Analysis of Candida-Associated Osteoarticular Infections: Multicenter Turkish Data

Completed

• Conditions: Arthritis; Candida Osteomyelitis; Candida Infection; Spondylodiskitis

• Registration Number: NCT06788782
• Lead Sponsor: Kocaeli University

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.

Detailed Description

Osteoarticular infections caused by Candida species can cause serious morbidity if not diagnosed and treated early. There are two large reviews of osteomyelitis and arthritis cases in the literature, and other data on the disease are based on case reports or small case series. Treatment recommendations for rare infections, such as Candida-associated osteomyelitis, are based on small case series and case reports from randomized clinical trials designed on other clinical forms of the disease. Amphotericin B is the most commonly used treatment of choice; however, recent reports suggest that fluconazole or echinocandin may be used. There are case reports in Turkey, but no multicenter study data have been reported.

The aim of this retrospective observational study was to investigate the osteoarticular infections caused by Candida spp. in Turkey, to reveal the distribution of causative agents, demographic data, risk factors, clinical, radiologic and laboratory findings, and to contribute to the literature with the data to be obtained at the end of the study in the management of these infections by comparing successful and unsuccessful cases in treatment.

It was planned to share the Excel file prepared by the principal investigator containing the data to be collected via e-mail, and to evaluate all the data after collection via e-mail.

Statistical evaluation will be performed using IBM SPSS (version 29.0; IBM Corp., Armonk, NY, USA). Chi-square and Fisher's exact tests will be used to compare the categorical variables. The conformity of measurement variables to normal distribution will be examined by Kolmogorov-Smirnov test. Descriptive analyses will be presented using the mean, standard deviation, median, and minimum-maximum values. Risk factors for treatment failure or side effects will be evaluated using the Mann-Whitney U test or Student's t-test. Treatment failure will be considered the dependent variable and will be analyzed using univariate logistic regression with other variables. A P value \< 0.05 will be considered significant. In a stepwise approach, the variables found to be significant in the univariate logistic regression test will be analyzed using multivariate logistic regression analysis.

Study Timeline

• Study First Submitted: 2024-12-04
• Study Start: 2024-12-05
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-23
• Status Verified: 2025-04
• Primary Completion: 2025-04-23
• Study Completion: 2025-04-23
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study was to evaluate the clinical findings of patients with Candida osteoarticular infection.	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.	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.
Microbiological Characteristics of Candida species	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	This outcome measure investigates the success rate of treatment strategies for Candida osteoarticular infections. Treatment success is defined as resolution of symptoms, eradication of infection, and no recurrence within 6 months after completing therapy.; Measurement Tool/Method: Success will be assessed based on follow-up clinical evaluations and microbiological clearance confirmed by repeat cultures.; Unit of Measure: Percentage of participants achieving treatment success.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey