High-dose BiapenemNCT04552444
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
An observational study of High-dose Biapenem, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- High-dose Biapenem
- What is being tested?
- Biapenem
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Aug 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Most of the patients were from the coastal areas of the Yangtze River, and some of them were exposed to all parts of the country.
Who may be able to join
- ICU hospitalized for more than 3 days;
- Biapenem used for more than 3 days
Who cannot join
- Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Please Select, 310000
Man Huang, +8613685753994, deter_leung@zju.edu.cn
About this study
Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.
- Conditions
- High-dose Biapenem
- Being tested
- Biapenem
- Keywords
- High-dose Biapenem, Carbapenem resistance Klebsiella pneumoniae, Clinical Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiapenemDrug
In the course of CRKP treatment, double dose biapenem was selected.
| Study group | Role | What they receive |
|---|---|---|
| the death group | Through the corresponding treatment, the patients who died within 28 days Receives: Drug: Biapenem | |
| the survival group | Through the corresponding treatment, the patients who survived within 28 days Receives: Drug: Biapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: 2017.01.01-2021.12.31
Secondary outcomes (2)
Clearance rate of pathogenic microorganisms
Measured: 2017.01.01-2021.12.31
ICU hospitalization days
Measured: 2017.01.01-2021.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Jun 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-dose BiapenemStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Huang, Ph.D, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552444
- Sponsor's protocol ID
- SAHZU2017087
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
- ClinicalTrials.gov ID
- NCT04552444
- Acronym / sponsor ID
- SAHZU2017087
- Conditions
- High-dose Biapenem
- Keywords
- High-dose Biapenem, Carbapenem resistance Klebsiella pneumoniae, Clinical Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 17 Sep 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.
Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the death group | – | Drug: BiapenemThrough the corresponding treatment, the patients who died within 28 days |
| the survival group | – | Drug: BiapenemThrough the corresponding treatment, the patients who survived within 28 days |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Most of the patients were from the coastal areas of the Yangtze River, and some of them were exposed to all parts of the country.
Key inclusion criteria (2 listed)
- ICU hospitalized for more than 3 days;
- Biapenem used for more than 3 days
Key exclusion criteria (1 listed)
- Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days
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 |
|---|---|---|
| BiapenemIn the course of CRKP treatment, double dose biapenem was selected. | Drug | the death group, the survival group |
Primary outcome
28-day mortality
Time frame: 2017.01.01-2021.12.31
2 secondary outcomes
Clearance rate of pathogenic microorganisms
Time frame: 2017.01.01-2021.12.31
ICU hospitalization days
Time frame: 2017.01.01-2021.12.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
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 High-dose Biapenem, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 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 17 Sep 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 Man Huang, Ph D (+8613685753994, deter_leung@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 2017.01.01-2021.12.31). 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 17 Sep 2020.