Back to resultsEffect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
Primary Purpose
Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Colistimethate Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Negative Bacterial Infections
Eligibility Criteria
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
Sites / Locations
- Iman Sidhom
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A Regimen
Group B Regimen
Arm 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
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
Outcomes
Primary Outcome Measures
clinical improvement,
time to defervescence
Secondary Outcome Measures
adverse events
incidence of colistin related nephropathy
microbiological clearance
time to clearance of cultures
Full Information
NCT ID
NCT03397914
First Posted
January 6, 2018
Last Updated
September 14, 2020
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT03397914
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin, Colistin Adverse Reaction, MIC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Regimen
Arm Type
Experimental
Arm 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
Arm Title
Group B Regimen
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Colistimethate Sodium
Other Intervention Name(s)
Colimycin, Colistin Sulfate, Coly-Mycin, Polymyxin E
Intervention Description
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Primary Outcome Measure Information:
Title
clinical improvement,
Description
time to defervescence
Time Frame
7- 14 days
Secondary Outcome Measure Information:
Title
adverse events
Description
incidence of colistin related nephropathy
Time Frame
14 days
Title
microbiological clearance
Description
time to clearance of cultures
Time Frame
7-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosr Samia Abou Sedira
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iman Sidhom
City
Cairo
State/Province
Cairo Governorate
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
197881
Citation
Storm DR, Rosenthal KS, Swanson PE. Polymyxin and related peptide antibiotics. Annu Rev Biochem. 1977;46:723-63. doi: 10.1146/annurev.bi.46.070177.003451.
Results Reference
background
PubMed Identifier
500578
Citation
Komura S, Kurahashi K. Partial purification and properties of L-2,4-diaminobutyric acid activating enzyme from a polymyxin E producing organism. J Biochem. 1979 Oct;86(4):1013-21. doi: 10.1093/oxfordjournals.jbchem.a132594.
Results Reference
background
PubMed Identifier
5486295
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.
Results Reference
background
PubMed Identifier
15825037
Citation
Falagas ME, Kasiakou SK. Colistin: the revival of polymyxins for the management of multidrug-resistant gram-negative bacterial infections. Clin Infect Dis. 2005 May 1;40(9):1333-41. doi: 10.1086/429323. Epub 2005 Mar 22. Erratum In: Clin Infect Dis. 2006 Jun 15;42(12):1819. Dosage error in article text.
Results Reference
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PubMed Identifier
22423120
Citation
Dalfino L, Puntillo F, Mosca A, Monno R, Spada ML, Coppolecchia S, Miragliotta G, Bruno F, Brienza N. High-dose, extended-interval colistin administration in critically ill patients: is this the right dosing strategy? A preliminary study. Clin Infect Dis. 2012 Jun;54(12):1720-6. doi: 10.1093/cid/cis286. Epub 2012 Mar 15.
Results Reference
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PubMed Identifier
23337552
Citation
Hernandez Orozco H, Lucas Resendiz E, Castaneda JL, De Colsa A, Ramirez Mayans J, Johnson KM, Gonzalez N, Caniza MA. Surveillance of healthcare associated infections in pediatric cancer patients between 2004 and 2009 in a public pediatric hospital in Mexico city, Mexico. J Pediatr Hematol Oncol. 2014 Mar;36(2):96-8. doi: 10.1097/MPH.0b013e31827e7f4c.
Results Reference
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PubMed Identifier
21676495
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.
Results Reference
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PubMed Identifier
21835694
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.
Results Reference
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Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
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