Decolonisation Strategies in Intensive Care

RGNOSIS: Ecological Effects of Decolonisation Strategies in Intensive Care - RGNOSIS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002604-41-ES

Enrollment

10800

Registered

2014-03-18

Start date

2014-01-31

Completion date

Unknown

Last updated

2014-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonisation and Infection with (multi drug resistant) Gram negative bacteria in ICU patients

Interventions

Trade Name: MYcostatin Product Name: Nystatin suspension Pharmaceutical Form: Gastroenteral suspension Trade Name: Promixin Product Name: Colistin Sulphate Pharmaceutical Form: Gastroenteral suspensi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients admitted to the Intensive Care Unit and - mechanically ventilated (invasive or non invasive mechanical ventilation) with an expected duration of mechanical ventilation > 24 hours Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3000

Exclusion criteria

Exclusion criteria: - preganancy - <18 years old - known allergy to any of the medications or agents used

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteremia when compared to standard care;Secondary Objective: - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities of MDR-GNB during 3 decolonisation regimens. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 and in hospital mortality - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, during each phase of the study.;Primary end point(s): To determine the ecological effects on MDR-GNB of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patient;Timepoint(s) of evaluation of this end point: Endpoint will be determined at discharge of the patient from the ICU	—

Measure

Time frame

Main Objective: To determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteremia when compared to standard care;Secondary Objective: - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities of MDR-GNB during 3 decolonisation regimens. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 and in hospital mortality - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, during each phase of the study.;Primary end point(s): To determine the ecological effects on MDR-GNB of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patient;Timepoint(s) of evaluation of this end point: Endpoint will be determined at discharge of the patient from the ICU

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: all secondary endpoints will be determined on discharge of the participant from the ICU, except for 28th day mortality, which will be determined on day 28 after ICU admission.;Secondary end point(s): - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - 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. - 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. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities (reproductive number per hospital admission, RA) of MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 mortality and in hospital mortality when compared to standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing ICU-acquired bacteraemia when compared to standard care (SC). - 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 QIP	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: all secondary endpoints will be determined on discharge of the participant from the ICU, except for 28th day mortality, which will be determined on day 28 after ICU admission.;Secondary end point(s): - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - 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. - 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. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities (reproductive number per hospital admission, RA) of MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 mortality and in hospital mortality when compared to standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing ICU-acquired bacteraemia when compared to standard care (SC). - 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 QIP

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Countries

Spain

Contacts

Public ContactDra. Anna cruceta

CTU (servicio de Farmacología clinica).

acruceta@clinic.ub.es+ 9322754004380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026