Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350987
Status:
COMPLETED
Last Update Posted:
2008-09-23
First Post:
2006-07-11
Brief Title:
Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections The ProHOSP Study
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections The ProHOSP Study
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to test if procalcitonin PCT guided antibiotic stewardship in patients with lower respiratory tract infection LRTI will be non-inferior with at worst a 75 higher combined failure rate as compared to standard care practice current guidelines for LRTI with reduced total antibiotic AB use and hospitalization rate and duration respectively
Detailed Description:
Background Acute lower respiratory tract infections LRTI ie acute bronchitis and acute exacerbations of chronic obstructive pulmonary disease AECOPD and community-acquired pneumonia CAP employ important hospital resources and often unnecessary antibiotic AB treatment courses We demonstrated in four intervention trials enrolling 1200 patients that procalcitonin PCT-guidance markedly reduces AB prescription and duration To ascertain the external validity safety and potential to improve the allocation of health care resources a non-inferiority multicenter intervention trial has to be done
Aim To compare a strategy based on evidence-based guidelines with PCT guided AB therapy in LRTI with respect to outcome combined disease-specific failure rates use of AB and hospital resources
Design Investigator-initiated controlled trial with an open intervention Patients admitted with LRTI to hospital will be included and randomized 11 either to standard management or to the PCT-guided prescription of AB Randomization will be stratified by centre the hospital and type of LRTI Acute bronchitisAECOPDCAP
Setting Teaching hospitals and tertiary care clinics from northwestern and central Switzerland
Patients 18 years or older with LRTI of 1 and 28 days duration Excluded are patients without informed consent not fluent in German unlikely to comply severe immuno-suppression terminal condition where death is expected to occur during the current hospitalization immediate need for intensive care
Endpoints
Primary Risk of combined disease-specific failure after 30 days
Secondary AB exposure side effects from ABs time to AB treatment rate and duration of hospitalization time to clinical stability disease activity scores
Endpoints will be assessed at baseline daily in hospitalized patients and after 30 and 180 days by structured phone interviews by blinded medical students
Intervention Participating physicians will receive evidence-based guidelines for the management of patients with LRTIs Patients with LRTI will be randomized to PCT plus guidelines PCT group versus only guidelines-guided AB treatment control group In patients randomized to the PCT group the use of ABs will be more or less discouraged 01 or 025 ugL or encouraged 05 or 025 ugL respectively A re-evaluation after 6 to 24 hours in patients in whom antibiotics are withheld with worsening or non-improvement of vital signs with PCT 01 or 025 ugL is recommended During hospitalization patients with AB treatment will be reassessed at day 3 5 and 7 and in patients randomized to the PCT group it is recommended to stop AB based on PCT levels In AB-treated outpatients or discharged patients with AECOPD and CAP randomized to the PCT group with uncomplicated course the recommended duration of AB therapy will be based on the last PCT level and will be as follows 05 ugL 5 days 025 ugL 3 days 025 ugL stop AB
Variables and measurement Centers have to consecutively enroll all patients with LRTI Baseline data on medical history and clinical items additional diagnostic tests co-morbidity final prescribed treatment and reasons for hospital admission and stay will be collected After a pilotfeasibility phase of 3 months study recruitment will continue from Mar 2007 to Apr 2008
Study hypothesis PCT guidance will be non-inferior with at worst a 75 higher combined failure rate as compared to standard care practice with a reduced total AB use and hospitalization rate and duration respectively
Analyses These will be done based on an intention-to-treat and a per-protocol principle With an assumed combined failure rate of 15 to 20 a non-inferiority margin of 75 a maximum of 5 losses to follow-up a value of 5 and power of 90 the total sample size is 806 α one-sided to 1002
Interim monitoring Regular review of serious adverse events quality and integrity of the study by an independent data safety and monitoring board Safety interim analysis and blinded assessment ie with both arms pooled of the diagnostic and prognostic accuracy of biomarkers after 50 of the patients recruited
Ancillary projects Six related projects will be performed alongside to this study including cost-effectiveness nursing and social influence on hospitalization prognostic value of novel biomarkers to synergize scientific efforts
Significance Due to the high prevalence and absorption of hospital resources this study will offer the potential for large improvements in the management of LRTIs along with substantial reduction in hospitalization costs and AB resistance
Aim To compare a strategy based on evidence-based guidelines with PCT guided AB therapy in LRTI with respect to outcome combined disease-specific failure rates use of AB and hospital resources
Design Investigator-initiated controlled trial with an open intervention Patients admitted with LRTI to hospital will be included and randomized 11 either to standard management or to the PCT-guided prescription of AB Randomization will be stratified by centre the hospital and type of LRTI Acute bronchitisAECOPDCAP
Setting Teaching hospitals and tertiary care clinics from northwestern and central Switzerland
Patients 18 years or older with LRTI of 1 and 28 days duration Excluded are patients without informed consent not fluent in German unlikely to comply severe immuno-suppression terminal condition where death is expected to occur during the current hospitalization immediate need for intensive care
Endpoints
Primary Risk of combined disease-specific failure after 30 days
Secondary AB exposure side effects from ABs time to AB treatment rate and duration of hospitalization time to clinical stability disease activity scores
Endpoints will be assessed at baseline daily in hospitalized patients and after 30 and 180 days by structured phone interviews by blinded medical students
Intervention Participating physicians will receive evidence-based guidelines for the management of patients with LRTIs Patients with LRTI will be randomized to PCT plus guidelines PCT group versus only guidelines-guided AB treatment control group In patients randomized to the PCT group the use of ABs will be more or less discouraged 01 or 025 ugL or encouraged 05 or 025 ugL respectively A re-evaluation after 6 to 24 hours in patients in whom antibiotics are withheld with worsening or non-improvement of vital signs with PCT 01 or 025 ugL is recommended During hospitalization patients with AB treatment will be reassessed at day 3 5 and 7 and in patients randomized to the PCT group it is recommended to stop AB based on PCT levels In AB-treated outpatients or discharged patients with AECOPD and CAP randomized to the PCT group with uncomplicated course the recommended duration of AB therapy will be based on the last PCT level and will be as follows 05 ugL 5 days 025 ugL 3 days 025 ugL stop AB
Variables and measurement Centers have to consecutively enroll all patients with LRTI Baseline data on medical history and clinical items additional diagnostic tests co-morbidity final prescribed treatment and reasons for hospital admission and stay will be collected After a pilotfeasibility phase of 3 months study recruitment will continue from Mar 2007 to Apr 2008
Study hypothesis PCT guidance will be non-inferior with at worst a 75 higher combined failure rate as compared to standard care practice with a reduced total AB use and hospitalization rate and duration respectively
Analyses These will be done based on an intention-to-treat and a per-protocol principle With an assumed combined failure rate of 15 to 20 a non-inferiority margin of 75 a maximum of 5 losses to follow-up a value of 5 and power of 90 the total sample size is 806 α one-sided to 1002
Interim monitoring Regular review of serious adverse events quality and integrity of the study by an independent data safety and monitoring board Safety interim analysis and blinded assessment ie with both arms pooled of the diagnostic and prognostic accuracy of biomarkers after 50 of the patients recruited
Ancillary projects Six related projects will be performed alongside to this study including cost-effectiveness nursing and social influence on hospitalization prognostic value of novel biomarkers to synergize scientific efforts
Significance Due to the high prevalence and absorption of hospital resources this study will offer the potential for large improvements in the management of LRTIs along with substantial reduction in hospitalization costs and AB resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None