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CompletedNCT03397914Updated Sep 16, 2020

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

A Phase 4 interventional study of Colistimethate Sodium in Gram-Negative Bacterial Infections, Pediatric Cancer and Colistin, sponsored by National Cancer Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by National Cancer Institute, Egypt · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2017, registered Jan 2018).

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Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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

Read the detailed 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
02

Conditions studied

  • Gram-Negative Bacterial Infections
  • Pediatric Cancer
  • Colistin
  • Colistin Adverse Reaction
  • MIC
03

In context

Gram-Negative Bacterial Infections

58 studies on the registry are indexed under Gram-Negative Bacterial Infections; 10 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 43 interventional studies indexed under Gram-Negative Bacterial Infections.

Browse Gram-Negative Bacterial Infections studies →

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Browse National Cancer Institute, Egypt studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Age less than one year or over 18 years
  2. Patients with renal impairment
  3. Colistin use less than 72 hours
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    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

    Drug: Colistimethate Sodium

  • Experimental
    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

    Drug: Colistimethate Sodium

Interventions

  • DrugColistimethate Sodium

    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

06

What researchers measure

Primary outcomes

  1. clinical improvement,

    time to defervescence

    Time frame: 7- 14 days

Secondary outcomes

  1. adverse events

    incidence of colistin related nephropathy

    Time frame: 14 days

  2. microbiological clearance

    time to clearance of cultures

    Time frame: 7-14 days

07

Study locations

1 site
  • Iman Sidhom
    Cairo, Cairo Governorate, Egypt
08

References and documents

Publications

  • 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. PubMed 197881 ↗
  • 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. PubMed 500578 ↗
  • 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. PubMed 5486295 ↗
  • 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. Erratum In: Clin Infect Dis. 2006 Jun 15;42(12):1819. Dosage error in article text. PubMed 15825037 ↗
  • 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. PubMed 22423120 ↗
  • 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. PubMed 23337552 ↗
  • 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. PubMed 21676495 ↗
  • 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. PubMed 21835694 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jan 2019, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2018
First posted
Jan 12, 2018
StartActual
Jan 2017
Primary completionActual
Jan 2019
CompletionActual
Mar 2019
Last update
Sep 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03397914
Lead sponsor
National Cancer Institute, Egypt
Responsible party
Sponsor
First posted
Jan 12, 2018
Start date
Jan 2017
Primary completion
Jan 2019
Completion
Mar 2019
Last update
Sep 16, 2020

Study contacts

Yosr Samia Abou Sedira
principal investigator · National Cancer Institute, Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Colistinmethanesulfonic acid

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