Cross InfectionNCT07916649
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
An observational study of Cross Infection and Intensive Care Units, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center, retrospective observational study aims to compare the clinical and microbiological characteristics of initial and subsequent healthcare-associated infections (HAIs) in intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection, Intensive Care Units, Microbial Disease
- How many people
- 243 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include adults aged 18 years or older admitted to the Anesthesiology and Reanimation Intensive Care Unit at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between January 1, 2014, and December 31, 2025. Eligible patients must have stayed in the ICU for at least 48 hours and developed at least one healthcare-associated infection (HAI). Patients will be identified retrospectively from hospital records and divided into two cohorts according to the occurrence of a subsequent HAI during the same ICU stay.
Who may be able to join
- Patients aged 18 years or older.
- Admission to the Anesthesiology and Reanimation Intensive Care Unit for at least 48 hours.
- Development of at least one healthcare-associated infection (HAI) during the ICU stay between January 1, 2014, and December 31, 2025.
- Availability of sufficient clinical and infection surveillance records to determine the infection type, diagnosis date, and essential clinical characteristics.
Who cannot join
- Patients younger than 18 years.
- ICU stay shorter than 48 hours.
- Patients with only community-acquired infections who did not develop a healthcare-associated infection during their ICU stay.
- Incomplete clinical, microbiological, or surveillance records required to identify healthcare-associated infections or determine the index infection.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
About this study
Official title: Clinical and Microbiological Comparison of Initial and Subsequent Healthcare-Associated Infections in the Intensive Care Unit
This single-center, retrospective observational study aims to compare the clinical and microbiological characteristics of initial and subsequent healthcare-associated infections (HAIs) in intensive care unit (ICU) patients.
The study will retrospectively review clinical records of adult patients admitted to the Anesthesiology and Reanimation Intensive Care Unit of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between January 1, 2014, and December 31, 2025. Patients aged 18 years or older who stayed in the ICU for at least 48 hours and developed at least one HAI will be eligible for inclusion.
Read more
The first HAI diagnosed during the ICU stay will be defined as the index infection, and the first new HAI occurring thereafter will be classified as the subsequent infection. The Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) 14-day repeat infection timeframe will be considered when identifying distinct infection episodes.
The study will compare clinical characteristics of patients with and without subsequent HAIs. Among patients who develop subsequent infections, changes in infection sites and causative microorganisms will be evaluated, along with the time interval between infection episodes.
All data will be obtained from existing hospital records and infection surveillance databases. No additional diagnostic procedures, treatments, or direct patient contact will be performed.
Read the detailed description
This single-center, retrospective observational study is designed to compare the clinical and microbiological characteristics of initial and subsequent healthcare-associated infections (HAIs) among adult intensive care unit (ICU) patients. The study will be conducted at the Anesthesiology and Reanimation Intensive Care Unit of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Türkiye.
Medical records of patients admitted to the ICU between January 1, 2014, and December 31, 2025, will be retrospectively reviewed. Eligible patients will be aged 18 years or older, have an ICU stay of at least 48 hours, and have developed at least one HAI during hospitalization. Patients with insufficient clinical, microbiological, or infection surveillance records will be excluded. All eligible patient records meeting the study criteria will be considered for inclusion.
The first HAI identified during the ICU stay will be defined as the index infection. The first subsequent HAI meeting the criteria for a new infection episode will be classified as the subsequent infection. To distinguish new infection episodes from the continuation of an existing infection, the 14-day repeat infection timeframe defined by the Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) will be considered. Infections involving different sites and identified on the same date will be recorded as simultaneous multiple HAIs.
Data will be collected from hospital infection surveillance records, electronic medical records, ICU patient files, and microbiology laboratory results. Recorded variables will include demographic characteristics, admission diagnoses, comorbidities, malignancy status, ICU admission dates, infection diagnosis dates, invasive device use, relevant clinical exposures, infection sites, and causative microorganisms.
Two main comparisons will be performed. First, patients will be categorized according to whether they develop a subsequent HAI, and their demographic and clinical characteristics at the time of the index infection will be compared. Only exposures documented at or before the index infection will be considered when examining factors associated with subsequent infection development.
Second, among patients with subsequent HAIs, the index infection and the first subsequent infection will be compared using paired observations. Changes in infection sites and causative microorganisms will be evaluated, and the interval between infection episodes will be calculated in days. Infection-site and microorganism transitions will be summarized using transition tables.
