Clinical Priority Program-Bone Infection Registry

Staphylococcus Aureus Clinical Trial

— CPPInfection  

Official title:

Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677000
• Other study ID #: CPP Infection Registry
• Status: Completed
• Start date: June 2012
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include:

1. baseline patient attributes;

2. surgical approach, implants and technology;

3. hospital course;

4. surgeon and institutional characteristics;

5. longitudinal patient outcome,

6. post-procedure complications and revisions,

7. serum/tissue/drainage samples.

Description:

Establish an international registry with AOCID of over 400 patients with deep infections involving the bone and/or joint from ≥ 20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal infection cases will permit better analysis of the causes, contributing factors including patient immune responses, treatments and clinical outcomes of musculoskeletal infections.

• Establish a practice network that includes ≥ 20 geographically distributed centers. These busy practices will be treating patients with varied geographic status to assure balanced representation of diverse patients and practices.

• Establish a Data Coordinating Core team with AOCID using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry.

The registry will include:

• baseline patient attributes

• surgical approach, implants and technology

• hospital course

• surgeon and institutional characteristics

• longitudinal patient outcome

• post-procedure complications and revisions

• serum/tissue/drainage samples

• Establish a Statistical Support team with AOCID to implement cutting-edge statistical techniques including the use of hierarchical generalized linear latent and mixed effects models to address the complex structure and longitudinal nature of registry data. Multivariable predictive models for outcome(s) of infection will be developed.

• Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP team to advance the science of infection-specific and global patient-reported outcomes to support efficient data collection of web-based, longitudinal data in this registry and future comparative effectiveness research.

• Develop new assessment tools and conduct research useful to clinical practice. Establish consensus on the definition of treatment failure- characterized as lack of clinically meaningful improvement in infection, pain or physical function following treatment, validate, and refine prediction algorithms for patients at risk for failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older

• Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a combination) of the following:

• Osteomyelitis

• Fracture fixation hardware /prosthetic joint infection

• Infection around an arthroplasty

• Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation

• Signed written informed consent * Confirmed either by positive culture from baseline examination or by positive culture from a prior examination of the same surgical site and definitely ongoing infection with Staphylococcus aureus according to the treating surgeon

Exclusion Criteria:

• Patients who cannot give informed consent

• Patients who cannot attend the follow up visits

• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

• Prisoner

Related Conditions & MeSH terms

• Bone Infection
• Communicable Diseases
• Infection
• Osteomyelitis
• Staphylococcus Aureus

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Austria	Medizinische Universitaetsklinik Innsbruck	Innsbruck
Belgium	Universitair Ziekenhuis Leuven	Leuven
Canada	Foothills Medical Centre	Calgary	Alberta
China	Beijing University Third Hospital	Beijing
China	Southwestern Hospital Chongqing	Chongqing	Chongqing
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Queen Mary Hospital	Hong Kong
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou
Denmark	Aarhus University Hospital	Aarhus
Germany	Justus-Liebig-Universität	Giessen
Germany	Berufsgenossenschaftliche Unfallklinik Murnau	Murnau am Staffelsee	Bavaria
Germany	Universitaetsklinikum Regensburg	Regensburg
Japan	Hamawaki Orthopaedic Hospital	Hiroshima
Japan	Hokkaido University Graduate School of Medicine	Sapporo	Hokkaido
Switzerland	Universitätsspital Basel	Basel	Basel Stadt
United States	University of Missouri Health Care	Columbia	Missouri
United States	Geisinger Health System	Danville	Pennsylvania
United States	University of Richmond, Department of Orthopaedic Surgery	Richmond	Virginia
United States	Unity Hospital	Rochester	New York
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  China,  Denmark,  Germany,  Japan,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Details on occurence and treatment of bone infection		1 December 2012
Secondary	Surgical approach, implants and technology		01 December 2012
Secondary	Patient outcome		01 December 2012
Secondary	Post-procedure complications and revisions		01 December 2012