An observational study in Clostridium Difficile Infection, VRE Infection and Nosocomial Infection, sponsored by University Hospital of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by University Hospital of Cologne · Observational
Among 15 studies in Clostridium Infections with a site in Germany — 2 open to participants now, 2 under way, 1 of them phase 3. Clostridium Infections · Germany.
Among the 15 studies in Clostridium Infections with a site in Germany, this one is one of 2 that started in 2016, is one of 4 observational ones, and was the 12th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →2 of the 15 studies in Clostridium Infections with a site in Germany are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Germany, United States, Australia and 11 more countries
Ages 18+
Vedanta Biosciences, Inc. · Sites in Germany, United States, Australia and 21 more countries
Ages 12+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2016.
This study's enrollment of 80,000 is above the median of 226 across 52 observational studies indexed under Clostridium Infections.
Median enrollment 230 across the 11 interventional studies, 1,004 across the 4 observational. Of the 10 that completed or were terminated, 6 (60%) have results posted.
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10 of 15 have an industry lead sponsor. The 10 most frequent:
University Hospital of Cologne is the lead sponsor of 42 studies on the registry; 15 are open to participants now.
University Hospital of Cologne has 1 study filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
2 of the studies in Clostridium Infections with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
Among the 15 studies in Clostridium Infections with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Throughout project, the investigators design, evaluate and disseminate infection control and antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium difficile infection (CDI). The measures will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates, which were identified throughout previous studies. The infection control package will include staff training, hand hygiene programs and disinfection measures. Throughout the ABS package, investigators will develop and implement ABS measures specifically designed for patients at the highest risk of developing hospital-acquired infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS actions even in critically ill patients are early reduction of exposure based on microbiological results, timely cessation of anti-infective treatment, thoughtful implementation of screening measures and biomarkers, defined approaches to patients known to be allergic to penicillins, and vigorous enforcement of clinical and microbiological diagnosis of infection focus.
The IC and ABS measures aim at educating and assisting clinical personnel in realizing treatments according to official guidelines. There will not be a direct contact between study personnel and patient. There will be no direct recruitment of patients.
In recent years, a distinct group of healthcare-associated pathogens (HPs) has become highly prevalent among hospital inpatients worldwide. Clostridium difficile, vancomycin-resistant enterococci (VRE), and multi-resistant gram-negative bacteria (MRGN) today are an immediate threat to hospitalized patients in Western countries, given inferior outcomes and prolonged treatment associated with such infections.
There are two key clinical strategies to prevent transmission and reduce the overall incidence of infections by Clostridium difficile and other gut-derived HPs. Infection control (IC) measures act by avoiding in-hospital transmissions using various interventions, including hand hygiene, contact isolation and environmental cleaning/disinfection. Antibiotic stewardship (ABS) on the other hand aims at reducing selective pressure by ascertaining adequacy of treatment duration, dose, and selection of antibiotics.However, there is a scarcity of studies showing effectiveness of these strategies in actually reducing nosocomial infection by HPs. Single room contact isolation has deleterious implications, i.e. increased cost, decreased patient contacts and quality of life, but has not been proven effective for most HPs. Current ABS concepts are usually not aimed at the patients with the highest antibiotic consumption and the highest risk of contracting nosocomial infection by HPs, e.g. patients with neutropenia following chemotherapy.
ABSOLUTE is a comprehensive clinical study programme assessing IC/ABS measures to reduce Clostridium difficile infections (CDI) on high-incidence HP/CDI wards in a stepped-wedge cluster-randomized trial. The study will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates, which will be identified throughout previous study by the German Center for Infection Research (DZIF). This design was chosen as high-risk groups allow optimal resource utilization by expedited observation of target outcomes and because there is a translational gap towards implementing established strategies of infection control and ABS in critically ill patient groups.
Each partner site will identify eight observation wards. To allow measurement of secondary endpoints relevant to the IC/ABS bundle, especially safety, at least three of the sites should include their hematology/oncology department into the analysis. The other wards/departments will be selected based on CDI epidemiology. Incidence of CDI on candidate study wards/departments should exceed the 75 percentile based on R-Net (DZIF study) data collected during the preparation phase. The study coordinators will make the ultimate decision on the participating wards based on discussion with the local team of investigators. Besides the above-mentioned entry criteria, knowledge of current practices and approachability of the ward and the related staff may be regarded during the discussion. In total, each site will perform the analysis on at least ten wards of at least three departments.
Infection control measures for Clostridium difficile are well established and can be easily applied into hospital routine. This work package can therefore start ahead of the ABS bundle with measures aimed at reducing transmission of Clostridium difficile. The infection control bundle will include staff training, hand hygiene programs, disinfection measures, and contact isolation. Physicians will be discouraged to prescribe proton pump inhibitors (PPIs) where not explicitly needed. The bundle will be defined based on current literature. During the preparation phase of the study, investigators and other personnel from each site will receive central training courses in infection control measures targeted at reduction of effective Clostridium difficile transmission. It will be their task to train local staff (ward physicians, nurses) for compliance with the infection control bundle. For implementation, the investigator will adapt the bundle to specific local needs, discuss with the responsible department heads and ward staff, perform training and disseminate standards of care. The following indicators of process quality will be measured be the investigator in collaboration with the local hygiene staff: compliance observations (contact isolation, hand hygiene), education assessment (surveys), and PPI consumption.
