NCT01361997

Brief Summary

The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,102

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

May 23, 2011

Last Update Submit

August 17, 2016

Conditions

Infectious Diseases

Keywords

AntisepticsHemoculture contaminationAnti-infecting agents, local

Outcome Measures

Primary Outcomes (1)

  • Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.

    It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.

    120 hours

Secondary Outcomes (2)

  • Determine the rate of contamination of each antiseptic used.

    1 year

  • Description of the most frequent bacterial contaminants.

    1 year

Study Arms (2)

Chlorhexidine in isopropyl alcohol

EXPERIMENTAL

This arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol.

Biological: chlorhexidine in isopropyl alcohol

Isopropyl alcohol

EXPERIMENTAL

This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.

Biological: Isopropyl alcohol

Interventions

chlorhexidine in isopropyl alcoholBIOLOGICAL

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Also known as: Chloraprep, Enturia Inc., Texas., BacT/ALERT FA, Biomérieux Inc., North Carolina.
Chlorhexidine in isopropyl alcohol
Isopropyl alcoholBIOLOGICAL

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Also known as: Alcohol Swabs, BD, Madrid., BacT/ALERT FA, Biomérieux Inc., North Carolina.
Isopropyl alcohol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected blood stream infection.
  • Patients allocated in admission, hospitalization and intensive care units.

You may not qualify if:

  • Patients with a single peripheral hemoculture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Chlorhexidine2-PropanolEthanol

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPropanolsAlcohols

Study Officials

  • Alejandro E. Macias, M. D.

    Universidad de Guanajuato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-time professor

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 27, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 19, 2016

Record last verified: 2012-08

Locations

ME(1)