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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03438214
Other study ID # 81226617.8.1001.0065
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received February 5, 2018
Last updated April 3, 2018
Start date April 28, 2018
Est. completion date December 1, 2022

Study information

Verified date April 2018
Source University of Sao Paulo
Contact Juliano P Almeida, professor
Phone (5511)98149-2592
Email doctorjuliano@yahoo.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 222
Est. completion date December 1, 2022
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Critically ill patients

- Treatment with vancomycin

- Preserved renal function.

Exclusion Criteria:

- Cystic fibrosis

- Chronic renal failure

- Acute renal failure

- Having received vancomycin in the last 24 hours

- Vancomycin hypersensibility

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vancomycin Continuous 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
Vancomycin Intermittent 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.

Locations

Country Name City State
Brazil Faculty of Medicine University os São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute renal failure Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network). 30 days after randomization
Secondary Acute renal failure Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network). 30 days after randomization
Secondary Hypersensibility reactions with vancomycin Skin rash, bronchospasm or anaphylaxis / anaphylactic shock. 30 days after randomization
Secondary Length of ICU stay Therapeutic efficacy with less length of ICU stay 30 days after randomization
Secondary Time of treatment with the antimicrobial Therapeutic efficacy with less time of treatment with the antimicrobial 30 days after randomization
Secondary Length of hospitalization Therapeutic efficacy with less length of hospitalization 30 days after randomization
Secondary Mortality rate Therapeutic efficacy with less mortality rate 30 days after randomization
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