Throughout the ABS work package, the investigators will develop and implement an ABS bundle specifically designed for patients at the highest risk of developing hospital-acquired infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS measures even in critically ill patients are early reduction of exposure based on microbiological results, timely cessation of anti-infective treatment, thoughtful implementation of screening measures and biomarkers, defined approaches to patients known to be allergic to penicillins, and vigorous enforcement of clinical and microbiological diagnosis of infection focus. The study hypothesis is, that the consumption of glycopeptides, carbapenems, daptomycin, tigecycline, and linezolid can be significantly reduced without jeopardizing patient outcomes. Reduction of these antibiotics will save last resort antimicrobials for documented breakthrough infections, reduce colonization and blood stream infections (BSI) with VRE and extended-spectrum beta-lactamase-producing gram-negatives (ESBL), and reduce the incidence of CDI.
As a first step, the investigators will guide a consensus process to develop specific ABS guidelines for hematology/oncology wards. They will develop this guideline primarily as German S2k (consensus) guideline, but will also seek publication in an international peer-reviewed journal. For the consensus process, relevant German medical societies and groups will be invited to send delegates. External experts will be invited to participate in the process and comment on the guideline as needed. The consensus process will consist of a kick-off face-to-face meeting with discussion and distribution of work packages, monthly telephone conferences and finally, a consensus meeting. The guidelines will contain advice on specific strategies to avoid excessive or wrong usage of anti-infectives and also on quality indicators of appropriate antibiotic use.
All study sites will receive comprehensive training in the defined ABS criteria as part of a 3-day course program. In addition, sites without established ABS groups or trained ABS experts will receive standard three-week training by the ABS Initiative (www.antibiotic-stewardship.de). Afterwards, implementation of the ABS measures will start. Antibiotic stewards will develop local standards of procedure based on the provided training and guidelines. They will then train the responsible staff and disseminate guidelines as best suited for the local work environment, e.g. as pocket cards, posters, or electronically. Point-prevalence investigations will assure adherence to guidelines.
Patients admitted on wards with high incidence of CDI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The infection control bundle will include staff training, hand hygiene programs, disinfection measures, and contact isolation. Physicians will be discouraged to prescribe proton pump inhibitors (PPIs) where not explicitly needed. The intervention bundle will be defined based on current literature. For implementation, the investigator will adapt the bundle to specific local needs, discuss with the responsible department heads and ward staff, perform training and disseminate standards of care.
Antibiotic stewards will develop local standards of procedure based on the provided training and guidelines. They will then train the responsible staff and disseminate guidelines as best suited for the local work environment, e.g. as pocket cards, posters, or electronically. Point-prevalence investigations and "antibiotic visits" will assure adherence to guidelines.
CDI incidence
Significant reduction of the overall CDI incidence on intervention wards following implementation of the combined IC and ABS bundles in pre-post analysis stratified by center.
Time frame: Baseline and every 3 months up to 144 weeks
Effectiveness of IC bundle through incidence of CDI or BSI by VRE and MRGN
Effectiveness of the infection control bundle for preventing nosocomial infection by incidence of a) CDI, or BSI by b) VRE, and c) MRGN by pre-post analysis before implementation of the ABS bundle.
Time frame: Baseline and every 3 months up to 144 weeks
PPI usage
Reduction in the consumption of PPIs, measured by Defined Daily Dose (DDD) before and after IC bundle implementation
Time frame: Baseline and every 3 months up to 144 weeks
Improvement of process indicators by calculating disinfectant consumption and antibiotic consumption
Improvement of process indicators for the IC (disinfectant consumption) and ABS (antibiotic consumption) bundles by pre-post analysis before implementation of the measures
Time frame: Baseline and every 3 months up to 144 weeks
Effectiveness of ABS interventions by continuously measuring RDDs
Effectiveness of ABS interventions in reducing consumption of antibiotics discouraged for empirical treatment (3rd generation cephalosporins, glycopeptides, carbapenems, daptomycin, tigecycline, and linezolid), measured by Recommended Daily Dose (RDDs) before and after ABS bundle implementation
Time frame: Baseline and every 3 months up to 144 weeks
Antibiotic consumption
Time series analysis using monthly aggregations of antibiotic consumption (RDDs) and incidence of a) CDI, b) VRE, and c) MRGN on participating wards and correlation with IC and ABS intervention activities
Time frame: Baseline and every 3 months up to 144 weeks
Cost-effectiveness by comparing expenditures of implementing IC/ABS measures with reduction in antibiotic consumption
Cost-effectiveness of the different bundles by reducing antibiotic consumption, abbreviating average inpatient stays, and reducing the need for intensive care treatment compared to expenditure for IC and ABS bundle implementation
Time frame: Baseline and after 144 weeks (end of the study)
Plan to share: No — Individual participant data will not be shared after the end of the study
Ran from Nov 2016 to primary completion in Dec 2018, 25 months.
Of 26 observational studies under Clostridium Infections, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University Hospital of Cologne