Nosocomial PneumoniaPhase 4NCT00610324
Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients
A Phase 4 study testing Chlorhexidine gluconate and Potassium permanganate in people with Nosocomial Pneumonia and Healthcare-Associated Pneumonia, run by King Edward Memorial Hospital at 1 site in India.
Trial summary
Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Nosocomial Pneumonia, Healthcare-Associated Pneumonia, Aspiration Pneumonia
- What is being tested?
- Chlorhexidine gluconate and Potassium permanganate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteIndia
- Study dates
- May 2004to Dec 2007
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the medical intensive care unit and are expected to stay in ICU for > 48 hours
Who cannot join
- Pregnant women
- Patients with nosocomial pneumonia at time of ICU admission
- Patients with community-acquired pneumonia at time of ICU admission
- Patients in whom oropharyngeal cleansing is contra-indicated
Trial locations and contacts
1 site in 1 country.
India1 site
Medical-Neuro Intensive Care Unit, K E M Hospital, Parel
Mumbai, Maharashtra, 400012
About this study
Official title: Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial
Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. The present study proposes to study the effectiveness of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial pneumonia in ICU patients admitted to a single intensive care unit of an Indian public hospital
Read the detailed description
Nosocomial pneumonia is common in intensive care units (ICU) patients and is associated with increase in mortality rates by 24% to 76% in various studies. Interventions that effectively prevent nosocomial pneumonia are strategically important in order to reduce morbidity, mortality and healthcare costs. Colonization of the pharynx has been implicated as the reservoirs for pathogens causing nosocomial pneumonia and interventions like selective digestive decontamination have been tried to control this source of infection. Recently, colonization of the dental plaque by aerobic organisms with subsequent aspiration into the lower respiratory tract has received attention. Previous smaller studies using antiseptic agents to sterilize dental plaques in patients at risk of pneumonia have shown conflicting results. The present study aims to determine whether twice daily oral cleansing with 0.2% chlorhexidine reduces the incidence of nosocomial pneumonia in patients staying in the ICU for >48 hours.
After obtaining informed consent, subjects would be randomized to treatment with either 0.2% chlorhexidine gluconate (CHG) solution or 0.01% potassium permanganate solution (PP) (Control Group), as per the protocol approved by the Institutional Ethics Committee. At baseline, the parameters which would be noted are: age, sex, surgical or non-surgical status, immunosuppression, chronic ailments, smoking and alcohol consumption, Glasgow coma scale score (GCS), laboratory parameters and blood gas analysis. All subjects would be followed up daily and the GCS, presence of nasogastric tube (feeds), endotracheal tube, tracheostomy, ventilator, central venous and urinary catheterization, anti-stress ulcer prophylaxis and prior antibiotic use will be noted. Presence or absence of nosocomial pneumonia would also be noted daily. Lower respiratory secretions would be obtained by the protected non-bronchoscopic mini-BAL technique in order to identify the causative organisms. All the subjects will be followed up daily until discharge from the ICU or death.
Primary outcome variable was the development of nosocomial pneumonia during the ICU stay. Secondary outcome variables were hospital mortality, length of ICU stay.
A total of 506 patients will have to be studied (approximately 253 patients in each treatment group). This study will have a statistical power of 75% to detect a 50% reduction in the incidence of nosocomial pneumonia in the intervention group with a 95% level of confidence assuming that incidence of pneumonia in the control group is 16%.
- Conditions
- Nosocomial Pneumonia, Healthcare-Associated Pneumonia, Aspiration Pneumonia, Ventilator-Associated Pneumonia
- Being tested
- Chlorhexidine gluconate, Potassium permanganate
- Keywords
- oropharyngeal cleansing, oral decontamination, oropharyngeal bacterial flora, oropharyngeal colonization, critical illness, mechanical ventilation, tracheal intubation, prophylaxis
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Aspiration, Pneumonia, Ventilator-Associated, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
Potassium permanganateDrug
Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate Receives: Drug: Chlorhexidine gluconate |
| 2 | Active comparator | Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate Receives: Drug: Potassium permanganate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of nosocomial pneumonia
Measured: During hospital stay
Secondary outcomes (2)
In-hospital mortality
Measured: During hospital stay
Length of ICU stay (days)
Measured: Till discharge from ICU or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMay 2004
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nosocomial 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dilip R Karnad, MD,FACP,FRCP, Principal investigator, Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610324
- Sponsor's protocol ID
- DRK-CHEX
- Status last verified
- Jan 2008
- First submitted
- 16 Jan 2008
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Abele-Horn M, Dauber A, Bauernfeind A, Russwurm W, Seyfarth-Metzger I, Gleich P, Ruckdeschel G. Decrease in nosocomial pneumonia in ventilated patients by selective oropharyngeal decontamination (SOD). Intensive Care Med. 1997 Feb;23(2):187-95. doi: 10.1007/s001340050314.
PubMed 9069004DeRiso AJ 2nd, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Chest. 1996 Jun;109(6):1556-61. doi: 10.1378/chest.109.6.1556.
PubMed 8769511Fourrier F, Cau-Pottier E, Boutigny H, Roussel-Delvallez M, Jourdain M, Chopin C. Effects of dental plaque antiseptic decontamination on bacterial colonization and nosocomial infections in critically ill patients. Intensive Care Med. 2000 Sep;26(9):1239-47. doi: 10.1007/s001340000585.
PubMed 11089748Francis JR, Hunter B, Addy M. A comparison of three delivery methods of chlorhexidine in handicapped children. I. Effects on plaque, gingivitis, and toothstaining. J Periodontol. 1987 Jul;58(7):451-5. doi: 10.1902/jop.1987.58.7.451.
