NCT02795091

Brief Summary

Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated with age, organ dysfunction, invasive treatment and enviroment cleaning. According to hospital hygienic standard for disinfection, total numbers of colony of air and the object surface in ICU must be ≤4CFU/cm2(5min)and≤10CFU/cm2. in this study, the two different methods will be used to evaluate the disinfection effects in ICU enviroments.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

June 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 5, 2016

Last Update Submit

June 10, 2016

Conditions

Keywords

clean suppliesICU floorbacteria colonycatheter associated with infection

Outcome Measures

Primary Outcomes (1)

  • incidence of infection

    up to one month

Secondary Outcomes (1)

  • dose of antibiotics

    up to one month

Study Arms (2)

Manual clean

OTHER

clean the rag and floor towel manually

Other: manual cleaning

machine clean

OTHER

clean the rag and floor towel by machine

Device: machine clean

Interventions

manual clean the rag and floor towel

Manual clean

machine clean the rag and floor towel

machine clean

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no patients recruitment

You may not qualify if:

  • no patients recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 5, 2016

First Posted

June 9, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 13, 2016

Record last verified: 2016-06