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Ecological Effects of Decolonisation Strategies in Intensive Care (RGNOSIS)

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ClinicalTrials.gov Identifier: NCT02208154
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Paris 12 Val de Marne University
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht

Brief Summary:

Previous research has shown that applying certain treatments can reduce both the number of infections and the presence of resistant bacteria in the intensive care (ICU) and its patients. These treatments have been used as standard care throughout the world for many years, but they have not been compared to each other yet. The investigators aim to evaluate the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial infections in the ICU and to establish which treatment is the best.

All adult patients undergoing mechanical ventilation are eligible for this study and will receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will be obtained to measure the effects.

All ICU-patients will receive standard treatment, consisting of daily body washing with an antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers as endorsed by the WHO. According to 4 different study periods, each participant will receive one of the following extra treatments depending on his or her admission date:

  • Standard treatment only (this is the control group)
  • Chlorhexidine 1% oral gel, this is an antiseptic.
  • Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal decontamination, SOD).
  • Antibiotic mouth paste and suspension for the stomach and intestines containing 3 different antibiotics (selective digestive decontamination, SDD).

All treatments will be given 4 times daily with the purpose of killing harmful bacteria in the mouth (CHX, SOD,SDD) and digestive tract (SDD).

During the study the investigators will examine the effect of these treatments on:

  • the occurrence of blood stream infections with certain bacteria
  • cross-transmission of certain bacteria between patients
  • presence of these bacteria in the respiratory tract of the patients
  • patient survival

Benefits: Previous research has shown that these interventions can reduce infections in intensive care patients.

Risks: The interventions performed (both cultures and treatment) are considered safe and are already given as standard care in many ICUs throughout the world. There is a slight risk that bacteria become resistant to antibiotics: this will be monitored closely during the trial.


Condition or disease Intervention/treatment Phase
ICU-ecology (Multidrug Resistant Bacteria) ICU-acquired Bacteraemia Drug: Chlorhexidine oral care (CHX-Oro) Drug: Selective oropharyngeal decontamination (SOD) Drug: Selective Digestive Decontamination (SDD) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8665 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study is a cluster-randomized multicenter study with crossover of interventions within study centers. The first study period is always the baseline period. After six months, the first intervention period (order is determined by randomization) is implemented, followed by the second and third intervention. The intervention periods are separated by a wash out period of one month.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RGNOSIS: Ecological Effects of Decolonisation Strategies in Intensive Care
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care

Standard infection prevention measurements will be implemented before the baseline period and carried out throughout the entire trial. They consist of:

  • Chlorhexidine 2% body washings (CHX-BW) for all ICU patients. The face and neck of the patient will not be cleansed with Chlorhexidine to prevent irritation of the eyes and face.
  • A hand hygiene improvement program (HHIP) based on the program designed by the World Health organisation (WHO).
  • Standard oropharyngeal care consists of oral washing with sterile water (3-4 times daily) and tooth brush twice daily.
Drug: Chlorhexidine oral care (CHX-Oro)
Oromucosal gel consisting of chlorhexidine 1%, administered 4 times daily.
Other Names:
  • Chlorhexidine digluconate
  • CHX-Oro
  • Chlorhexidine 1% oromucosal gel
  • Corsodyl dental gel

Drug: Selective oropharyngeal decontamination (SOD)
SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10^5 units. SOD will be applied to the mouth 4 times daily until extubation.
Other Name: SOD

Drug: Selective Digestive Decontamination (SDD)

SDD consists of both:

  • SOD (described elsewhere)
  • AND 10 ml of an enteric suspension containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10^6 i.u, to be administered via the nasogastric tube.

