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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02414581 |
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Date of registration:
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03/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%
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Scientific title:
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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 |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02414581 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Lauro F Amador, Researcher |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Regional Alta Especialidad Bajio |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neutropenia
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Intervention(s)
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Drug: chlorhexidine 0.12%/Ethyl alcohol 7%
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Drug: Chlorhexidine 2%/Ethyl alcohol 7%
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Drug: Ethyl Alcohol 7%
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Primary Outcome(s)
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Rate of oral colonization by gram-negative bacteria
[Time Frame: 10 days]
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Secondary Outcome(s)
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Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
[Time Frame: Baseline]
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Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
[Time Frame: 10 days]
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Number of participants with presence of severe neutropenia and fever in each study group.
[Time Frame: 10 days]
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Secondary ID(s)
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Ci-HRAEB-2015-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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