NeutropeniaPhase 3NCT02414581
Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%
A Phase 3 study testing chlorhexidine 0.12%/Ethyl alcohol 7%, Ethyl Alcohol 7% and Chlorhexidine 2%/Ethyl alcohol 7% in people with Neutropenia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- chlorhexidine 0.12%/Ethyl alcohol 7%, Ethyl Alcohol 7% and Chlorhexidine 2%/Ethyl alcohol 7%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2015to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- acute myelogenous leukemia.
- relapsed non-Hodgkin lymphoma.
- Receiving Chemotherapy scheme as a treatment for the underlying disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 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
Read the detailed description
Clinical triple-blind randomized controlled trial.
With two arms to the study:
- Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
- 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:
- The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
- The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
- Identify microbiologically gram-negative bacteria colonizing the oral cavity.
SECONDARY OBJECTIVES
- The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment
- Conditions
- Neutropenia
- Being tested
- chlorhexidine 0.12%/Ethyl alcohol 7%, Ethyl Alcohol 7%, Chlorhexidine 2%/Ethyl alcohol 7%
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine 0.12%/Ethyl alcohol 7%Drug
Mouth rinses with chlorhexidine 0.12%-based solution
Ethyl Alcohol 7%Drug
Mouth rinses with Ethyl Alcohol 7%-based solution
Chlorhexidine 2%/Ethyl alcohol 7%Drug
Mouth rinses with chlorhexidine 2%-based solution
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine 0.12% & Ethyl Alcohol 7% | Experimental | Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days. Receives: 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. Receives: 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. Receives: Drug: Chlorhexidine 2%/Ethyl alcohol 7% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of oral colonization by gram-negative bacteria
Measured: 10 days
Secondary outcomes (3)
Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
Measured: Baseline
Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
Measured: 10 days
Number of participants with presence of severe neutropenia and fever in each study group.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Guanajuato
- Responsible party
- Principal investigator, Lauro Fabian Amador Medina, Hospital Regional de Alta Especialidad del Bajio
- Investigators
- Lauro F Amador, Researcher, Principal investigator, Hospital Regional Alta Especialidad Bajio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414581
- Sponsor's protocol ID
- Ci-HRAEB-2015-004
- Status last verified
- Sep 2016
- First submitted
- 3 Apr 2015
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12660125
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02414581
- Acronym / sponsor ID
- Ci-HRAEB-2015-004
- Conditions
- Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Collaborators
- Universidad de Guanajuato
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
- 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:
- The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
- The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
- Identify microbiologically gram-negative bacteria colonizing the oral cavity.
SECONDARY OBJECTIVES
- The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine 0.12% & Ethyl Alcohol 7% | Experimental | Drug: chlorhexidine 0.12%/Ethyl alcohol 7%Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days. |
| Ethyl Alcohol 7% | Active comparator | Drug: Ethyl Alcohol 7%Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days. |
| Chlorhexidine 2% & Ethyl Alcohol 7% | Experimental | Drug: Chlorhexidine 2%/Ethyl alcohol 7%Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorhexidine 0.12%/Ethyl alcohol 7%Mouth rinses with chlorhexidine 0.12%-based solution | Drug | Chlorhexidine 0.12% & Ethyl Alcohol 7% |
| Ethyl Alcohol 7%Mouth rinses with Ethyl Alcohol 7%-based solution | Drug | Ethyl Alcohol 7% |
| Chlorhexidine 2%/Ethyl alcohol 7%Mouth rinses with chlorhexidine 2%-based solution | Drug | Chlorhexidine 2% & Ethyl Alcohol 7% |
Primary outcome
Rate of oral colonization by gram-negative bacteria
Time frame: 10 days
3 secondary outcomes
Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
Time frame: Baseline
Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
Time frame: 10 days
Number of participants with presence of severe neutropenia and fever in each study group.
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Results publication: PubMed 12660125Pitten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauro F Amador, Researcher principal investigator
Hospital Regional Alta Especialidad Bajio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chlorhexidine 0.12%/Ethyl alcohol 7%, Ethyl Alcohol 7% and Chlorhexidine 2%/Ethyl alcohol 7% in people with Neutropenia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of oral colonization by gram-negative bacteria (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.