute renal failure due to overdosage of colistin. Med J Aust. 1970 Nov 14;2(20):923-4. doi: 10.5694/j.1326-5377.1970.tb63262.x. No abstract available.
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citation: Gupta A, Kapil A, Lodha R, Kabra SK, Sood S, Dhawan B, Das BK, Sreenivas V. Burden of healthcare-associated infections in a paediatric intensive care unit of a developing country: a single centre experience using active surveillance. J Hosp Infect. 2011 Aug;78(4):323-6. doi: 10.1016/j.jhin.2011.04.015. Epub 2011 Jun 14.
citation: Bergen PJ, Li J, Nation RL. Dosing of colistin-back to basic PK/PD. Curr Opin Pharmacol. 2011 Oct;11(5):464-9. doi: 10.1016/j.coph.2011.07.004. Epub 2011 Aug 9.