Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin
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|ClinicalTrials.gov Identifier: NCT01720940|
Recruitment Status : Unknown
Verified November 2012 by Medicine, National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : November 2, 2012
Last Update Posted : November 2, 2012
This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.
This study will recruit 220 subjects from 2 hospitals over a period of 3 years.
Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).
|Condition or disease||Intervention/treatment||Phase|
|Infections Requiring Prolonged Duration (>10 Days) of Vancomycin||Drug: continuous vancomycin infusion Drug: intermittent vancomycin infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
|Experimental: continuous vancomycin infusion||
Drug: continuous vancomycin infusion
24-hour continuous infusion of vancomycin
Active Comparator: intermittent vancomycin infusion
vancomycin in this arm will be administered as intermittent infusion
Drug: intermittent vancomycin infusion
- nephrotoxicity [ Time Frame: occurring any time while on vancomycin treatment up to 14 days post treatment completion ]nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria
- biomarkers for detection of early nephrotoxicity [ Time Frame: measured weekly from the date of randomization until 14 days post completion of vancomycin ]serum and urine NGAL and cystatin C
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720940
|Contact: Shire Yang Tanfirstname.lastname@example.org|
|National University Hospital||Recruiting|
|Contact: Shire Yang Tan 97989001 email@example.com|
|Principal Investigator: Dale Fisher|