Candida OsteomyelitisNCT06788782
Analysis of Candida-Associated Osteoarticular Infections: Multicenter Turkish Data
An observational study of Candida Osteomyelitis and Candida Infection, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida Osteomyelitis, Candida Infection, Arthritis
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2024to 23 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pediatric patients
- Patients with Candida spp. growth in superficial tissue culture will not be part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Candida-associated Osteoarticular Infections: Multicenter Data From Turkey
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.
Read the 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.
- Conditions
- Candida Osteomyelitis, Candida Infection, Arthritis, Spondylodiskitis
- Medical subject headings
- Candidiasis, Arthritis, Discitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start5 Dec 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Candida OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University
- Responsible party
- Principal investigator, Özlem Güler, Kocaeli University
- Investigators
- Özlem Güler, Asst. Prof., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788782
- Sponsor's protocol ID
- GOKAEK-2024/04.05 2024/40
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared with infectious disease physicians and academics for a period of two years following the release of the study protocol
Publications
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.
PubMed 22911646Gamaletsou 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.
PubMed 26858961Pappas 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.
PubMed 26679628
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Candida-associated Osteoarticular Infections: Multicenter Data From Turkey
- ClinicalTrials.gov ID
- NCT06788782
- Acronym / sponsor ID
- GOKAEK-2024/04.05 2024/40
- Conditions
- Candida Osteomyelitis, Candida Infection, Arthritis, Spondylodiskitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Istinye University
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pediatric patients
- Patients with Candida spp. growth in superficial tissue culture will not be part of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The aim of this study was to evaluate the clinical findings of patients with Candida osteoarticular infection.
Time frame: 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
Time frame: 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.
1 secondary outcome
Treatment success of Candida osteoarticular infections
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 22911646Gamaletsou 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.
- Background: PubMed 26858961Gamaletsou 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.
- Background: PubMed 26679628Pappas 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.
- Individual participant dataSharing planned: Yes. Data may be shared with infectious disease physicians and academics for a period of two years following the release of the study protocol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Güler, Asst. Prof. principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida Osteomyelitis and Candida Infection, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this study was to evaluate the clinical findings of patients with Candida osteoarticular infection. (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788782, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.