Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%

Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7% to Reduce the Rate Oral Colonization by Gram-negative Bacteria in Patients With Chemotherapy

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

Study Overview

• Status: Completed
• Conditions: Neutropenia
• Intervention / Treatment: Drug: chlorhexidine 0.12%/Ethyl alcohol 7%; Drug: Ethyl Alcohol 7%; Drug: Chlorhexidine 2%/Ethyl alcohol 7%

Detailed Description

Clinical triple-blind randomized controlled trial.

With two arms to the study:

1. Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
2. Mouthwashes with solution based only 7% ethyl alcohol.

GOAL. Assess whether there decrease in the rate of oral colonization by gram-negative bacteria in patients with chemotherapy by using chlorhexidine mouthwash.

SPECIFIC OBJECTIVES:

1. The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
2. The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
3. Identify microbiologically gram-negative bacteria colonizing the oral cavity.

SECONDARY OBJECTIVES

1. The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37660
      • Hospital Regional Alta Especialidad Bajio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients over 18years, no upper age limit.
2. Acceptance of participation in the study.
3. Signature of informed consent.
4. Inpatient and remain hospitalized for at least 10 days.

5. The following haematological diagnosis:

   1. acute lymphoblastic leukemia.
   2. acute myelogenous leukemia.
   3. relapsed non-Hodgkin lymphoma.
6. Receiving Chemotherapy scheme as a treatment for the underlying disease

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine 0.12% & Ethyl Alcohol 7%; Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.	Drug: chlorhexidine 0.12%/Ethyl alcohol 7%; Mouth rinses with chlorhexidine 0.12%-based solution
Active Comparator: Ethyl Alcohol 7%; Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.	Drug: Ethyl Alcohol 7%; Mouth rinses with Ethyl Alcohol 7%-based solution
Experimental: Chlorhexidine 2% & Ethyl Alcohol 7%; Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.	Drug: Chlorhexidine 2%/Ethyl alcohol 7%; Mouth rinses with chlorhexidine 2%-based solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of oral colonization by gram-negative bacteria	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Regional de Alta Especialidad del Bajio
• Collaborators: Universidad de Guanajuato
• Investigators: Principal Investigator: Lauro F Amador, Researcher, Hospital Regional Alta Especialidad Bajio

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Ci-HRAEB-2015-004