AntibioticNCT04546815
The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection.
An observational study of Antibiotic, run by Jiangsu Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to collect and analyze clinical data of daptomycin to explore the efficacy and safety of daptomycin in the treatment of Gram-positive bacterial infections. And optimize the dosing regimen based on these data. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Antibiotic
- What is being tested?
- Daptomycin
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2020to Aug 2022
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study plans to recruit 2000 patients infected with gram-positive bacteria.
Who may be able to join
- 1 years of age or older
- Meet one of the following conditions:
- Confirmed Gram-positive cocci (GPC) infection;
- Cases evaluated by doctors as suspected gram-positive coccal infection with potentially high benefit from drug use；
- Severe infection patients to be combined with empirical treatment of daptomycin.
- The off-label drug use conforms to the relevant administrative regulations of each participating unit.
Who cannot join
- Allergic to datoramycin;
- Pregnant and lactating women；
- Patients with age < 1 year；
- Participate in other clinical trials；
- Patients with nervous system GPC infection;
- Patients with pulmonary GPC infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
XiaoJun X Ma, doctor, +86 13911378823 ext. 13911378823, xjma@public.bta.net.cn
Jun J Ren, master, +86 18205138967 ext. 18205138967, renjun8967@163.com
About this study
Official title: Non-interventional Observational Study of Daptomycin in the Treatment of Gram-positive Bacterial Infections
This study aims to collect and analyze clinical data of daptomycin to explore the efficacy and safety of daptomycin in the treatment of Gram-positive bacterial infections. And optimize the dosing regimen based on these data.
Read the detailed description
With the gradual increase in the detection rate of drug-resistant bacteria, bloodstream infections, skin and soft tissue infections, infective endocarditis and other infectious diseases caused by MRSA, MRCNS, and VRE have greatly increased patient mortality and medical burden.
Daptomycin has strong anti-bacterial activity and rapid sterilization. It is almost 100% sensitive to common Gram-positive bacteria. Both domestic and foreign guidelines recommend its use for the treatment of infectious diseases such as bacteremia, central venous catheter-related bloodstream infections, infective endocarditis, skin and soft tissue infections, bone and joint infections，and so on. However, there is a lack of actual clinical use of daptomycin in China, as well as efficacy and safety assessments based on real world data.
The purpose of this study is to collect and analyze data on the use of daptomycin in the real world. The clinical cure rate and inefficiency, temperature drop time, 28-day mortality rate are the primary outcome measures, and the overall incidence of adverse events, the results of CPK monitoring and its correlation with dose, renal function, length of hospital stay, and treatment costs are secondary outcome measures to investigate the efficacy and safety of daptomycin in the treatment of gram-positive bacterial infection.
- Conditions
- Antibiotic
- Being tested
- Daptomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.
| Study group | Role | What they receive |
|---|---|---|
| Gram-positive cocci infection | No intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed. Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy rate
Clinical efficacy includes clinical cure and clinical improvement.
Measured: 1 day of the end of treatment
Clinical cure rate
Clinical cure was defined as that after the end of treatment, all the selected symptoms and signs had disappeared or completely returned to normal, and all the non-microbiological indicators, such as imaging and laboratory examination, had returned to normal.
Measured: 14 days of the end of treatment
Treatment failure rate
Treatment failure includes one of the following conditions:
- After the end of the treatment, all the symptoms and signs of the patients at the time of inclusion continued or worsened.
- Recurrence.
- Termination of treatment due to adverse reactions.
Measured: 28 days of the end of treatment
Time for body temperature to return to normal.
During the use of daptomycin, take body temperature records.
Measured: 14 days of the end of treatment
28-Day Mortality Rate
Record the number of deaths 28 days after the end of treatment
Measured: 28 days of the end of treatment
Secondary outcomes (4)
Bacteria clearance rate (if available, such as bacteremia)
Bacterial clearance includes clearance and hypothetical clearance. Bacterial clearance is defined as the specimens from the original infection site after treatment have not cultivated the pathogenic bacteria of the original infection.
When the patient's symptoms and signs disappear so that cultivable materials cannot be obtained, or the method of obtaining specimens is too invasive for the recovered patient, the bacteriological result is considered to be a hypothetical clearance.
Measured: 1 day of the end of treatment
The overall incidence of adverse events
Adverse events refer to adverse medical events that occur after patients or clinical trial subjects receive a drug, but they do not necessarily have a causal relationship with treatment.
