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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397914
• Other study ID #: 103
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: March 2019

Study information

• Verified date: September 2020
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The aim of this study is to:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Colistin
• Colistin Adverse Reaction
• Communicable Diseases
• Gram-Negative Bacterial Infections
• Infection
• MIC
• Pediatric Cancer

Intervention

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

Locations

Country	Name	City	State
Egypt	Iman Sidhom	Cairo	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. Epub 2005 Mar 22. Review. Erratum in: Clin Infect Dis. 2006 Jun 15;42(12):1819. Dosage error in article text. — View 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. — View Citation

Hernández Orozco H, Lucas Resendiz E, Castañeda 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. — View 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. — View Citation

Storm DR, Rosenthal KS, Swanson PE. Polymyxin and related peptide antibiotics. Annu Rev Biochem. 1977;46:723-63. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement,	time to defervescence	7- 14 days
Secondary	adverse events	incidence of colistin related nephropathy	14 days
Secondary	microbiological clearance	time to clearance of cultures	7-14 days