A Phase 4 interventional study of Vancomycin Continuous infusion and Vancomycin Intermittent infusion in Gram-Positive Bacterial Infections, Nephrotoxicity and Sepsis, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
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This is a randomized, controlled multicenter clinical trial. The purpose of this study is to compare the continuous infusion of vancomycin with intermittent infusion regarding the effectiveness to reach the target serum level and the relationship between infusion type and nephrotoxicity in critically ill patients.
The vancomycin is a glycopeptide antimicrobial which has been used for 50 years against gram-positive microorganisms and remains effective against multiresistant bacteria as the methicillin resistant Staphylococcus aureus (MRSA), the main microorganism causing nosocomial infections. Around the world, the continuous infusion of vancomycin has been studied and associated with less rate of nephrotoxicity. This is a randomized, controlled multicenter clinical trial that will compare continuous infusion with the intermittent vancomycin infusion, the relationship between infusion type with rate of nephrotoxicity and the time to target therapeutic serum in critically ill patients at the intensive care units of the Cancer Institute of the State of Sao Paulo (ICESP) and the Heart Institute (Incor).
58 studies on the registry are indexed under Gram-Positive Bacterial Infections; 6 are open to participants now.
This study's planned enrollment of 222 is above the median of 93 across 40 interventional studies indexed under Gram-Positive Bacterial Infections.
Browse Gram-Positive Bacterial Infections studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Continuous infusion of vancomycin
Drug: Vancomycin Continuous infusion
Intermittent infusion of vancomycin
Drug: Vancomycin Intermittent infusion
Will be administered a loading dose of 25mg/kg followed of 2g infused in 24h. Serum levels will be measured after the end of the loading dose (peak) and after 24 hours (steady state). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and area under curve (AUC) /MIC≥400mg.h/L
Also known as: Continuous infusion
Will be administered a loading dose of 25mg/kg followed of 1g every 12h. Serum levels will be measured after the end of the loading dose (peak) and one hour before the next dose (trough). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and AUC/MIC≥400mg.h/L.
Also known as: Intermittent infusion
Acute renal failure
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
Time frame: 30 days after randomization
Acute renal failure
Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
Time frame: 30 days after randomization
Hypersensibility reactions with vancomycin
Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.
Time frame: 30 days after randomization
Length of ICU stay
Therapeutic efficacy with less length of ICU stay
Time frame: 30 days after randomization
Time of treatment with the antimicrobial
Therapeutic efficacy with less time of treatment with the antimicrobial
Time frame: 30 days after randomization
Length of hospitalization
Therapeutic efficacy with less length of hospitalization
Time frame: 30 days after randomization
Mortality rate
Therapeutic efficacy with less mortality rate
Time frame: 30 days after randomization
Start is estimated for Apr 2018; primary completion for Feb 2020, 22 months later.
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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Gram-Positive Bacterial Infections →