PubMed 2957488
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00610324
- Acronym / sponsor ID
- DRK-CHEX
- Conditions
- Nosocomial Pneumonia, Healthcare-Associated Pneumonia, Aspiration Pneumonia, Ventilator-Associated Pneumonia
- Keywords
- oropharyngeal cleansing, oral decontamination, oropharyngeal bacterial flora, oropharyngeal colonization, critical illness, mechanical ventilation, tracheal intubation, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- King Edward Memorial HospitalUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Feb 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.
Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. The present study proposes to study the effectiveness of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial pneumonia in ICU patients admitted to a single intensive care unit of an Indian public hospital
Detailed description
Nosocomial pneumonia is common in intensive care units (ICU) patients and is associated with increase in mortality rates by 24% to 76% in various studies. Interventions that effectively prevent nosocomial pneumonia are strategically important in order to reduce morbidity, mortality and healthcare costs. Colonization of the pharynx has been implicated as the reservoirs for pathogens causing nosocomial pneumonia and interventions like selective digestive decontamination have been tried to control this source of infection. Recently, colonization of the dental plaque by aerobic organisms with subsequent aspiration into the lower respiratory tract has received attention. Previous smaller studies using antiseptic agents to sterilize dental plaques in patients at risk of pneumonia have shown conflicting results. The present study aims to determine whether twice daily oral cleansing with 0.2% chlorhexidine reduces the incidence of nosocomial pneumonia in patients staying in the ICU for >48 hours.
After obtaining informed consent, subjects would be randomized to treatment with either 0.2% chlorhexidine gluconate (CHG) solution or 0.01% potassium permanganate solution (PP) (Control Group), as per the protocol approved by the Institutional Ethics Committee. At baseline, the parameters which would be noted are: age, sex, surgical or non-surgical status, immunosuppression, chronic ailments, smoking and alcohol consumption, Glasgow coma scale score (GCS), laboratory parameters and blood gas analysis. All subjects would be followed up daily and the GCS, presence of nasogastric tube (feeds), endotracheal tube, tracheostomy, ventilator, central venous and urinary catheterization, anti-stress ulcer prophylaxis and prior antibiotic use will be noted. Presence or absence of nosocomial pneumonia would also be noted daily. Lower respiratory secretions would be obtained by the protected non-bronchoscopic mini-BAL technique in order to identify the causative organisms. All the subjects will be followed up daily until discharge from the ICU or death.
Primary outcome variable was the development of nosocomial pneumonia during the ICU stay. Secondary outcome variables were hospital mortality, length of ICU stay.
A total of 506 patients will have to be studied (approximately 253 patients in each treatment group). This study will have a statistical power of 75% to detect a 50% reduction in the incidence of nosocomial pneumonia in the intervention group with a 95% level of confidence assuming that incidence of pneumonia in the control group is 16%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Chlorhexidine gluconateTwice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate |
| 2 | Active comparator | Drug: Potassium permanganateTwice-daily oropharyngeal cleansing with 0.01% Potassium permanganate |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the medical intensive care unit and are expected to stay in ICU for > 48 hours
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with nosocomial pneumonia at time of ICU admission
- Patients with community-acquired pneumonia at time of ICU admission
- Patients in whom oropharyngeal cleansing is contra-indicated
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 gluconateTwice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate | Drug | 1 |
| Potassium permanganateTwice-daily oropharyngeal cleansing with 0.01% Potassium permanganate | Drug | 2 |
Primary outcome
Development of nosocomial pneumonia
Time frame: During hospital stay
2 secondary outcomes
In-hospital mortality
Time frame: During hospital stay
Length of ICU stay (days)
Time frame: Till discharge from ICU or death
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 7 Feb 2008.
- Background: PubMed 9069004Abele-Horn M, Dauber A, Bauernfeind A, Russwurm W, Seyfarth-Metzger I, Gleich P, Ruckdeschel G. Decrease in nosocomial pneumonia in ventilated patients by selective oropharyngeal decontamination (SOD). Intensive Care Med. 1997 Feb;23(2):187-95. doi: 10.1007/s001340050314.
- Background: PubMed 8769511DeRiso AJ 2nd, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Chest. 1996 Jun;109(6):1556-61. doi: 10.1378/chest.109.6.1556.
- Background: PubMed 11089748Fourrier F, Cau-Pottier E, Boutigny H, Roussel-Delvallez M, Jourdain M, Chopin C. Effects of dental plaque antiseptic decontamination on bacterial colonization and nosocomial infections in critically ill patients. Intensive Care Med. 2000 Sep;26(9):1239-47. doi: 10.1007/s001340000585.
- Background: PubMed 2957488Francis JR, Hunter B, Addy M. A comparison of three delivery methods of chlorhexidine in handicapped children. I. Effects on plaque, gingivitis, and toothstaining. J Periodontol. 1987 Jul;58(7):451-5. doi: 10.1902/jop.1987.58.7.451.
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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.
Dilip R Karnad, MD,FACP,FRCP principal investigator
Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
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 Chlorhexidine gluconate and Potassium permanganate in people with Nosocomial Pneumonia and Healthcare-Associated Pneumonia, run by King Edward Memorial Hospital 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 1 inclusion and 4 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 7 Feb 2008. 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. 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?
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?
Development of nosocomial pneumonia (time frame: During hospital stay). 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 NCT00610324, which also lists 4 linked publications.
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 7 Feb 2008.