Measured: 14 days of the end of treatment
Monitor creatine phosphokinase（CPK） levels
Record the CPK monitoring results.
Measured: 14 days of the end of treatment
hospital stays
Measured: 28 days of the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start25 Aug 2020
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XiaoJun X Ma, doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546815
- Sponsor's protocol ID
- SINGCHN-DAP-IV-2002
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.
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
- Non-interventional Observational Study of Daptomycin in the Treatment of Gram-positive Bacterial Infections
- ClinicalTrials.gov ID
- NCT04546815
- Acronym / sponsor ID
- SINGCHN-DAP-IV-2002
- Conditions
- Antibiotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Jiangsu Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 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.
This study aims to collect and analyze clinical data of daptomycin to explore the efficacy and safety of daptomycin in the treatment of Gram-positive bacterial infections. And optimize the dosing regimen based on these data.
Detailed description
With the gradual increase in the detection rate of drug-resistant bacteria, bloodstream infections, skin and soft tissue infections, infective endocarditis and other infectious diseases caused by MRSA, MRCNS, and VRE have greatly increased patient mortality and medical burden.
Daptomycin has strong anti-bacterial activity and rapid sterilization. It is almost 100% sensitive to common Gram-positive bacteria. Both domestic and foreign guidelines recommend its use for the treatment of infectious diseases such as bacteremia, central venous catheter-related bloodstream infections, infective endocarditis, skin and soft tissue infections, bone and joint infections，and so on. However, there is a lack of actual clinical use of daptomycin in China, as well as efficacy and safety assessments based on real world data.
The purpose of this study is to collect and analyze data on the use of daptomycin in the real world. The clinical cure rate and inefficiency, temperature drop time, 28-day mortality rate are the primary outcome measures, and the overall incidence of adverse events, the results of CPK monitoring and its correlation with dose, renal function, length of hospital stay, and treatment costs are secondary outcome measures to investigate the efficacy and safety of daptomycin in the treatment of gram-positive bacterial infection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gram-positive cocci infection | – | Drug: DaptomycinNo intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study plans to recruit 2000 patients infected with gram-positive bacteria.
Key inclusion criteria (6 listed)
- 1 years of age or older
- Meet one of the following conditions:
- The off-label drug use conforms to the relevant administrative regulations of each participating unit.
Key exclusion criteria (6 listed)
- Allergic to datoramycin;
- Pregnant and lactating women；
- Patients with age < 1 year；
- Participate in other clinical trials；
- Patients with nervous system GPC infection;
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 |
|---|---|---|
| DaptomycinAccording to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin. | Drug | Gram-positive cocci infection |
Primary outcome
Clinical efficacy rate
Time frame: 1 day of the end of treatment
Clinical efficacy includes clinical cure and clinical improvement.
Clinical cure rate
Time frame: 14 days of the end of treatment
Clinical cure was defined as that after the end of treatment, all the selected symptoms and signs had disappeared or completely returned to normal, and all the non-microbiological indicators, such as imaging and laboratory examination, had returned to normal.
Treatment failure rate
Time frame: 28 days of the end of treatment
Treatment failure includes one of the following conditions: 1. After the end of the treatment, all the symptoms and signs of the patients at the time of inclusion continued or worsened. 2. Recurrence. 3. Termination of treatment due to adverse reactions.
Time for body temperature to return to normal.
Time frame: 14 days of the end of treatment
During the use of daptomycin, take body temperature records.
28-Day Mortality Rate
Time frame: 28 days of the end of treatment
Record the number of deaths 28 days after the end of treatment
4 secondary outcomes
Bacteria clearance rate (if available, such as bacteremia)
Time frame: 1 day of the end of treatment
The overall incidence of adverse events
Time frame: 14 days of the end of treatment
Monitor creatine phosphokinase（CPK） levels
Time frame: 14 days of the end of treatment
hospital stays
Time frame: 28 days of the end of treatment
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: No. The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.
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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.
XiaoJun X Ma, doctor principal investigator
Peking Union Medical College Hospital
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 Antibiotic, run by Jiangsu Hengrui Pharmaceutical Co., Ltd. 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 6 inclusion and 6 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 Jun J Ren, master (18205138967 ext. 18205138967, renjun8967@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy rate (time frame: 1 day of the end of treatment). The study lists 5 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 17 Sep 2020.