The combination is administered 4 times daily (Unlike in previous studies, systemic antibiotics are not a part of SDD)

Other Name: SDD

Experimental: Chlorhexidine oral care (CHX-Oro)
Chlorhexidine digluconate oromucosal gel 1%, 2cm, to be administered 4 times daily, during invasive mechanical ventilation.
Drug: Chlorhexidine oral care (CHX-Oro)
Oromucosal gel consisting of chlorhexidine 1%, administered 4 times daily.
Other Names:
  • Chlorhexidine digluconate
  • CHX-Oro
  • Chlorhexidine 1% oromucosal gel
  • Corsodyl dental gel

Experimental: Selective oropharyngeal decontamination
Selective oropharyngeal decontamination (SOD) mouth paste containing colistin and tobramycin in a 2% concentration and nystatin 1 x 10^5 units, dosage 0.5g , to be administered 4 times daily during the entire period of invasive mechanical ventilation.
Drug: Selective oropharyngeal decontamination (SOD)
SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10^5 units. SOD will be applied to the mouth 4 times daily until extubation.
Other Name: SOD

Experimental: Selective digestive decontamination
Selective digestive decontamination (SDD), suspension via the nasogastric tube containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10^6 i.u., dosage 10ml, to be administered together with SOD (see above) 4 times daily during entire period of mechanical ventilation.
Drug: Selective Digestive Decontamination (SDD)

SDD consists of both:

  • SOD (described elsewhere)
  • AND 10 ml of an enteric suspension containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10^6 i.u, to be administered via the nasogastric tube.

The combination is administered 4 times daily (Unlike in previous studies, systemic antibiotics are not a part of SDD)

Other Name: SDD




Primary Outcome Measures :
  1. ICU-Ecology [ Time Frame: 27 months ]
    To determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteraemia when compared to standard care.


Secondary Outcome Measures :
  1. Cross-transmission rates [ Time Frame: 27 months ]
    To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care.

  2. Respiratory tract colonization [ Time Frame: 27 months ]
    To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB when compared to standard care.

  3. ward-level systemic antibiotic use [ Time Frame: 27 months ]
    To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use when compared to standard care.

  4. colonization in relation to bacteraemia [ Time Frame: 27 months ]
    To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia.

  5. transmission capacities of different bacteria [ Time Frame: 27 months ]
    To quantify species-specific nosocomial transmission capacities (reproductive number per hospital admission, RA) of MDR-GNB during 3 decolonisation regimens and during standard care.

  6. Patient survival [ Time Frame: 27 months ]
    To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 and in hospital mortality when compared to standard care.

  7. bacteraemia with resistant bacteria [ Time Frame: 27 months ]
    To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, including MRSA, VRE, MDR-GNB, Acinetobacter, S. maltophilia, and ceftazidime- and/or carbapenem resistant P. aeruginosa, during each phase of the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanical ventilation (only invasive ventilation: i.e. intubated patients or patients with tracheostomal ventilation)
  • no planned extubation within 24 hours When mechanical ventilation is not started directly after admission but later in the course of their ICU stay, patients are still eligible to participate.

Exclusion Criteria:

  • patients under the age of 18
  • patients with known allergy to any of the medications or agents used (i.e. colistin, tobramycin, nystatin or chlorhexidine )
  • pregnancy

Participation ends as soon as the patient is extubated or after tracheostomal ventilation has stopped (weaning completed).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208154


Locations
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Algemeen Ziekenhuis Sint Lucas
Gent, Belgium, 9000
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
CHU Liege
Liege, Belgium, 4000
Clinique Saint-Pierre Ottignies
Ottignies, Belgium, 340
Italy
Ospedale San Camillo
Rome, Italy, 00152
Portugal
Hospital Geral de Santo António (Centro Hospitalar do Porto, EPE)
Porto, Portugal, 4099-001
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, Portugal, 5000 - 508
Slovenia
University clinic of respiratory and allergic diseases
Golnik, Slovenia, 4204
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Universitario y Politécnico La Fé de Valencia
Valencia, Spain, 46026
United Kingdom
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Sponsors and Collaborators
MJM Bonten
Paris 12 Val de Marne University
Investigators
Principal Investigator: Marc JM Bonten, Prof. UMC Utrecht
Principal Investigator: Christian Brun-Buisson, Prof. UPEC Paris

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MJM Bonten, Professor of Molecular Epidemiology of Infectious Diseases, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02208154     History of Changes
Other Study ID Numbers: EudraCT 2012-002604-41
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by MJM Bonten, UMC Utrecht:
ICU acquired bacteraemia
colonization
decolonization
selective decontamination
multidrug resistant bacteria

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Tobramycin
Colistin
Nystatin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action