NCT02414581

Brief Summary

Clinical triple-blind randomized controlled trial to assess the use of two different mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with chemotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 25, 2018

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

April 3, 2015

Last Update Submit

May 23, 2018

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

  • Rate of oral colonization by gram-negative bacteria

    10 days

Secondary Outcomes (3)

  • Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.

    Baseline

  • Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm

    10 days

  • Number of participants with presence of severe neutropenia and fever in each study group.

    10 days

Study Arms (3)

Chlorhexidine 0.12% & Ethyl Alcohol 7%

EXPERIMENTAL

Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.

Drug: chlorhexidine 0.12%/Ethyl alcohol 7%

Ethyl Alcohol 7%

ACTIVE COMPARATOR

Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.

Drug: Ethyl Alcohol 7%

Chlorhexidine 2% & Ethyl Alcohol 7%

EXPERIMENTAL

Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.

Drug: Chlorhexidine 2%/Ethyl alcohol 7%

Interventions

chlorhexidine 0.12%/Ethyl alcohol 7%DRUG

Mouth rinses with chlorhexidine 0.12%-based solution

Chlorhexidine 0.12% & Ethyl Alcohol 7%
Ethyl Alcohol 7%DRUG

Mouth rinses with Ethyl Alcohol 7%-based solution

Ethyl Alcohol 7%
Chlorhexidine 2%/Ethyl alcohol 7%DRUG

Mouth rinses with chlorhexidine 2%-based solution

Chlorhexidine 2% & Ethyl Alcohol 7%

Eligibility Criteria

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

You may qualify if:

  • Patients over 18years, no upper age limit.
  • Acceptance of participation in the study.
  • Signature of informed consent.
  • Inpatient and remain hospitalized for at least 10 days.
  • The following haematological diagnosis:
  • acute lymphoblastic leukemia.
  • acute myelogenous leukemia.
  • relapsed non-Hodgkin lymphoma.
  • Receiving Chemotherapy scheme as a treatment for the underlying disease

You may not qualify if:

  • Patients who choose not to participate in the study.
  • Patients in whom no possible mouthwashes.
  • Patients who willingly choose to withdraw from the study.
  • Patients who develop conditions in which the administration is not possible rinses.
  • Duration of hospital stay less than 10 days, regardless of cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional Alta Especialidad Bajio

León, Guanajuato, 37660, Mexico

Location

Related Publications (1)

  • Pitten FA, Kiefer T, Buth C, Doelken G, Kramer A. Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. J Hosp Infect. 2003 Apr;53(4):283-91. doi: 10.1053/jhin.2002.1391.

    PMID: 12660125RESULT

MeSH Terms

Conditions

Neutropenia

Interventions

ChlorhexidineEthanol

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsAlcohols

Study Officials

  • Lauro F Amador, Researcher

    Hospital Regional Alta Especialidad Bajio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 10, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

May 25, 2018

Record last verified: 2016-09

Locations

ME(1)