Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or OthersNCT03333863
Bacterial and Antimicrobial Susceptibility Profile and the Prevalence of Different Sites of Infection(BASPP)
An observational study of Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or Others and Positive Bacterial Cultures Results of the Medical Records, run by Shengjing Hospital at 1 site in China.
Trial summary
Positive results of bacterial culture are analyzed comprehensively in Shengjing Hospital of China Medical University in recent 3 years（between 2015- 2017） Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or Others, Positive Bacterial Cultures Results of the Medical Records
- What is being tested?
- descriptive study which reviewed the data of patients hospitalized with positive bacterial cultures
- How many people
- 1,889 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2017to 31 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized with positive bacterial cultures results in blood, urine, sputum, and secretion, are enrolled at shengjing hospital of China Medical University from January 2015 to December 2017.
Who may be able to join
- Clinical diagnosis of pneumonia, nephropyelitis, angiocholitis or other infectious diseases
- Positive results of bacterial cultures in blood, urine, sputum, and secretion
- The medical records of shengjing hospital of China Medical University from January 2015 to December 2017
Who cannot join
- Negative results of bacterial cultures in blood, urine, sputum, and secretion
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Bacterial and Antimicrobial Susceptibility Profile and the Prevalence of Different Sites of Infection in Shengjing Hospital of China Medical University: a Retrospective, Descriptive Study
Positive results of bacterial culture are analyzed comprehensively in Shengjing Hospital of China Medical University in recent 3 years（between 2015- 2017）
- Conditions
- Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or Others, Positive Bacterial Cultures Results of the Medical Records
- Being tested
- descriptive study which reviewed the data of patients hospitalized with positive bacterial cultures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptive study which reviewed the data of patients hospitalized with positive bacterial culturesOther
A retrospective, descriptive study was conducted at shengjing hospital of China Medical University between 2015- 2017. Data regarding bacterial culture isolates, antimicrobial susceptibility spectrum, and the general data of patients with fever or suspicion of sepsis were collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial and antimicrobial susceptibility profile
Primary outcome was recording the results of bacterial and antimicrobial susceptibility profile of pneumonia, nephropyelitis, or angiocholitis, measured with statistical methods.
Measured: From January 2015 to December 2017
Secondary outcomes (1)
patient's critical condition
Secondary outcome was evaluating the patient's critical condition, measured with APACHE (acute physiology and chronic health evaluation) II score.
Measured: From January 2015 to December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start25 Oct 2017
- Primary completion30 Jun 2018
- Study completion31 Oct 2019
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 Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or OthersStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Retrospective
- Enrolment
- 1,889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Zhao, Shengjing Hospital
- Investigators
- Hongyu Zhao, doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333863
- Sponsor's protocol ID
- BASPP
- Status last verified
- May 2020
- First submitted
- 28 Oct 2017
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Musicha P, Cornick JE, Bar-Zeev N, French N, Masesa C, Denis B, Kennedy N, Mallewa J, Gordon MA, Msefula CL, Heyderman RS, Everett DB, Feasey NA. Trends in antimicrobial resistance in bloodstream infection isolates at a large urban hospital in Malawi (1998-2016): a surveillance study. Lancet Infect Dis. 2017 Oct;17(10):1042-1052. doi: 10.1016/S1473-3099(17)30394-8. Epub 2017 Aug 14.
PubMed 28818544
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial and Antimicrobial Susceptibility Profile and the Prevalence of Different Sites of Infection in Shengjing Hospital of China Medical University: a Retrospective, Descriptive Study
- ClinicalTrials.gov ID
- NCT03333863
- Acronym / sponsor ID
- BASPP
- Conditions
- Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or Others, Positive Bacterial Cultures Results of the Medical Records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,889 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 7 Nov 2017 (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.
Positive results of bacterial culture are analyzed comprehensively in Shengjing Hospital of China Medical University in recent 3 years（between 2015- 2017）
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized with positive bacterial cultures results in blood, urine, sputum, and secretion, are enrolled at shengjing hospital of China Medical University from January 2015 to December 2017.
Key inclusion criteria (3 listed)
- Clinical diagnosis of pneumonia, nephropyelitis, angiocholitis or other infectious diseases
- Positive results of bacterial cultures in blood, urine, sputum, and secretion
- The medical records of shengjing hospital of China Medical University from January 2015 to December 2017
Key exclusion criteria (1 listed)
- Negative results of bacterial cultures in blood, urine, sputum, and secretion
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 |
|---|---|---|
| descriptive study which reviewed the data of patients hospitalized with positive bacterial culturesA retrospective, descriptive study was conducted at shengjing hospital of China Medical University between 2015- 2017. Data regarding bacterial culture isolates, antimicrobial susceptibility spectrum, and the general data of patients with fever or suspicion of sepsis were collected. | Other | – |
Primary outcome
bacterial and antimicrobial susceptibility profile
Time frame: From January 2015 to December 2017
Primary outcome was recording the results of bacterial and antimicrobial susceptibility profile of pneumonia, nephropyelitis, or angiocholitis, measured with statistical methods.
1 secondary outcome
patient's critical condition
Time frame: From January 2015 to December 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 28818544Musicha P, Cornick JE, Bar-Zeev N, French N, Masesa C, Denis B, Kennedy N, Mallewa J, Gordon MA, Msefula CL, Heyderman RS, Everett DB, Feasey NA. Trends in antimicrobial resistance in bloodstream infection isolates at a large urban hospital in Malawi (1998-2016): a surveillance study. Lancet Infect Dis. 2017 Oct;17(10):1042-1052. doi: 10.1016/S1473-3099(17)30394-8. Epub 2017 Aug 14.
- Individual participant dataSharing planned: No
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.
Hongyu Zhao, doctor principal investigator
Shengjing 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 Infectious Diseases in Pneumonia,Nephropyelitis,Angiocholitis or Others and Positive Bacterial Cultures Results of the Medical Records, run by Shengjing 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 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: finished, as of the sponsor's last update on 19 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial and antimicrobial susceptibility profile (time frame: From January 2015 to December 2017). 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 NCT03333863, 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 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.