Outcome, FatalNCT04277143
A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney
An observational study of Outcome, Fatal and Infection, run by Zhongnan Hospital at 1 site in China.
Trial summary
Daptomycin ，is the first approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains，disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Outcome, Fatal, Infection
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to the Department of Critical Medicine, Zhongnan Hospital of Wuhan University , considering bloodstream infections caused by Gram-positive bacteria。
Who may be able to join
- Patients with severe bloodstream infections eligible for daptomycin indications
- Treatment in the ICU
- Patients aged 18 to 65
Who cannot join
- Pregnant and lactating women
- The patient or his agent refused to participate in the trial
- Incomplete clinical medical information
- Patient participates in another clinical trial at the same time
- Previous history of myopathy or current CPK increase more than 2 times than normal
- Patients need to use warfarin anticoagulation
Show all 10Show fewer
- Patients use tobramycin for anti-infection
- Patients use drugs such as cyclosporine and fibrates that can cause adverse reactions to muscle disease
- Patients with Gram-negative bacterial infections caused by abdominal and respiratory infections
- Patients with heart failure, respiratory failure, Glasgow coma index (GCS) ≤ 8 points, liver function CHILD PUGH score C that are not related to the infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence Factors of Pharmacokinetics/Pharmacodynamics of Daptomycin in Severe Patients and the the Effect of Different Blood Concentration of Daptomycin on the Outcomes of Renal Function
Daptomycin ，is the first approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains，disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. Because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. Daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys.
There is still a lot of controversy about the application of daptomycin in patients with severe illness. Although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. In addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (AKI), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of Daptomycin.
By exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin PK/PD, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.
- Conditions
- Outcome, Fatal, Infection
- Being tested
- Daptomycin
- Keywords
- daptomycin, pharmacokinetics, pharmacodynamics, critical ill patients, outcome
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Adult patients are given the recommended dose of daptomycin for injection. Patients with creatinine clearance (CLCR) ≥ 30 mL / min: 6 mg / kg every 24 hours.
Patients with creatinine clearance (CLCR) <30mL / min (including hemodialysis or peritoneal dialysis): 6mg / kg every 48 hours. Dissolve 6mg / kg of this drug in 0.9% sodium chloride injection and instill it over a 30-minute time course once every 24 or 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| critical ill patient with bloodstream infections | Severe patients with bloodstream infections often have sepsis / septic shock, acute kidney injury (AKI), hypoproteinemia, and renal replacement treatment. Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent volume of distribution
Apparent volume of distribution of daptomycin in the patient's blood
Measured: 1 week
Peak plasma concentration
Peak plasma concentration of daptomycin
Measured: 1 week
Plasma trough concentration
Plasma trough concentration of daptomycin
Measured: 1 week
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of daptomycin
Measured: 1 week
Clearance of daptomycin
Daptomycin is metabolized mainly by the kidneys
Measured: 1 week
Half-life
Half-life of plasma daptomycin
Measured: 1 week
Protein binding rate
Reversible binding of daptomycin to plasma proteins (mainly serum albumin)
Measured: 1 week
Serum creatinine
Serum creatinine can reflect kidney function
Measured: 1 week
Urine output
Urine volume can reflect kidney function
Measured: 1 week
Blood Urea Nitrogen
It can reflect kidney function
Measured: 1 week
Urine protein
Reflect kidney function
Measured: 1 week
Cystatin C
Reflect kidney function
Measured: 1 week
β2-microglobulin(β2-MG)
Reflect kidney function
Measured: 1 week
Major Adverse kidney Event（MAKE）
Major Adverse kidney Event（MAKE）Refers to death, need for renal replacement therapy, and creatinine levels that are twice or more the baseline value；It can reflects the outcome of renal function.
Measured: 28days
ICU mortality
Reflect patient prognosis
Measured: 28days
In-hospital mortality
Reflect patient prognosis
Measured: 28days
ICU hospital stay length
Reflect patient prognosis
Measured: 28 days
Total hospital stay length
Reflect patient prognosis
Measured: 28 days
Secondary outcomes (8)
White blood cell count
Reflect the severity of the patient's infection
Measured: 1 week
Neutrophil ratio
Reflect the severity of the patient's infection
Measured: 1 week
C-Reactive Protein
Reflect the severity of the patient's infection
Measured: 1 week
Procalcitonin
Reflect the severity of the patient's infection
Measured: 1 week
Interleukin-6
Reflect the severity of the patient's infection
Measured: 1 week
Bacterial culture results
Reflect the severity of the patient's infection
Measured: 1 week
Body temperature
Reflect the severity of the patient's infection
Measured: 1 week
Vascular drug use days
Assess patients' systemic circulation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, FatalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiYong Peng, Zhongnan Hospital
- Investigators
- Zhiyong Peng, Professor, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277143
- Sponsor's protocol ID
- 2019018
- Status last verified
- Nov 2020
- First submitted
- 16 Feb 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Factors of Pharmacokinetics/Pharmacodynamics of Daptomycin in Severe Patients and the the Effect of Different Blood Concentration of Daptomycin on the Outcomes of Renal Function
- ClinicalTrials.gov ID
- NCT04277143
- Acronym / sponsor ID
- 2019018
- Conditions
- Outcome, Fatal, Infection
- Keywords
- daptomycin, pharmacokinetics, pharmacodynamics, critical ill patients, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Feb 2020 (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.
