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

Neutropenia Clinical Trial

Official title:

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414581
• Other study ID #: Ci-HRAEB-2015-004
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• chlorhexidine 0.12%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 0.12%-based solution
• Ethyl Alcohol 7%
Mouth rinses with Ethyl Alcohol 7%-based solution
• Chlorhexidine 2%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 2%-based solution

Locations

Country	Name	City	State
Mexico	Hospital Regional Alta Especialidad Bajio	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio	Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of oral colonization by gram-negative bacteria		10 days
Secondary	Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.		Baseline
Secondary	Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm		10 days
Secondary	Number of participants with presence of severe neutropenia and fever in each study group.		10 days