Clinical trial · Interventional
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
NCT03397914CI-TRIAL-00047184completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colistin | — | UNRESOLVED | — |
| Colistin Adverse Reaction | — | UNRESOLVED | — |
| Gram-Negative Bacterial Infections | — | UNRESOLVED | — |
| MIC | Microinvasive Breast Carcinoma | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colistimethate Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A Regimen
- 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
- interventionNames
- Drug: Colistimethate Sodium
- type
- EXPERIMENTAL
- label
- Group B Regimen
- 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
- interventionNames
- Drug: Colistimethate Sodium
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDStorm 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. PMID 197881
- BACKGROUNDKomura 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. PMID 500578
- BACKGROUNDBrown 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. PMID 5486295
- BACKGROUNDFalagas 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. PMID 15825037
- BACKGROUNDDalfino 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. PMID 22423120
- BACKGROUNDHernandez 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. PMID 23337552
- BACKGROUNDGupta 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.