Statistical analyses will include appropriate parametric and nonparametric tests for between-group comparisons and paired categorical analyses for within-patient comparisons. Multivariable logistic regression will be performed to investigate clinical factors independently associated with subsequent HAI development if the number of observed events is sufficient.
The study will use previously collected clinical and microbiological data exclusively. No additional diagnostic procedures, treatments, interventions, or direct patient contact will be required.
- Conditions
- Cross Infection, Intensive Care Units, Microbial Disease
- Medical subject headings
- Cross Infection
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 |
|---|---|---|
| Patients With Subsequent Healthcare-Associated Infections | Adult patients who developed at least one healthcare-associated infection (HAI) during their intensive care unit (ICU) stay and subsequently experienced a new HAI during the same hospitalization. The first HAI will be defined as the index infection, and the first subsequent new HAI will be evaluated according to CDC/NHSN surveillance criteria, including the 14-day repeat infection timeframe. Clinical and microbiological characteristics of the index and subsequent infections will be compared using paired patient data. No study-specific interventions will be performed. | |
| Patients Without Subsequent Healthcare-Associated Infections | Adult patients who developed at least one healthcare-associated infection (HAI) during their intensive care unit (ICU) stay but did not experience a subsequent new HAI during the same hospitalization. The first HAI will be defined as the index infection. Demographic and clinical characteristics at the time of the index infection will be evaluated and compared with those of patients who developed subsequent HAIs. No study-specific interventions will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infection Site Between Index and First Subsequent Healthcare-Associated Infections
Among patients who develop a subsequent healthcare-associated infection (HAI), infection sites will be compared between the index infection and the first subsequent infection using paired patient-level data. Changes in infection sites will be assessed using the number and percentage of patients with different infection sites between episodes. Infection-site distributions and transitions will be presented using frequency tables and transition matrices.
Measured: At diagnosis of the index healthcare-associated infection (baseline) and at diagnosis of the first subsequent healthcare-associated infection during the same ICU stay, assessed up to 120 days after baseline.
Change in Causative Microorganisms Between Index and First Subsequent Healthcare-Associated Infections
Among patients who develop a subsequent healthcare-associated infection (HAI), causative microorganisms identified during the index infection and the first subsequent infection will be compared using paired patient-level data. Changes in causative microorganisms will be evaluated based on microbiological records. The number and percentage of patients with changes in causative microorganisms will be reported, and microorganism transitions will be summarized using frequency distributions and transition tables.
Measured: At diagnosis of the index healthcare-associated infection (baseline) and at diagnosis of the first subsequent healthcare-associated infection during the same ICU stay, assessed up to 120 days after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Oct 2026
- Primary completion23 Oct 2026
- Study completion30 Oct 2026 (estimated)
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 Cross InfectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916649
- Sponsor's protocol ID
- 2026-10/233
- Status last verified
- Nov 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and the sensitive nature of retrospective clinical and microbiological records. Study findings will be reported in aggregate form without identifying individual patients.
Publications
Odoom A, Donkor ES. Prevalence of Healthcare-Acquired Infections Among Adults in Intensive Care Units: A Systematic Review and Meta-Analysis. Health Sci Rep. 2025 Jul 9;8(7):e70939. doi: 10.1002/hsr2.70939. eCollection 2025 Jul.
PubMed 40636544Rodriguez-Acelas AL, de Abreu Almeida M, Engelman B, Canon-Montanez W. Risk factors for health care-associated infection in hospitalized adults: Systematic review and meta-analysis. Am J Infect Control. 2017 Dec 1;45(12):e149-e156. doi: 10.1016/j.ajic.2017.08.016. Epub 2017 Oct 12.
PubMed 29031433Isonne C, Baccolini V, Migliara G, Ceparano M, Alessandri F, Ceccarelli G, Tellan G, Pugliese F, De Giusti M, De Vito C, Marzuillo C, Villari P, Barone LC, Giannini D, Marotta D, Marte M, Mazzalai E, Germani I, Bellini A, Bongiovanni A, Castellani M, D'Agostino L, De Giorgi A, De Marchi C, Mazzeo E, Orlandi S, Piattoli M, Ricci E, Siena LM, Territo A, Zanni S. Comparing the Occurrence of Healthcare-Associated Infections in Patients with and without COVID-19 Hospitalized during the Pandemic: A 16-Month Retrospective Cohort Study in a Hospital Intensive Care Unit. J Clin Med. 2022 Mar 7;11(5):1446. doi: 10.3390/jcm11051446.
