Clinical trial NCT02414581: Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neutropenia
Lead sponsor: Hospital Regional de Alta Especialidad del Bajio
Sponsor class: OTHER
Collaborators: name: Universidad de Guanajuato
First posted: 2015-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of oral colonization by gram-negative bacteria
timeFrame: 10 days
Secondary outcomes:
measure: Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
timeFrame: Baseline
measure: Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
timeFrame: 10 days
measure: Number of participants with presence of severe neutropenia and fever in each study group.
timeFrame: 10 days
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Hospital Regional Alta Especialidad Bajio
state: Guanajuato
Study officials:
affiliation: Hospital Regional Alta Especialidad Bajio
name: Lauro F Amador, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.