Infections and Respiratory InfectiousPhase 3CHLORHEXNCT01613365
Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections
A Phase 3 study testing Chlorhexidine Gluconate in people with Infections and Respiratory Infectious, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections and Respiratory Infectious
- What is being tested?
- Chlorhexidine Gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to May 2015
- 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
- Adult men and women over 18 years
- Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis
- Anatomical resections (segmentectomy, lobectomy, pneumonectomy)
- With mediastinal lymph node dissection.
- Patient fit for operation
- After informed consent
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- Non inclusion criteria:
- Patients < 18 years
- Pulmonary infectious lesions
- Recent respiratory infections
- Tracheostomy
- Swallow difficulties
- Need for non-invasive ventilation before surgery
- Documented sensibility to Chlorhexidine
- Previous ENT cancer
- Previous thoracic surgery
- Patients with an oral assessment score (OAG) >9
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.
Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.
- Conditions
- Infections and Respiratory Infectious
- Being tested
- Chlorhexidine Gluconate, Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate
PlaceboDrug
Oropharyngeal and nasopharyngeal decontamination with placebo
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate | Experimental | Not described Receives: Drug: Chlorhexidine Gluconate |
| placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients requiring ventilatory support
Measured: 36 MONTHS
Secondary outcomes (2)
occurrence of documented hospital-acquired respiratory infections
Measured: 36 MONTHS
occurrence of documented non-respiratory hospital-acquired infections
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Infections and Respiratory InfectiousStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de MarseilleD'JOURNO BENOIT, Principal investigator, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613365
- Sponsor's protocol ID
- 2011-004536-63
- Other IDs
- 2011-24
- Acronym
- CHLORHEX
- Status last verified
- Aug 2015
- First submitted
- 5 Jun 2012
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Journo XB, Falcoz PE, Alifano M, Le Rochais JP, D'Annoville T, Massard G, Regnard JF, Icard P, Marty-Ane C, Trousse D, Doddoli C, Orsini B, Edouard S, Million M, Lesavre N, Loundou A, Baumstarck K, Peyron F, Honore S, Dizier S, Charvet A, Leone M, Raoult D, Papazian L, Thomas PA. Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial. Intensive Care Med. 2018 May;44(5):578-587. doi: 10.1007/s00134-018-5156-2. Epub 2018 Apr 18.
PubMed 29671041
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01613365
- Acronym / sponsor ID
- CHLORHEX / 2011-004536-63
- Conditions
- Infections and Respiratory Infectious
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jun 2012 (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.
Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.
Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate | Experimental | Drug: Chlorhexidine Gluconate |
| placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult men and women over 18 years
- Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis
- Anatomical resections (segmentectomy, lobectomy, pneumonectomy)
- With mediastinal lymph node dissection.
- Patient fit for operation
Key exclusion criteria (0 listed)
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 GluconateOropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate | Drug | chlorhexidine gluconate |
| PlaceboOropharyngeal and nasopharyngeal decontamination with placebo | Drug | placebo |
Primary outcome
proportion of patients requiring ventilatory support
Time frame: 36 MONTHS
2 secondary outcomes
occurrence of documented hospital-acquired respiratory infections
Time frame: 36 MONTHS
occurrence of documented non-respiratory hospital-acquired infections
Time frame: 36 months
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 Aug 2015.
- Derived from this study: PubMed 29671041D'Journo XB, Falcoz PE, Alifano M, Le Rochais JP, D'Annoville T, Massard G, Regnard JF, Icard P, Marty-Ane C, Trousse D, Doddoli C, Orsini B, Edouard S, Million M, Lesavre N, Loundou A, Baumstarck K, Peyron F, Honore S, Dizier S, Charvet A, Leone M, Raoult D, Papazian L, Thomas PA. Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial. Intensive Care Med. 2018 May;44(5):578-587. doi: 10.1007/s00134-018-5156-2. Epub 2018 Apr 18.
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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.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
D'JOURNO BENOIT principal investigator
AP HM
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 Gluconate in people with Infections and Respiratory Infectious, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 17 inclusion and 0 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 Aug 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 France. 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?
proportion of patients requiring ventilatory support (time frame: 36 MONTHS). 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 NCT01613365, 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 7 Aug 2015.