NCT02886637

Brief Summary

The purpose of the present study is to evaluate the effects of immune function on prognositic outcome in critical ill patients with Acinetobacter baumannii infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Status
completed

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

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 27, 2016

Last Update Submit

August 31, 2016

Conditions

Acinetobacter Baumannii Infection

Keywords

A baumannii infectionImmunosuppressionprognosisimmune function

Outcome Measures

Primary Outcomes (1)

  • 28 day mortality

    28 day

Study Arms (1)

Acinetobacter baumannii infection

Critically ill patients infect with Acinetobacter baumannii

Other: None intervention

Interventions

None interventionOTHER
Acinetobacter baumannii infection

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who admitted into ICU and infection with Acinetobacter baumannii.

You may qualify if:

  • Patients admitted to ICU
  • Infection with Acinetobacter baumannii
  • Agree to participate the study

You may not qualify if:

  • Age less than 16 years old or older than 80 years old
  • pregnancy
  • immunosuppression patients which include
  • therapy 0.5mg/kg/day of prednisoneover(equivalent dose of other glucocorticoids) for at least 1 month within recent 3 month
  • Cancer chemotherapy within recent 3 month
  • Receive immunosuppression treatment because of solid organ transplant or Autoimmune diseases
  • allogeneic bone marrow transplantation or allogeneic haematopoietic stem cell transplantation.
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 1, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

we would like to share our data. Someone who need data can contact us with Email.