Klebsiella Pneumoniae InfectionNCT03245632
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China
An observational study of Klebsiella Pneumoniae Infection, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Klebsiella Pneumoniae Infection
- What is being tested?
- Carbapenem-Resistant Klebsiella pneumoniae
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Aug 2017to Dec 2019
- How long will I take part?
- 2 Months
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted to all study hospitals and met the aboved eligibility
Who may be able to join
- new confirmed noscomial infection of CRKP
Who cannot join
- Age<18, or >85 years old; Mixed infection of CRKP and other microbes
Trial locations and contacts
1 site in 1 country.
About this study
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.
Read the detailed description
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection
- Conditions
- Klebsiella Pneumoniae Infection
- Being tested
- Carbapenem-Resistant Klebsiella pneumoniae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbapenem-Resistant Klebsiella pneumoniaeOther
no intervention, this is an obervational study.
| Study group | Role | What they receive |
|---|---|---|
| Carbapenem-Resistant K. pneumoniae | Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection. Receives: Other: Carbapenem-Resistant Klebsiella pneumoniae | |
| Carbapenem-Sensitive K. pneumoniae | Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRKP infection
Culture postitive results confirmed the infection of CRKP
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klebsiella Pneumoniae InfectionStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
- Investigators
- Yun-song YU, Doctor, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245632
- Sponsor's protocol ID
- SRRSH-CRKP
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For the time, we are not yet make determined to take the IPD plan
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China
- ClinicalTrials.gov ID
- NCT03245632
- Acronym / sponsor ID
- SRRSH-CRKP
- Conditions
- Klebsiella Pneumoniae Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Aug 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.
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.
Detailed description
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbapenem-Resistant K. pneumoniae | – | Other: Carbapenem-Resistant Klebsiella pneumoniaePatients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection. |
| Carbapenem-Sensitive K. pneumoniae | – | –Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to all study hospitals and met the aboved eligibility
Key inclusion criteria (1 listed)
- new confirmed noscomial infection of CRKP
Key exclusion criteria (1 listed)
- Age<18, or >85 years old; Mixed infection of CRKP and other microbes
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 |
|---|---|---|
| Carbapenem-Resistant Klebsiella pneumoniaeno intervention, this is an obervational study. | Other | Carbapenem-Resistant K. pneumoniae |
Primary outcome
CRKP infection
Time frame: 7 days
Culture postitive results confirmed the infection of CRKP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Individual participant dataSharing planned: Undecided. For the time, we are not yet make determined to take the IPD plan
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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.
Yun-song YU, Doctor principal investigator
Sir Run Run Shaw 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 Klebsiella Pneumoniae Infection, run by Sir Run Run Shaw 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 1 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 10 Aug 2017. 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 Ying-zhi FANG, Master (+86 57186006811, fyz4817@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRKP infection (time frame: 7 days). 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 10 Aug 2017.