Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
1 other identifier
interventional
54
1 country
1
Brief Summary
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 30, 2011
December 1, 2011
1.9 years
December 24, 2011
December 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients with Renal toxicity associated with colistin
Renal toxicity associated with colistin according to RIFLE criteria
up to 28 days
Secondary Outcomes (1)
number of subjects with cure or improvement
up to 28 days
Study Arms (2)
Colistin
ACTIVE COMPARATORColistimethate sodium 2.5-5mg/kg iv
Colistin + Ascorbic acid
EXPERIMENTALColistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours
Interventions
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
Eligibility Criteria
You may qualify if:
- age \> 18 years hospitalized patient who needs colistin for therapy of nosocomial infection
You may not qualify if:
- pregnant woman
- lactating mother
- allergy to ascorbic acid
- receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
- received radiocontrast media within 1 week
- renal stone
- G-6-PD deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Siriraj Hospitalcollaborator
Study Sites (1)
Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.
PMID: 25801556DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Visanu Thamlikitkul, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2011
First Posted
December 30, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 30, 2011
Record last verified: 2011-12