PubMed 35268538
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Comparison of Initial and Subsequent Healthcare-Associated Infections in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07916649
- Acronym / sponsor ID
- 2026-10/233
- Conditions
- Cross Infection, Intensive Care Units, Microbial Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 23 Oct 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 4 Nov 2026 (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.
This single-center, retrospective observational study aims to compare the clinical and microbiological characteristics of initial and subsequent healthcare-associated infections (HAIs) in intensive care unit (ICU) patients.
The study will retrospectively review clinical records of adult patients admitted to the Anesthesiology and Reanimation Intensive Care Unit of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between January 1, 2014, and December 31, 2025. Patients aged 18 years or older who stayed in the ICU for at least 48 hours and developed at least one HAI will be eligible for inclusion.
The first HAI diagnosed during the ICU stay will be defined as the index infection, and the first new HAI occurring thereafter will be classified as the subsequent infection. The Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) 14-day repeat infection timeframe will be considered when identifying distinct infection episodes.
The study will compare clinical characteristics of patients with and without subsequent HAIs. Among patients who develop subsequent infections, changes in infection sites and causative microorganisms will be evaluated, along with the time interval between infection episodes.
All data will be obtained from existing hospital records and infection surveillance databases. No additional diagnostic procedures, treatments, or direct patient contact will be performed.
Detailed description
This single-center, retrospective observational study is designed to compare the clinical and microbiological characteristics of initial and subsequent healthcare-associated infections (HAIs) among adult intensive care unit (ICU) patients. The study will be conducted at the Anesthesiology and Reanimation Intensive Care Unit of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Türkiye.
Medical records of patients admitted to the ICU between January 1, 2014, and December 31, 2025, will be retrospectively reviewed. Eligible patients will be aged 18 years or older, have an ICU stay of at least 48 hours, and have developed at least one HAI during hospitalization. Patients with insufficient clinical, microbiological, or infection surveillance records will be excluded. All eligible patient records meeting the study criteria will be considered for inclusion.
The first HAI identified during the ICU stay will be defined as the index infection. The first subsequent HAI meeting the criteria for a new infection episode will be classified as the subsequent infection. To distinguish new infection episodes from the continuation of an existing infection, the 14-day repeat infection timeframe defined by the Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) will be considered. Infections involving different sites and identified on the same date will be recorded as simultaneous multiple HAIs.
Data will be collected from hospital infection surveillance records, electronic medical records, ICU patient files, and microbiology laboratory results. Recorded variables will include demographic characteristics, admission diagnoses, comorbidities, malignancy status, ICU admission dates, infection diagnosis dates, invasive device use, relevant clinical exposures, infection sites, and causative microorganisms.
Two main comparisons will be performed. First, patients will be categorized according to whether they develop a subsequent HAI, and their demographic and clinical characteristics at the time of the index infection will be compared. Only exposures documented at or before the index infection will be considered when examining factors associated with subsequent infection development.
Second, among patients with subsequent HAIs, the index infection and the first subsequent infection will be compared using paired observations. Changes in infection sites and causative microorganisms will be evaluated, and the interval between infection episodes will be calculated in days. Infection-site and microorganism transitions will be summarized using transition tables.
Statistical analyses will include appropriate parametric and nonparametric tests for between-group comparisons and paired categorical analyses for within-patient comparisons. Multivariable logistic regression will be performed to investigate clinical factors independently associated with subsequent HAI development if the number of observed events is sufficient.
The study will use previously collected clinical and microbiological data exclusively. No additional diagnostic procedures, treatments, interventions, or direct patient contact will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Subsequent Healthcare-Associated Infections | – | –Adult patients who developed at least one healthcare-associated infection (HAI) during their intensive care unit (ICU) stay and subsequently experienced a new HAI during the same hospitalization. The first HAI will be defined as the index infection, and the first subsequent new HAI will be evaluated according to CDC/NHSN surveillance criteria, including the 14-day repeat infection timeframe. Clinical and microbiological characteristics of the index and subsequent infections will be compared using paired patient data. No study-specific interventions will be performed. |
| Patients Without Subsequent Healthcare-Associated Infections | – | –Adult patients who developed at least one healthcare-associated infection (HAI) during their intensive care unit (ICU) stay but did not experience a subsequent new HAI during the same hospitalization. The first HAI will be defined as the index infection. Demographic and clinical characteristics at the time of the index infection will be evaluated and compared with those of patients who developed subsequent HAIs. No study-specific interventions will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults aged 18 years or older admitted to the Anesthesiology and Reanimation Intensive Care Unit at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between January 1, 2014, and December 31, 2025. Eligible patients must have stayed in the ICU for at least 48 hours and developed at least one healthcare-associated infection (HAI). Patients will be identified retrospectively from hospital records and divided into two cohorts according to the occurrence of a subsequent HAI during the same ICU stay.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older.
