TigecyclineNCT04970537
Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection
An observational study of Tigecycline and Polymyxin B, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Tigecycline, Polymyxin B, Intensive Care Unit
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2017to 31 Jul 2021
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 14-95 year-old patients in ICU, who received tigecycline and polymyxin B treatment (≥4d).
Who may be able to join
- ICU patients receiving tigecycline or polymyxin B treatment;
- Age 14-95, gender unlimited;
- there are clear infections and strains;
- The patient and/or his/her family agree to sign the informed consent voluntarily.
Who cannot join
- Patients with treatment of less than 4 days;
- patients with abscission;
- Pregnant patients;
- Patients with age < 14 years or > 95 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central south university
Changsha, Hunan
Shuangping Zhao, 13974953002, zsping8888@sina.cn
About this study
The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included.
To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis.
Read the detailed description
The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included. The four hospitals included the 1st-3th XiangYa Hospitals and Hunan Provincial People's Hospital. Organize the data.Patients with a course of treatment < 4 days and shedding were excluded.To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis. The chi-square test was used for the counting data, and the Mann-Whitney U test or Kruskal-Wallis H test was used for the measurement data. The significance value was adjusted by Bonferroni correction method for multiple tests, and the P was tested on both sides,P>0.05.
- Conditions
- Tigecycline, Polymyxin B, Intensive Care Unit
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality rate
Patients die in hospital or abandon treatment due to poor prognosis in hospital after treatment of tigecycline or polymyxin B
Measured: up to hospital discharge or die in hospital, up to 48 weeks(estimation).
30d mortality rate
Patients die after treatment of tigecycline or polymyxin B
Measured: up to the 30th day of the treatment of tigecycline or polymyxin B
Bacterial clearance rate
Bacterial clearance during treatment of tigecycline or polymyxin B
Measured: from the first day of the treatment of tigecycline or polymyxin B until to the end day, up to 8 weeks (estimation).
Secondary outcomes (6)
The length of hospital stay
The length of hospital stay,days
Measured: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
The length of ICU stay
The length of ICU stay
Measured: up to hospital discharge or die in hospital, up to 24 weeks (estimation).
Hospitalization Cost
total Hospitalization Cost
Measured: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
serum creatinine
serum creatinine at the end day of the treatment of tigecycline or polymyxin B
Measured: at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).
MV days
the total days with mechanical ventilation
Measured: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
VA days
the total days with vasoactive agent
Measured: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start23 Jul 2017
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TigecyclineStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuangping Zhao, Study chair, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970537
- Sponsor's protocol ID
- 202105202
- Status last verified
- Aug 2020
- First submitted
- 4 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection
- ClinicalTrials.gov ID
- NCT04970537
- Acronym / sponsor ID
- 202105202
- Conditions
- Tigecycline, Polymyxin B, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 23 Jul 2017 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 21 Jul 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 gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included.
To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis.
Detailed description
The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included. The four hospitals included the 1st-3th XiangYa Hospitals and Hunan Provincial People's Hospital. Organize the data.Patients with a course of treatment < 4 days and shedding were excluded.To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis. The chi-square test was used for the counting data, and the Mann-Whitney U test or Kruskal-Wallis H test was used for the measurement data. The significance value was adjusted by Bonferroni correction method for multiple tests, and the P was tested on both sides,P>0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 14-95 year-old patients in ICU, who received tigecycline and polymyxin B treatment (≥4d).
Key inclusion criteria (4 listed)
- ICU patients receiving tigecycline or polymyxin B treatment;
- Age 14-95, gender unlimited;
- there are clear infections and strains;
- The patient and/or his/her family agree to sign the informed consent voluntarily.
Key exclusion criteria (4 listed)
- Patients with treatment of less than 4 days;
- patients with abscission;
- Pregnant patients;
- Patients with age < 14 years or > 95 years.
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
hospital mortality rate
Time frame: up to hospital discharge or die in hospital, up to 48 weeks(estimation).
Patients die in hospital or abandon treatment due to poor prognosis in hospital after treatment of tigecycline or polymyxin B
30d mortality rate
Time frame: up to the 30th day of the treatment of tigecycline or polymyxin B
Patients die after treatment of tigecycline or polymyxin B
Bacterial clearance rate
Time frame: from the first day of the treatment of tigecycline or polymyxin B until to the end day, up to 8 weeks (estimation).
Bacterial clearance during treatment of tigecycline or polymyxin B
6 secondary outcomes
The length of hospital stay
Time frame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
The length of ICU stay
Time frame: up to hospital discharge or die in hospital, up to 24 weeks (estimation).
Hospitalization Cost
Time frame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
serum creatinine
Time frame: at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).
MV days
Time frame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
VA days
Time frame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
Related trials for Tigecycline
Not yet recruitingPhase 2
Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria
MDR Bacteria
Enrolling by invitationObservational study
The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
Clinical Efficacy and Safety
Active, not recruitingPhase 4
Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
Multi Drug Resistant Infections
Active, not recruitingPhase 4
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline
Infection in ICU
Not yet recruitingObservational study
Comparing Tigecycline Vs. Colistimethate in CNS Infections
Central Nervous System Infections
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.
Shuangping Zhao study chair
Xiangya Hospital of Central South 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 Tigecycline and Polymyxin B, run by Xiangya Hospital of Central South 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 4 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 21 Jul 2021. 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 Shuangping Zhao (13974953002, zsping8888@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital mortality rate (time frame: up to hospital discharge or die in hospital, up to 48 weeks(estimation).). 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 21 Jul 2021.