AntibioticsNCT04966390
Standardized Clinical Application of Antibacterial/Anitifungal Drugs
An observational study of Antibiotics, run by Peking University People's Hospital.
Trial summary
The purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotics
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2021to 31 Dec 2022
- How long will I take part?
- 3 Weeks
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This research plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease), who use antibacterial/antifungal drugs for more than 3 days. Patients mainly come from ICU, respiratory department and hematology department.
Who may be able to join
- Hospitalized patients (≥ 18 years old)
- -≥ 3 days receiving antibacterial/antifungal drugs therapy
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs
The purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy.
Read the detailed description
This study is a prospective,multicenter,non-interventional real-world study.The purpose of this study is to observe the clinical status of infection patients under standardized application of antibacterial/anitifungal drugs,and to evaluate the efficacy and safety of anti-infection treatment.
This study plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease),who take antibacterial/anitifungal drugs for more than 3 days. Patients mainly come from ICU,Respiratory Department and Hematology Department.
The clinical data collection is divided into five parts,including Baseline,3rd and 7th day after the first dosing of antibacterial/anitifungal drugs,End of antibacterial/anitifungal drugs treatment (EOT),14th day after EOT. The collected clinical data cover general characteristics,condition assessment and severity evaluation,pathogenic diagnosis,the use of antibacterial/antifungal drugs,antibacterial/antifungal drugs-related adverse events,et al.
After completing the collection of case data, the proportion analysis, efficacy evaluation and safety evaluation for the standardized application of antibacterial/antifungal drugs will be carried out.
- Conditions
- Antibiotics
- Keywords
- antibacterial/anitifungal drugs, real world study, standardized treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of standardized using of antibacterial/antifungal drugs
the proportion of cases who receive standardized antibacterial/antifungal drugs therapy
Measured: approximately 6 months after completion of data collection
Clinical efficacy rate
the clinical efficacy evaluation of antibacterial/antifungal drugs therapy
Measured: approximately 6 months after completion of data collection
Secondary outcomes (4)
Microbiological efficacy rate
the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy
Measured: approximately 6 months after completion of data collection
Overall efficacy rate
the overall efficacy evaluation of antibacterial/antifungal drugs therapy based on clinical and microbiological efficacy outcome
Measured: approximately 6 months after completion of data collection
All-cause mortality
the evaluation of all-cause mortality
Measured: approximately 6 months after completion of data collection
Antibacterial/antifungal drugs-Related Adverse Events
only evaluate of the adverse events related to antibacterial/antifungal drugs
Measured: approximately 6 months after completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start20 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (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 AntibioticsStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An Youzhong, Peking University People's Hospital
- Investigators
- Youzhong An, Principal investigator, Peking University People 's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966390
- Sponsor's protocol ID
- ANTI
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang S, Sun Y, Wang T, Hao C, Zhang H, Sun W, An Y, Zhao H. Machine learning-based prediction of mortality and multidrug-resistant infection risks in ICU patients with suspected infection: a prospective national multicenter cohort study. BMC Infect Dis. 2025 Dec 20;26(1):139. doi: 10.1186/s12879-025-12354-8.
PubMed 41422100
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs
- ClinicalTrials.gov ID
- NCT04966390
- Acronym / sponsor ID
- ANTI
- Conditions
- Antibiotics
- Keywords
- antibacterial/anitifungal drugs, real world study, standardized treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 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 purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy.
Detailed description
This study is a prospective,multicenter,non-interventional real-world study.The purpose of this study is to observe the clinical status of infection patients under standardized application of antibacterial/anitifungal drugs,and to evaluate the efficacy and safety of anti-infection treatment.
This study plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease),who take antibacterial/anitifungal drugs for more than 3 days. Patients mainly come from ICU,Respiratory Department and Hematology Department.
The clinical data collection is divided into five parts,including Baseline,3rd and 7th day after the first dosing of antibacterial/anitifungal drugs,End of antibacterial/anitifungal drugs treatment (EOT),14th day after EOT. The collected clinical data cover general characteristics,condition assessment and severity evaluation,pathogenic diagnosis,the use of antibacterial/antifungal drugs,antibacterial/antifungal drugs-related adverse events,et al.
After completing the collection of case data, the proportion analysis, efficacy evaluation and safety evaluation for the standardized application of antibacterial/antifungal drugs will be carried out.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease), who use antibacterial/antifungal drugs for more than 3 days. Patients mainly come from ICU, respiratory department and hematology department.
Key inclusion criteria (2 listed)
- Hospitalized patients (≥ 18 years old)
- -≥ 3 days receiving antibacterial/antifungal drugs therapy
Key exclusion criteria (1 listed)
- -
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
Proportion of standardized using of antibacterial/antifungal drugs
Time frame: approximately 6 months after completion of data collection
the proportion of cases who receive standardized antibacterial/antifungal drugs therapy
Clinical efficacy rate
Time frame: approximately 6 months after completion of data collection
the clinical efficacy evaluation of antibacterial/antifungal drugs therapy
4 secondary outcomes
Microbiological efficacy rate
Time frame: approximately 6 months after completion of data collection
Overall efficacy rate
Time frame: approximately 6 months after completion of data collection
All-cause mortality
Time frame: approximately 6 months after completion of data collection
Antibacterial/antifungal drugs-Related Adverse Events
Time frame: approximately 6 months after completion of data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Derived from this study: PubMed 41422100Yang S, Sun Y, Wang T, Hao C, Zhang H, Sun W, An Y, Zhao H. Machine learning-based prediction of mortality and multidrug-resistant infection risks in ICU patients with suspected infection: a prospective national multicenter cohort study. BMC Infect Dis. 2025 Dec 20;26(1):139. doi: 10.1186/s12879-025-12354-8.
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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.
Youzhong An principal investigator
Peking University People 's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotics, run by Peking University 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 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 19 Jul 2021. 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 Shuguang Yang (+86 13051703401, rwsycb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of standardized using of antibacterial/antifungal drugs (time frame: approximately 6 months after completion of data collection). 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?
On the ClinicalTrials.gov record for NCT04966390, 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 19 Jul 2021.