- Admission to the Anesthesiology and Reanimation Intensive Care Unit for at least 48 hours.
- Development of at least one healthcare-associated infection (HAI) during the ICU stay between January 1, 2014, and December 31, 2025.
- Availability of sufficient clinical and infection surveillance records to determine the infection type, diagnosis date, and essential clinical characteristics.
Key exclusion criteria (4 listed)
- Patients younger than 18 years.
- ICU stay shorter than 48 hours.
- Patients with only community-acquired infections who did not develop a healthcare-associated infection during their ICU stay.
- Incomplete clinical, microbiological, or surveillance records required to identify healthcare-associated infections or determine the index infection.
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
Change in Infection Site Between Index and First Subsequent Healthcare-Associated Infections
Time frame: At diagnosis of the index healthcare-associated infection (baseline) and at diagnosis of the first subsequent healthcare-associated infection during the same ICU stay, assessed up to 120 days after baseline.
Among patients who develop a subsequent healthcare-associated infection (HAI), infection sites will be compared between the index infection and the first subsequent infection using paired patient-level data. Changes in infection sites will be assessed using the number and percentage of patients with different infection sites between episodes. Infection-site distributions and transitions will be presented using frequency tables and transition matrices.
Change in Causative Microorganisms Between Index and First Subsequent Healthcare-Associated Infections
Time frame: At diagnosis of the index healthcare-associated infection (baseline) and at diagnosis of the first subsequent healthcare-associated infection during the same ICU stay, assessed up to 120 days after baseline.
Among patients who develop a subsequent healthcare-associated infection (HAI), causative microorganisms identified during the index infection and the first subsequent infection will be compared using paired patient-level data. Changes in causative microorganisms will be evaluated based on microbiological records. The number and percentage of patients with changes in causative microorganisms will be reported, and microorganism transitions will be summarized using frequency distributions and transition tables.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 40636544Odoom A, Donkor ES. Prevalence of Healthcare-Acquired Infections Among Adults in Intensive Care Units: A Systematic Review and Meta-Analysis. Health Sci Rep. 2025 Jul 9;8(7):e70939. doi: 10.1002/hsr2.70939. eCollection 2025 Jul.
- Background: PubMed 29031433Rodriguez-Acelas AL, de Abreu Almeida M, Engelman B, Canon-Montanez W. Risk factors for health care-associated infection in hospitalized adults: Systematic review and meta-analysis. Am J Infect Control. 2017 Dec 1;45(12):e149-e156. doi: 10.1016/j.ajic.2017.08.016. Epub 2017 Oct 12.
- Background: PubMed 35268538Isonne C, Baccolini V, Migliara G, Ceparano M, Alessandri F, Ceccarelli G, Tellan G, Pugliese F, De Giusti M, De Vito C, Marzuillo C, Villari P, Barone LC, Giannini D, Marotta D, Marte M, Mazzalai E, Germani I, Bellini A, Bongiovanni A, Castellani M, D'Agostino L, De Giorgi A, De Marchi C, Mazzeo E, Orlandi S, Piattoli M, Ricci E, Siena LM, Territo A, Zanni S. Comparing the Occurrence of Healthcare-Associated Infections in Patients with and without COVID-19 Hospitalized during the Pandemic: A 16-Month Retrospective Cohort Study in a Hospital Intensive Care Unit. J Clin Med. 2022 Mar 7;11(5):1446. doi: 10.3390/jcm11051446.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and the sensitive nature of retrospective clinical and microbiological records. Study findings will be reported in aggregate form without identifying individual patients.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cross Infection and Intensive Care Units, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Infection Site Between Index and First Subsequent Healthcare-Associated Infections (time frame: At diagnosis of the index healthcare-associated infection (baseline) and at diagnosis of the first subsequent healthcare-associated infection during the same ICU stay, assessed up to 120 days after baseline.). 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 NCT07916649, 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 4 Nov 2026.