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Trial record 27 of 4181 for:    Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption

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ClinicalTrials.gov Identifier: NCT03717090
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Chih Kuo, Chang Gung Memorial Hospital

Brief Summary:

This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room.

The purpose of this study will be to evaluate that 1) the concordance of organism identification by the direct identification of MALTI-TOF MS versus routine identification of MALTI-TOF MS and conventional cultures and 2) the timing of preliminary strain identification by the direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures in patients with periprosthetic joint infection.


Condition or disease Intervention/treatment
Prosthetic Joint Infection Other: No intervention

Detailed Description:

Material and Methods

  1. Patients who have a high probability of infection based on the Musculoskeletal Infection Society (MSIS) criteria and are scheduled for debridement only or debridement with implant removal, will be invited to enroll the study after signed informed consent.

    The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 ccs. The sample will be divided between MALDI-TOF mass spectrometry in standard blood culture bottles (10 ccs), wound culture tube (2 ccs), and synovial fluid analysis (2 ccs). The samples will be delivered to microbiology laboratory within a 2-hour period.

  2. Bacterial culture and conventional identification Bacterial identification will be performed by the conventional method using the Vitek 2 system. For the conventional culture, 1 µL of well-mixed synovial joint fluid will be inoculated and spread onto blood agar plates and MacConkey agar plates using a sterile plastic disposable loop. Plates will be incubated in an aerobic atmosphere at 37℃ for 18-24 hr. When bacterial growth is observed, the colonies on blood agar will be counted, and colonies from both types of plates will be identified by using the Vitek 2 system.
  3. MALDI-TOF MS identification The suspension obtained following the above sample preparation will be centrifuged at 13,000g for 2 minutes, and the supernatant will be discarded. The pellet will be centrifuged at 13,000g for another 2 minutes prior to the removal of the residual ethanol. Fifty microliters of formic acid (70% v/v) and 50 mL of 100% acetonitrile will be added to the pellet, and mixed thoroughly after each reagent is added. The suspension will be centrifuged again at 13,000g for another 2 minutes, and 1 mL of the supernatant will be spotted onto the steel target plate. Analysis will be performed following air-drying of 1 mL a-cyano-4-hydroxycinnamic acid matrix solution placed onto the dried sample spot in duplicate.

    Mass spectra profiles will be acquired using a microflex LT MALDI-TOF mass spectrometer (Bruker Daltonics, Bremen, Germany) following the manufacturer's settings. Spectra will be recorded in the linear positive mode at a laser frequency of 60 Hz within a mass range from 2000 Da to 20,000 Da. All bacteria identifications will be performed by MALDI-TOF Biotyper RTC and the Bruker MALDI Biotyper 3.1 software and library (4613 isolates; Bruker Daltonics). Criteria used for microorganism analysis and identification will be as recommended by the manufacturer.

  4. Statistical analysis Time to identification will be determined as the time from colony formation to the time at which the final result is reported to a physician. Statistical analysis will be performed to compare the three methods using Chi-square tests. The level of statistical significance will be set at p < 0.05.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption Ionization Time-of-flight Mass Spectrometry
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with PJI Other: No intervention
Sample collection study Sample collection and collection of laboratory values




Primary Outcome Measures :
  1. The identification rate of microorganisms [ Time Frame: Immediate post-operative period (usually within 5-7 days following surgery) ]
    The organism identification from direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures


Secondary Outcome Measures :
  1. The timing of organism identification [ Time Frame: Immediate post-operative period (usually within 5-7 days following surgery) ]
    The timing of preliminary strain identification of direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 cc. The sample was partitioned between two set of aerobic and anaerobic BCBs (at least 2.5cc for each bottle), wound culture tube (2cc), synovial fluid analysis (2cc). In instances where there is insufficient fluid to send all 3 modalities (less than 14 mL), patients will be excluded from the current investigation. Samples will be delivered to the clinical microbiology laboratory within a 2-hour period.
Criteria

Inclusion Criteria: high probability of infection based on the Musculoskeletal Infection Society (MSIS) criteria and will be scheduled for debridement only or debridement with implant removal

Exclusion Criteria:

  • Patients not meeting MSIS criteria
  • Patients undergoing aseptic revision
  • Insufficient synovial fluid amount for analysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717090


Contacts
Contact: Feng-Chih Kuo, MD 886-7-7317123 fongchikuo@cgmh.org.tw

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Feng-Chih Kuo, MD    886-7-7317123    fongchikuo@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Feng-Chih Kuo, MD Chang Gung Memorial Hospital

Publications:

Responsible Party: Feng Chih Kuo, Assistant professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03717090     History of Changes
Other Study ID Numbers: CMRPG8F1402
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Feng Chih Kuo, Chang Gung Memorial Hospital:
mass spectrometry, diagnosis, prosthetic joint infection, matrix-assisted laser desorption ionization

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases