Bacterial InfectionNCT02931526
Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)
An observational study of Bacterial Infection and Critically Ill, run by Zhujiang Hospital at 1 site in China.
Trial summary
The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bacterial Infection, Critically Ill
- What is being tested?
- Tigecycline
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2017
- 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: Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives
Who may be able to join
- Aged 18-75 years,hospitalized ICU patients, male or female;
- having definitive diagnosis to treat with tigecycline for bacterial infection;
- receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.
Who cannot join
- Patients with Child-Pugh C cirrhosis;
- Allergic to tetracycline or tigecycline;
- Patients received CRRT for < 3 days or treated with tigecycline < 3 days;
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
Wang Liqing, doctor, +86-02061643555, wliqing2014@163.com
About this study
Official title: Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy
The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.
The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.
- Conditions
- Bacterial Infection, Critically Ill
- Being tested
- Tigecycline
- Keywords
- Tigecycline, Continuous Renal Replacement Therapy, Pharmacokinetics
- Medical subject headings
- Bacterial Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
Also called Tygacil
Patients who have the definitive diagnosis to treat with tigecycline for bacterial infection will be started on tigecycline with a loading dose 200mg IV followed by 100mg IV every 12h.
| Study group | Role | What they receive |
|---|---|---|
| Group CRRT | Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT Receives: Drug: Tigecycline | |
| Group non-CRRT | Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT Receives: Drug: Tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tigecycline Steady State Plasma Concentrations
Steady State Plasma Concentration(Css) in blood
Measured: Day 1-3
Secondary outcomes (4)
Peak Plasma Concentration(Cmax) of Tigecycline in blood
Measured: Day 1-3
Trough Plasma Concentration(Cmin) of Tigecycline in blood
Measured: Day 1-3
Area Under the Plasma Concentration versus Time Curve(AUC)
Measured: Day 1-3
Minimal Inhibitory Concentration(MIC)
Measured: Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Liqing, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931526
- Sponsor's protocol ID
- LCYJ1
- Status last verified
- Jul 2016
- First submitted
- 19 Sep 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669.
PubMed 32716292
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02931526
- Acronym / sponsor ID
- LCYJ1
- Conditions
- Bacterial Infection, Critically Ill
- Keywords
- Tigecycline, Continuous Renal Replacement Therapy, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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 determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.
The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CRRT | – | Drug: TigecyclinePatients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT |
| Group non-CRRT | – | Drug: TigecyclinePatients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives
Key inclusion criteria (3 listed)
- Aged 18-75 years,hospitalized ICU patients, male or female;
- having definitive diagnosis to treat with tigecycline for bacterial infection;
- receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.
Key exclusion criteria (4 listed)
- Patients with Child-Pugh C cirrhosis;
- Allergic to tetracycline or tigecycline;
- Patients received CRRT for < 3 days or treated with tigecycline < 3 days;
- Patients who are pregnant.
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 |
|---|---|---|
| TigecyclineAlso: TygacilPatients who have the definitive diagnosis to treat with tigecycline for bacterial infection will be started on tigecycline with a loading dose 200mg IV followed by 100mg IV every 12h. | Drug | Group CRRT, Group non-CRRT |
Primary outcome
Tigecycline Steady State Plasma Concentrations
Time frame: Day 1-3
Steady State Plasma Concentration(Css) in blood
4 secondary outcomes
Peak Plasma Concentration(Cmax) of Tigecycline in blood
Time frame: Day 1-3
Trough Plasma Concentration(Cmin) of Tigecycline in blood
Time frame: Day 1-3
Area Under the Plasma Concentration versus Time Curve(AUC)
Time frame: Day 1-3
Minimal Inhibitory Concentration(MIC)
Time frame: Day 1-3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 32716292Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669.
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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.
Wang Liqing, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
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 Bacterial Infection and Critically Ill, run by Zhujiang 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 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 13 Oct 2016. 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 Wang Liqing, Doctor (+86-02061643555, wliqing2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tigecycline Steady State Plasma Concentrations (time frame: Day 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931526, which also lists 1 linked publication.
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 Oct 2016.