EravacyclineNCT06666998
Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
An observational study of Eravacycline and Pharmacokinetics, run by Sichuan Provincial People's Hospital.
Trial summary
The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eravacycline, Pharmacokinetics, Bacteria Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 critically infected patients
Who may be able to join
- Adult male or female aged 18-75 years
- Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
- Empirical antimicrobial treatment is ineffective
- Eravacycline application for ≥ 3 days
- Understand and sign informed consent
Who cannot join
- Urinary tract infection
- Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
- Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
- Patients expected to survive for no longer than 48h.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Measured: At the end of treatment；2 weeks（estimated）
Microbiological efficacy
Evaluate at the end of treatment and at post-treatment (discharge) in patients who met all clinical evaluation criteria and who had positive bacteriologic cultures prior to treatment, and bacterial clearance was calculated using the results of post-treatment follow-up (discharge) as the primary endpoint of evaluation.Performing safety observation (including coagulation dysfunction and other adverse reactions)
Measured: From enrollment to the end of treatment at 28 days
Secondary outcomes (1)
Develop Population Pharmacokinetic Model
Initial testing perform at first dose and steady-state testing perform at the seventh dose.Calculation of all-eravacycline fAUC using the linear trapezoidal method.Multiple regression analysis use to generate the best model equation for estimating the fAUC using the concentration of eravacycline at each sampling point in the modeling group as the independent variable and the fAUC as the dependent variable.
Measured: From enrollment to the end of treatment at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EravacyclineStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666998
- Sponsor's protocol ID
- LPan2
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
- ClinicalTrials.gov ID
- NCT06666998
- Acronym / sponsor ID
- LPan2
- Conditions
- Eravacycline, Pharmacokinetics, Bacteria Infection, Bacterial Resistance to Antimicrobial, Empirical Antimicrobial Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 31 Oct 2024 (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 aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 critically infected patients
Key inclusion criteria (5 listed)
- Adult male or female aged 18-75 years
- Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
- Empirical antimicrobial treatment is ineffective
- Eravacycline application for ≥ 3 days
- Understand and sign informed consent
Key exclusion criteria (4 listed)
- Urinary tract infection
- Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
- Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
- Patients expected to survive for no longer than 48h.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical remission rate
Time frame: At the end of treatment；2 weeks（estimated）
Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Microbiological efficacy
Time frame: From enrollment to the end of treatment at 28 days
Evaluate at the end of treatment and at post-treatment (discharge) in patients who met all clinical evaluation criteria and who had positive bacteriologic cultures prior to treatment, and bacterial clearance was calculated using the results of post-treatment follow-up (discharge) as the primary endpoint of evaluation.Performing safety observation (including coagulation dysfunction and other adverse reactions)
1 secondary outcome
Develop Population Pharmacokinetic Model
Time frame: From enrollment to the end of treatment at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Eravacycline
RecruitingPhase 2
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Complicated Intra-abdominal Infections (cIAI)
RecruitingPhase 2
Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
Hematological Malignancy, Neutropenia
Enrolling by invitationObservational study
The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
Clinical Efficacy and Safety
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Eravacycline and Pharmacokinetics, run by Sichuan Provincial People's Hospital.
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 5 inclusion and 4 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Lingai Pan (+8617708130236, panlingai2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: At the end of treatment；2 weeks（estimated）). The study lists 2 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 4 Nov 2024.