BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections

NCT02222792 | Unknown

• 1 other identifier: BJI 2
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 2

Brief Summary

A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach. Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.

Conditions

Bone and Joint Prosthetic Infections

Keywords

Staphylococci, Streptococci, P acnes and Gram-negative bacteria

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of test BJI 2

  The diagnostic performance of the test during unique titration. * Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration. * Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration. * Positive likelihood ratio. * Negative likelihood ratio.

  2 years

Secondary Outcomes (1)

• Interest of test BJI 2

  2 years

Study Arms (3)

Septic patient group

The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).

Non-septic patient group

The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative

Intermediate group

An intermediate group will be comprised of patients with only one deep positive sample.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain). The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative.

You may qualify if:

• Male or female patients
• Patients 18 years of age or older
• Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)
• Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not
• Patients who have not expressed their opposition to the use of their personal medical data and blood samples

You may not qualify if:

• Patients already enrolled or clinically reviewed following a relapse
• Patients with several prostheses requiring at least two revisions during the same surgical procedure
• Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study
• HIV+ patients
• Patients undergoing chemotherapy for a blood disease or solid tumour
• Patients under guardianship or trusteeship
• Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)

Sponsors & Collaborators

• Diaxonhit: lead

Study Sites (2)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, 75012, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serologic assays of sera collected from septic or non-septic patients will be performed in series and operators will be blind in terms of clinical and microbiological status in order to avoid any interpretation bias due to information collected in advance

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: June 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2016
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

FR (2)