Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
NCT ID: NCT03397914
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2017-01-31
2019-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A Regimen
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
Colistimethate Sodium
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Group B Regimen
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
Colistimethate Sodium
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Interventions
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Colistimethate Sodium
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients with renal impairment
3. Colistin use less than 72 hours
1 Year
18 Years
ALL
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Principal Investigators
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Yosr Samia Abou Sedira
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Egypt
Locations
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Iman Sidhom
Cairo, Cairo Governorate, Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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103
Identifier Type: -
Identifier Source: org_study_id
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