Ventilator Associated PneumoniaPhase 3NCT00597688
Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia
A Phase 3 study testing Chlorhexidine gel in people with Ventilator Associated Pneumonia, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children. Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Chlorhexidine gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2007to Apr 2009
- 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in PICU requiring mechanical ventilation
- Above the age of 3 months
- Oro or nasotracheal intubation
Who cannot join
- Known hypersensitivity to chlorhexidine
- Inability to access the oral cavity for any reason
- Patients with tracheostomy
- Mechanical ventilation for more than 24 hours prior to PICU admission.
- Death or extubation within 24 hours of ICU admission.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial
The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.
Read the detailed description
Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Chlorhexidine gel, Placebo gel
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gelDrug
Oral mucosal application of chlorhexidine gel
Placebo gelDrug
Oral mucosal application of placebo gel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Chlorhexidine gel Receives: Drug: Chlorhexidine gel |
| 2 | Placebo comparator | Placebo gel Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria
Measured: 21 days
Secondary outcomes (4)
Antibiotic sensitivity of organism cultured
Measured: 21 days
Duration of hospital stay
Measured: 21 days
Duration of ICU stay
Measured: 21 days
In hospital mortality rate
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
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 Ventilator Associated PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- RAKESH LODHA, Study director, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597688
- Sponsor's protocol ID
- Meghna
- Status last verified
- Feb 2009
- First submitted
- 10 Jan 2008
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sebastian MR, Lodha R, Kapil A, Kabra SK. Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial. Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.
PubMed 22760426
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00597688
- Acronym / sponsor ID
- Meghna
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Jan 2008 (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.
The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.
Detailed description
Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Chlorhexidine gelChlorhexidine gel |
| 2 | Placebo comparator | Drug: Placebo gelPlacebo gel |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients in PICU requiring mechanical ventilation
- Above the age of 3 months
- Oro or nasotracheal intubation
Key exclusion criteria (5 listed)
- Known hypersensitivity to chlorhexidine
- Inability to access the oral cavity for any reason
- Patients with tracheostomy
- Mechanical ventilation for more than 24 hours prior to PICU admission.
- Death or extubation within 24 hours of ICU admission.
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 gelOral mucosal application of chlorhexidine gel | Drug | 1 |
| Placebo gelOral mucosal application of placebo gel | Drug | 2 |
Primary outcome
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria
Time frame: 21 days
4 secondary outcomes
Antibiotic sensitivity of organism cultured
Time frame: 21 days
Duration of hospital stay
Time frame: 21 days
Duration of ICU stay
Time frame: 21 days
In hospital mortality rate
Time frame: 21 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 23 Mar 2011.
- Derived from this study: PubMed 22760426Sebastian MR, Lodha R, Kapil A, Kabra SK. Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial. Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.
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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.
RAKESH LODHA study director
All India Institute of Medical Sciences
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 gel in people with Ventilator Associated Pneumonia, run by All India Institute of Medical Sciences at 1 site in India.
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 3 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 23 Mar 2011. 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 India. 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 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?
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria (time frame: 21 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 NCT00597688, 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 23 Mar 2011.