Gram-Positive Bacterial InfectionsPhase 4ETERNITYNCT03438214
Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients
A Phase 4 study testing Vancomycin Continuous infusion and Vancomycin Intermittent infusion in people with Gram-Positive Bacterial Infections and Nephrotoxicity, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis
- What is being tested?
- Vancomycin Continuous infusion and Vancomycin Intermittent infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Apr 2018to 1 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Critically ill patients
- Treatment with vancomycin
- Preserved renal function.
Who cannot join
- Cystic fibrosis
- Chronic renal failure
- Acute renal failure
- Having received vancomycin in the last 24 hours
- Vancomycin hypersensibility
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine University os São Paulo
São Paulo, São Paulo, 01246-903
Estela M de Oliveira, investigator, 11 98237 7000 ext. +55, estela.oliveira27@hotmail.com
Juliano P Almeida, professor, 11 98149 2592 ext. +55, doctorjuliano@yahoo.com.br
About this study
Official title: Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
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.
Read the detailed 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).
- Conditions
- Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis
- Being tested
- Vancomycin Continuous infusion, Vancomycin Intermittent infusion
- Keywords
- Vancomycin infusion, critical ill patients, MRSA
- Medical subject headings
- Gram-Positive Bacterial Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin Continuous infusionDrug
Also called 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 infusionDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin continuous infusion | Active comparator | Continuous infusion of vancomycin Receives: Drug: Vancomycin Continuous infusion |
| Vancomycin intermittent infusion | Active comparator | Intermittent infusion of vancomycin Receives: Drug: Vancomycin Intermittent infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal failure
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
Measured: 30 days after randomization
Secondary outcomes (6)
Acute renal failure
Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
Measured: 30 days after randomization
Hypersensibility reactions with vancomycin
Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.
Measured: 30 days after randomization
Length of ICU stay
Therapeutic efficacy with less length of ICU stay
Measured: 30 days after randomization
Time of treatment with the antimicrobial
Therapeutic efficacy with less time of treatment with the antimicrobial
Measured: 30 days after randomization
Length of hospitalization
Therapeutic efficacy with less length of hospitalization
Measured: 30 days after randomization
Mortality rate
Therapeutic efficacy with less mortality rate
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Apr 2018 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliano P Almeida, MD, PhD, University of Sao Paulo
- Investigators
- Juliano P Almeida, Professor, Principal investigator, University os São PauloEstela M de Oliveira, PhD student, Principal investigator, University os São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438214
- Sponsor's protocol ID
- 81226617.8.1001.0065
- Acronym
- ETERNITY
- Status last verified
- Apr 2018
- First submitted
- 5 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT03438214
- Acronym / sponsor ID
- ETERNITY / 81226617.8.1001.0065
- Conditions
- Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis
- Keywords
- Vancomycin infusion, critical ill patients, MRSA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 28 Apr 2018 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 Feb 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.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin continuous infusion | Active comparator | Drug: Vancomycin Continuous infusionContinuous infusion of vancomycin |
| Vancomycin intermittent infusion | Active comparator | Drug: Vancomycin Intermittent infusionIntermittent infusion of vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critically ill patients
- Treatment with vancomycin
- Preserved renal function.
Key exclusion criteria (5 listed)
- Cystic fibrosis
- Chronic renal failure
- Acute renal failure
- Having received vancomycin in the last 24 hours
- Vancomycin hypersensibility
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 |
|---|---|---|
| Vancomycin Continuous infusionAlso: Continuous infusionWill 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 | Drug | Vancomycin continuous infusion |
| Vancomycin Intermittent infusionAlso: Intermittent infusionWill 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. | Drug | Vancomycin intermittent infusion |
Primary outcome
Acute renal failure
Time frame: 30 days after randomization
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
6 secondary outcomes
Acute renal failure
Time frame: 30 days after randomization
Hypersensibility reactions with vancomycin
Time frame: 30 days after randomization
Length of ICU stay
Time frame: 30 days after randomization
Time of treatment with the antimicrobial
Time frame: 30 days after randomization
Length of hospitalization
Time frame: 30 days after randomization
Mortality rate
Time frame: 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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.
Juliano P Almeida, Professor principal investigator
University os São Paulo
Estela M de Oliveira, PhD student principal investigator
University os São Paulo
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 Vancomycin Continuous infusion and Vancomycin Intermittent infusion in people with Gram-Positive Bacterial Infections and Nephrotoxicity, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliano P Almeida, professor ((5511)98149-2592, doctorjuliano@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute renal failure (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2018.