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Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis
The aim of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Regimen | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistimethate Sodium | Drug | Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical improvement, | time to defervescence | 7- 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | incidence of colistin related nephropathy | 14 days |
| microbiological clearance | time to clearance of cultures | 7-14 days |
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Inclusion Criteria:
Age between one year and 18 years
All paediatric cancer patients who are prescribed intravenous colistin due to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yosr Samia Abou Sedira | National Cancer Institute, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iman Sidhom | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 197881 | Background | 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. | |
| 500578 | Background | 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. |
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|
| 5486295 | Background | 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. |
| 15825037 | Background | 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. |
| 22423120 | Background | 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. |
| 23337552 | Background | 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. |
| 21676495 | Background | 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. |
| 21835694 | Background | 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. |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
| D003091 | Colistin |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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