Analysis of Candida-Associated Osteoarticular Infections: Multicenter Turkish Data

NCT06788782 | Completed

• 1 other identifier: GOKAEK-2024/04.05 2024/40
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study was to retrospectively analyze the osteoarticular infections caused by Candida spp. in adult patients in Turkey during the last decade and to determine the distribution of causative agents, demographic data, risk factors, clinical, radiological and laboratory findings. It was also aimed to compare treated and untreated cases and to reveal the factors influencing the success of treatment.

Conditions

Candida Osteomyelitis; Candida Infection; Arthritis; Spondylodiskitis

Outcome Measures

Primary Outcomes (2)

• The aim of this study was to evaluate the clinical findings of patients with Candida osteoarticular infection.

  Description This outcome measure aims to assess the findings of cases of Candida osteoarticular infection. Four specific findings will be inquired about. Pain, swelling, redness, and purulent discharge. Measurement Tool/Method: Clinical findings will be assessed using a patient chart review form. Unit of Measure: Each clinical finding will be expressed as a percentage.

  Data will be collected retrospectively by reviewing the files of cases diagnosed in the last ten years (between 1 January 2014 and 1 December 2024) (last 10 years). Review of files and enrollment of cases into the study started on 5 December 2024.

• Microbiological Characteristics of Candida species

  Description: This outcome measure aims to describe the microbiological profiles of Candida osteoarticular infections Measure Description Fungal culture results by VITEC-2 or MALDI-TOF will be evaluated. Unit of measurement: Percentage of Candida species detected.

  Data will be collected retrospectively by reviewing the files of cases diagnosed in the last ten years (between 1 January 2014 and 1 December 2024) (last 10 years). Review of files and enrollment of cases into the study started on 5 December 2024.

Secondary Outcomes (1)

• Treatment success of Candida osteoarticular infections

  Data will be collected retrospectively by reviewing the files of cases diagnosed in the last ten years (between 1 January 2014 and 1 December 2024) (last 10 years). Review of files and enrollment of cases into the study started on 5 December 2024.

Other Outcomes (1)

• Factors affecting treatment success

  Data will be collected retrospectively by reviewing the files of cases diagnosed in the last ten years (between January 1, 2014, and December 1, 2024) (the last 10 years). The review of files and the enrollment of cases into the study by invitation began

Study Arms (1)

Candida osteoarticular infections

Patients with an osteoarticular infection diagnosed on the basis of Candida growth in deep tissue culture, bone or joint fluid, and clinical and radiologic findings.

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

Since it is a rare disease, all cases reported from various centers in Turkey will be included. Efforts will be made to reach as many centers as possible through the mailing lists.

You may qualify if:

• Patients over 18 years of age
• Cases of osteomyelitis, septic arthritis and spondylodiscitis due to Candida spp.
• Deep tissue culture, joint fluid or bone tissue growth is required. In addition, patients with compatible clinical and radiographic findings will be enrolled.

You may not qualify if:

• Pediatric patients
• Patients with Candida spp. growth in superficial tissue culture will not be part of the study.

Sponsors & Collaborators

• Kocaeli University: lead
• Istinye University: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (3)

• Gamaletsou MN, Kontoyiannis DP, Sipsas NV, Moriyama B, Alexander E, Roilides E, Brause B, Walsh TJ. Candida osteomyelitis: analysis of 207 pediatric and adult cases (1970-2011). Clin Infect Dis. 2012 Nov 15;55(10):1338-51. doi: 10.1093/cid/cis660. Epub 2012 Aug 21.

  PMID: 22911646 BACKGROUND

• Gamaletsou MN, Rammaert B, Bueno MA, Sipsas NV, Moriyama B, Kontoyiannis DP, Roilides E, Zeller V, Taj-Aldeen SJ, Miller AO, Petraitiene R, Lortholary O, Walsh TJ. Candida Arthritis: Analysis of 112 Pediatric and Adult Cases. Open Forum Infect Dis. 2015 Dec 23;3(1):ofv207. doi: 10.1093/ofid/ofv207. eCollection 2016 Jan.

  PMID: 26858961 BACKGROUND

• Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, Reboli AC, Schuster MG, Vazquez JA, Walsh TJ, Zaoutis TE, Sobel JD. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Feb 15;62(4):e1-50. doi: 10.1093/cid/civ933. Epub 2015 Dec 16.

  PMID: 26679628 BACKGROUND

MeSH Terms

Conditions

Candidiasis; Arthritis; Discitis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Joint Diseases; Musculoskeletal Diseases; Spondylitis; Bone Diseases, Infectious; Bone Diseases; Spinal Diseases

Study Officials

• Özlem Güler, Asst. Prof.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor M.D.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 23, 2025
• Study Start: December 5, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data can be shared for two years after study protocol release
• Access Criteria: Infectious disease physicians access is appropriate

Locations

TU (1)