Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

NCT03397914 | Completed Phase 4

• 1 other identifier: 103
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis

Conditions

Gram-Negative Bacterial Infections; Pediatric Cancer; Colistin; Colistin Adverse Reaction; MIC

Outcome Measures

Primary Outcomes (1)

• clinical improvement,

  time to defervescence

  7- 14 days

Secondary Outcomes (2)

• adverse events

  14 days

• microbiological clearance

  7-14 days

Study Arms (2)

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

Drug: Colistimethate Sodium

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

Drug: Colistimethate Sodium

Interventions

Colistimethate Sodium DRUG

Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections

Also known as: Colimycin, Colistin Sulfate, Coly-Mycin, Polymyxin E

Group A Regimen; Group B Regimen

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Age less than one year or over 18 years
• Patients with renal impairment
• Colistin use less than 72 hours

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Iman Sidhom

Cairo, Cairo Governorate, Egypt

Location

Related Publications (8)

• 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.

  PMID: 197881 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.

  PMID: 500578 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.

  PMID: 5486295 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.

  PMID: 15825037 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.

  PMID: 22423120 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.

  PMID: 23337552 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.

  PMID: 21676495 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.

  PMID: 21835694 BACKGROUND

MeSH Terms

Conditions

Gram-Negative Bacterial Infections; Neoplasms

Interventions

colistinmethanesulfonic acid; Colistin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• Yosr Samia Abou Sedira

  National Cancer Institute, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 12, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)