Mechanical Ventilation for More Than 48 Hours.Phase 4NCT01883596
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.
A Phase 4 study testing 0.12% chlorhexidine solution in people with Mechanical Ventilation for More Than 48 Hours., run by Sinaloa Pediatric Hospital at 1 site in Mexico.
Trial summary
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Mechanical Ventilation for More Than 48 Hours.
- What is being tested?
- 0.12% chlorhexidine solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2012to Dec 2016
- Phase
- Phase 4
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 1 month to 18 years admitted to the intensive care unit.
- Intubated for more than 48 hours.
Who cannot join
- Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
- Allergy to chlorhexidine.
- Known immune deficiency.
- Elimination Criteria:
- Transfer to another hospital.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Sinaloa Pediatric Hospital
Culiacán, Sinaloa, 80200
Jesus J Martinez, MD, +52 (667) 7139004 ext. 274, jjmtz64@hotmail.com
Luz I Zamudio, MD, +52 (667) 7164686, zluz_isabel@hotmail.com
About this study
Official title: Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Read the detailed description
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
- Being tested
- 0.12% chlorhexidine solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% chlorhexidine solutionDrug
Also called Peridex, Betasept, PerioGard.
Bexident® (0.12% chlorhexidine solution)
PlaceboDrug
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
| Study group | Role | What they receive |
|---|---|---|
| 0.12% Chlorhexidine | Experimental | Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs. Receives: Drug: 0.12% chlorhexidine solution |
| Placebo | Placebo comparator | 7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator associated pneumonia
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Secondary outcomes (3)
Mortality
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Days of mechanical ventilation
Measured: From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
Length of stay
Measured: From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation for More Than 48 Hours.Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinaloa Pediatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Javier Martínez-García, Sinaloa Pediatric Hospital
- Investigators
- Jesus J Martinez, MD, Study chair, Sinaloa Pediatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883596
- Sponsor's protocol ID
- HPS-02
- Status last verified
- Dec 2015
- First submitted
- 11 Jun 2013
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01883596
- Acronym / sponsor ID
- HPS-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sinaloa Pediatric HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Jun 2013 (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.
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Detailed description
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.12% Chlorhexidine | Experimental | Drug: 0.12% chlorhexidine solutionBexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs. |
| Placebo | Placebo comparator | Drug: Placebo7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 1 month to 18 years admitted to the intensive care unit.
- Intubated for more than 48 hours.
Key exclusion criteria (5 listed)
- Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
- Allergy to chlorhexidine.
- Known immune deficiency.
- Transfer to another hospital.
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 |
|---|---|---|
| 0.12% chlorhexidine solutionAlso: Peridex, Betasept, PerioGard.Bexident® (0.12% chlorhexidine solution) | Drug | 0.12% Chlorhexidine |
| Placebo7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. | Drug | Placebo |
Primary outcome
Incidence of ventilator associated pneumonia
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
3 secondary outcomes
Mortality
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Days of mechanical ventilation
Time frame: From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
Length of stay
Time frame: From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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.
Jesus J Martinez, MD study chair
Sinaloa Pediatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.12% chlorhexidine solution in people with Mechanical Ventilation for More Than 48 Hours., run by Sinaloa Pediatric Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 8 Dec 2015. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesus J Martinez, MD (+52 (667) 7139004 ext. 274, jjmtz64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator associated pneumonia (time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.