Gram-Negative Bacterial InfectionsPhase 4NCT03397914
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
A Phase 4 study testing Colistimethate Sodium in people with Gram-Negative Bacterial Infections and Pediatric Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin
- What is being tested?
- Colistimethate Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Age less than one year or over 18 years
- Patients with renal impairment
- Colistin use less than 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- To estimate the frequency of colistin associated adverse effects.
- To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome
- Conditions
- Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin, Colistin Adverse Reaction, MIC
- Being tested
- Colistimethate Sodium
- Medical subject headings
- Gram-Negative Bacterial Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistimethate SodiumDrug
Also called Colimycin, Colistin Sulfate, Coly-Mycin, Polymyxin E
Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Colistimethate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement,
time to defervescence
Measured: 7- 14 days
Secondary outcomes (2)
adverse events
incidence of colistin related nephropathy
Measured: 14 days
microbiological clearance
time to clearance of cultures
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study startJan 2017
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gram-Negative Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yosr Samia Abou Sedira, Principal investigator, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397914
- Sponsor's protocol ID
- 103
- Status last verified
- Sep 2020
- First submitted
- 6 Jan 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 197881Komura 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 500578Brown 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 5486295Falagas 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.
PubMed 15825037Dalfino 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 22423120Hernandez 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 23337552Gupta 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 21676495Bergen 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
- ClinicalTrials.gov ID
- NCT03397914
- Acronym / sponsor ID
- 103
- Conditions
- Gram-Negative Bacterial Infections, Pediatric Cancer, Colistin, Colistin Adverse Reaction, MIC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis
Detailed description
The aim of this study is to:
- 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.
- To estimate the frequency of colistin associated adverse effects.
- To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Regimen | Experimental | Drug: Colistimethate SodiumRandomized 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 | Drug: Colistimethate SodiumRandomized 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 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between one year and 18 years
- All paediatric cancer patients who are prescribed intravenous colistin due to:
Key exclusion criteria (3 listed)
- Age less than one year or over 18 years
- Patients with renal impairment
- Colistin use less than 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colistimethate SodiumAlso: Colimycin, Colistin Sulfate, Coly-Mycin, Polymyxin EIntravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections | Drug | Group A Regimen, Group B Regimen |
Primary outcome
clinical improvement,
Time frame: 7- 14 days
time to defervescence
2 secondary outcomes
adverse events
Time frame: 14 days
microbiological clearance
Time frame: 7-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 197881Storm 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.
- Background: PubMed 500578Komura 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.
- Background: PubMed 5486295Brown 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.
- Background: PubMed 15825037Falagas 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.
- Background: PubMed 22423120Dalfino 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.
- Background: PubMed 23337552Hernandez 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.
- Background: PubMed 21676495Gupta 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.
- Background: PubMed 21835694Bergen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yosr Samia Abou Sedira principal investigator
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colistimethate Sodium in people with Gram-Negative Bacterial Infections and Pediatric Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement, (time frame: 7- 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397914, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.