Elderly InfectionNCT04799626
Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients
An observational study of Elderly Infection, run by Shandong University at 1 site in China.
Trial summary
The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Elderly Infection
- What is being tested?
- biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Jun 2023
- How long will I take part?
- 3 Days
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly ICU patients (≥65years）treated with biapenem,meropenem,piperacillin and tazobactam,tigecycline and levofloxacin.etc who was hospitalized in the Second Hospital of Shandong University.
Who may be able to join
- (1) Age ≥65 years old; (2) According to the doctor's advice, use biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc for anti-infection treatment;
Who cannot join
- (1) Patients who are expected to die within 48 hours; (2) Patients with allergic to β-lactam antibiotics, Carbapenems, Ticacycline and Levofloxacin.etc drugs; (3) Patients receiving other investigational drugs; (4) Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wei Zhao
Jinan, Shandong
Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: Population Pharmacokinetics and Dosage Individualization of Biapenem,Meropenem,Piperacillin and Tazobactam,Tigecycline,Levofloxacin .Etc in Elderly Patients Who Was Hospitalized in Intensive Care Unit
The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics.
Read the detailed description
The use of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients during clinical treatment depended mostly on experience. Besides, there was no recommended dose for elderly patients in drug instruction, Therefore, we aim to study the pharmacokinetics and pharmacodynamics in elderly ICU patients and provide a tailormade regimen.
- Conditions
- Elderly Infection
- Being tested
- biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
- Keywords
- biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc, elderly ICU patients, dosage regimen, pharmacokinetics and pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etcDrug
biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc extended infusion time or continuous infusion for 24 hours;Tigecycline changed standard does for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | The use of antimicrobial agents depends on the clinical practice. Receives: Drug: biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc after intravenous administration.
Measured: at (5-10) minutes after intravenous administration
The random plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the random plasma and cerebrospinal fluid drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
Measured: at (0.5-10) hours after intravenous administration
The trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
Measured: at 1-2 hours before the next administration
Secondary outcomes (2)
C-reaction protein
Blood routine examination
Measured: Through study completion, an average of 14 days
level of procalcitonin
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Shandong University
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Study chair, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799626
- Sponsor's protocol ID
- 2021-Antibiotics-009
- Status last verified
- Jun 2022
- First submitted
- 14 Mar 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Dosage Individualization of Biapenem,Meropenem,Piperacillin and Tazobactam,Tigecycline,Levofloxacin .Etc in Elderly Patients Who Was Hospitalized in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04799626
- Acronym / sponsor ID
- 2021-Antibiotics-009
- Conditions
- Elderly Infection
- Keywords
- biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc, elderly ICU patients, dosage regimen, pharmacokinetics and pharmacodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- The Second Hospital of Shandong University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Mar 2021 (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.
The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics.
Detailed description
The use of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients during clinical treatment depended mostly on experience. Besides, there was no recommended dose for elderly patients in drug instruction, Therefore, we aim to study the pharmacokinetics and pharmacodynamics in elderly ICU patients and provide a tailormade regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etcThe use of antimicrobial agents depends on the clinical practice. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly ICU patients (≥65years）treated with biapenem,meropenem,piperacillin and tazobactam,tigecycline and levofloxacin.etc who was hospitalized in the Second Hospital of Shandong University.
Key inclusion criteria (1 listed)
- (1) Age ≥65 years old; (2) According to the doctor's advice, use biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc for anti-infection treatment;
Key exclusion criteria (1 listed)
- (1) Patients who are expected to die within 48 hours; (2) Patients with allergic to β-lactam antibiotics, Carbapenems, Ticacycline and Levofloxacin.etc drugs; (3) Patients receiving other investigational drugs; (4) Other factors that the researcher considers unsuitable for inclusion.
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 |
|---|---|---|
| biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etcbiapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc extended infusion time or continuous infusion for 24 hours;Tigecycline changed standard does for treatment. | Drug | Treatment |
Primary outcome
The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
Time frame: at (5-10) minutes after intravenous administration
To detect the peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc after intravenous administration.
The random plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
Time frame: at (0.5-10) hours after intravenous administration
To detect the random plasma and cerebrospinal fluid drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
The trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
Time frame: at 1-2 hours before the next administration
To detect the trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
2 secondary outcomes
C-reaction protein
Time frame: Through study completion, an average of 14 days
level of procalcitonin
Time frame: Through study completion, an average of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
Related trials for Elderly Infection
Enrolling by invitationObservational study
ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients
Severe Community-Acquired Pneumonia (sCAP), Elderly Infection
Recruiting
Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
Elderly, Antibiotics Overuse
Active, not recruitingObservational study
Long COVID and Its Associations With Health Outcomes in Older Adults
Long COVID, COVID-19 Pandemic
RecruitingObservational study
Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
HIV Infections, Drug Interaction
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.
Wei Zhao, Ph.D study chair
The Second Hospital of Shandong 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 Elderly Infection, run by Shandong University 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 1 inclusion and 1 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 23 Jun 2022. 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 Wei Zhao, Ph.D (053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc (time frame: at (5-10) minutes after intravenous administration). The study lists 3 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 23 Jun 2022.