ABOUT THIS STUDY
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1. Gram-negative bacillus.
2. Resistant to more than 3 kinds of antibacterial agents.
1. Repetitive organism isolated from the same center in one patient.
2. Judged as colonization or pollution by clinician.
3. Enrolled into other trial, and the data is not available for the current study.
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Descriptive Information | |||||||
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Brief Title | MDR Bacilli Surveillance and Clinical Feature in China | ||||||
Official Title | Multi-drug Resistant Gram-negative Bacilli-surveillance and Clinical Feature in China | ||||||
Brief Summary | Objective
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Detailed Description |
Statistical analysis is conducted by t-test for continuous variables and chi-square test for categorical variables. Multivariate regression analysis, Logistic regression model is used to clarify the independent risk factors of infection and death. All p values are retained until after the decimal point two, and statistical significance was set at p <0.05. | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples Without DNA Description: sputum, pleural effusion or blood | ||||||
Sampling Method | Probability Sample | ||||||
Study Population | 3000 | ||||||
Condition | Infection | ||||||
Intervention | Not Provided | ||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment | 1500 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | December 2015 | ||||||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT02140853 | ||||||
Other Study ID Numbers | WS1993136 MDR Net ( Other Grant/Funding Number: Pfizer, WI1993136 ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Prof Xie Canmao, Sun Yat-sen University | ||||||
Study Sponsor | Sun Yat-sen University | ||||||
Collaborators | Pfizer | ||||||
Investigators |
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PRS Account | Sun Yat-sen University | ||||||
Verification Date | May 2014 |