NCT02140853

Brief Summary

Objective

  1. 1.To evaluate the impact of MDR pathogen on prognosis and therapy cost;
  2. 2.To compare the efficacy of different antibiotics in treatment of infection caused by MDR pathogens;
  3. 3.To evaluate the risk factors of MDR pathogens infection;
  4. 4.To evaluate the distribution and characteristics of MDR pathogens;
  5. 5.To investigate the proportion of MDR isolates to construct systematic database.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

3.1 years

First QC Date

May 14, 2014

Last Update Submit

May 14, 2014

Conditions

Infection

Keywords

MDR gram-negative bacilliMortalityTherapy

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality comparizon between MDR or non-MDR infection

    Jun 2015

Secondary Outcomes (1)

  • Therapy cost

    Jun 2015

Other Outcomes (1)

  • Success rate of different antibiotics regimen for treatment of MDR infection

    Jun 2015

Study Arms (2)

MDR group

patients of MDR pathogen infection

non-MDR group

patients of non-MDR pathogen infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

3000

You may qualify if:

  • Gram-negative bacillus.
  • Resistant to more than 3 kinds of antibacterial agents.

You may not qualify if:

  • Repetitive organism isolated from the same center in one patient.
  • Judged as colonization or pollution by clinician.
  • Enrolled into other trial, and the data is not available for the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum, pleural effusion or blood

MeSH Terms

Conditions

Infections

Study Officials

  • Canmao Xie, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yuxing Ni, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Canmao Xie, MD

CONTACT

xiecanmao@163.com

Yuxing Ni, MD

CONTACT

yuxing_ni@yahoo.com.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Respiratory Department

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

CN(1)