Clinical trial NCT06788782: Analysis of Candida-Associated Osteoarticular Infections: Multicenter Turkish Data
Official title: Retrospective Analysis of Candida-associated Osteoarticular Infections: Multicenter Data From Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candida Osteomyelitis
Candida Infection
Arthritis
Spondylodiskitis
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Istinye University
First posted: 2025-01-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The aim of this study was to evaluate the clinical findings of patients with Candida osteoarticular infection.
timeFrame: 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.
measure: Microbiological Characteristics of Candida species
timeFrame: 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:
measure: Treatment success of Candida osteoarticular infections
timeFrame: 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:
measure: Factors affecting treatment success
timeFrame: 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
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Özlem Güler, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.