Daptomycin ，is the first approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains，disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. Because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. Daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys.
There is still a lot of controversy about the application of daptomycin in patients with severe illness. Although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. In addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (AKI), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of Daptomycin.
By exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin PK/PD, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical ill patient with bloodstream infections | – | Drug: DaptomycinSevere patients with bloodstream infections often have sepsis / septic shock, acute kidney injury (AKI), hypoproteinemia, and renal replacement treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of Critical Medicine, Zhongnan Hospital of Wuhan University , considering bloodstream infections caused by Gram-positive bacteria。
Key inclusion criteria (3 listed)
- Patients with severe bloodstream infections eligible for daptomycin indications
- Treatment in the ICU
- Patients aged 18 to 65
Key exclusion criteria (10 listed)
- Pregnant and lactating women
- The patient or his agent refused to participate in the trial
- Incomplete clinical medical information
- Patient participates in another clinical trial at the same time
- Previous history of myopathy or current CPK increase more than 2 times than normal
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 |
|---|---|---|
| DaptomycinAdult patients are given the recommended dose of daptomycin for injection. Patients with creatinine clearance (CLCR) ≥ 30 mL / min: 6 mg / kg every 24 hours. Patients with creatinine clearance (CLCR) <30mL / min (including hemodialysis or peritoneal dialysis): 6mg / kg every 48 hours. Dissolve 6mg / kg of this drug in 0.9% sodium chloride injection and instill it over a 30-minute time course once every 24 or 48 hours. | Drug | critical ill patient with bloodstream infections |
Primary outcome
Apparent volume of distribution
Time frame: 1 week
Apparent volume of distribution of daptomycin in the patient's blood
Peak plasma concentration
Time frame: 1 week
Peak plasma concentration of daptomycin
Plasma trough concentration
Time frame: 1 week
Plasma trough concentration of daptomycin
Area under the plasma concentration versus time curve (AUC)
Time frame: 1 week
Area under the plasma concentration versus time curve (AUC) of daptomycin
Clearance of daptomycin
Time frame: 1 week
Daptomycin is metabolized mainly by the kidneys
Half-life
Time frame: 1 week
Half-life of plasma daptomycin
Protein binding rate
Time frame: 1 week
Reversible binding of daptomycin to plasma proteins (mainly serum albumin)
Serum creatinine
Time frame: 1 week
Serum creatinine can reflect kidney function
Urine output
Time frame: 1 week
Urine volume can reflect kidney function
Blood Urea Nitrogen
Time frame: 1 week
It can reflect kidney function
Urine protein
Time frame: 1 week
Reflect kidney function
Cystatin C
Time frame: 1 week
Reflect kidney function
β2-microglobulin(β2-MG)
Time frame: 1 week
Reflect kidney function
Major Adverse kidney Event（MAKE）
Time frame: 28days
Major Adverse kidney Event（MAKE）Refers to death, need for renal replacement therapy, and creatinine levels that are twice or more the baseline value；It can reflects the outcome of renal function.
ICU mortality
Time frame: 28days
Reflect patient prognosis
In-hospital mortality
Time frame: 28days
Reflect patient prognosis
ICU hospital stay length
Time frame: 28 days
Reflect patient prognosis
Total hospital stay length
Time frame: 28 days
Reflect patient prognosis
8 secondary outcomes
White blood cell count
Time frame: 1 week
Neutrophil ratio
Time frame: 1 week
C-Reactive Protein
Time frame: 1 week
Procalcitonin
Time frame: 1 week
Interleukin-6
Time frame: 1 week
Bacterial culture results
Time frame: 1 week
Body temperature
Time frame: 1 week
Vascular drug use days
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Zhiyong Peng, Professor principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, Fatal and Infection, run by Zhongnan Hospital at 1 site in China.
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 10 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 13 Nov 2020. 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 China. 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.
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 Zhiyong Peng, Professor (+8618672396028, pengzy5@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent volume of distribution (time frame: 1 week). The study lists 18 primary outcomes in all. 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 13 Nov 2020.