Blood Stream InfectionsNCT07884942
Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates
An observational study of Blood Stream Infections and Adult Cancer Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Sepsis and bloodstream infection (BSI) are among the most serious complications in patients with cancer, in whom disease- and treatment-related immunosuppression markedly increases susceptibility to infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Blood Stream Infections, Adult Cancer Patients
- What is being tested?
- Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity and Molecular characterization of bacterial isolates
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Cancer Patients with Blood Stream Infection
Who may be able to join
- o Adult patients (≥18 years) with a confirmed diagnosis of solid or hematological malignancy.
- Laboratory-confirmed bloodstream infection (at least one positive blood culture with a clinically significant pathogen).
Who cannot join
- o Patients younger than 18 years.
- Patients without confirmed malignancy (e.g., benign tumors, suspected but unconfirmed cancer).
- Blood cultures with suspected contamination (e.g., common skin commensals such as coagulase-negative Staphylococci isolated without clinical significance).
- Duplicate episodes: repeated positive cultures from the same patient with the same organism within the same infectious episode (only the first isolate is included).
- Bloodstream infections that are not bacterial (e.g., fungal or viral only).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Gamal Abdelnasser Abass Khalifa Dr Mai Khalifa, Assistant lecturer of Medical contact
Egypt1 site
Sohag University Hospitals
Sohag
Mai Dr Mai Khalifa, Assistant Lecturer, +201068298408, maigamal@med.sohag.edu.eg
About this study
Official title: Prediction of Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates in Adult Cancer Patients With Blood Stream Infection.
Sepsis and bloodstream infection (BSI) are among the most serious complications in patients with cancer, in whom disease- and treatment-related immunosuppression markedly increases susceptibility to infection. Sepsis accounts for approximately 15% of ICU admissions in this population, and short-term mortality is consistently higher than in patients without cancer In haematological malignancy, sepsis affects roughly 12-27% of patients within a year of diagnosis, and although in-hospital mortality has fallen over two decades, it remained higher than in non-cancer patients (23.1% vs 14.4% in 2021) .
Read the detailed description
BSI in these patients is often complicated by polymicrobial infection and multidrug-resistant organisms, which are associated with worse outcomes, and early identification of high-risk patients is therefore essential to optimize empirical therapy and guide escalation of care. Because blood culture results take days, the outcome of an episode depends largely on the quality of the empirical antibiotic choice made before the pathogen and its susceptibility are known.
That choice is becoming progressively harder because of antimicrobial resistance (AMR), one of the most serious global health threats of the 21st century. The spread of multidrug-resistant organisms, such as ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), and methicillin-resistant Staphylococcus aureus (MRSA), has narrowed the reliable options for empirical treatment.
Clinicians usually rely on local antibiograms, guidelines, and personal experience, which do not capture patient-specific risk factors or rapidly changing resistance patterns at the ward level. Consequently, regimens tend to be either too broad, driving further resistance, or too narrow, risking treatment failure, and inappropriate empirical therapy is consistently associated with higher mortality in bacteraemia.
Phenotypic susceptibility testing tells us whether an isolate is resistant, but not why. Molecular characterization of resistant isolates identifies the underlying genes and lineages and can explain the predicted phenotype. For instance, whole-genome sequencing of CRE bloodstream isolates from patients with hematological malignancies showed a predominance of ST11 and blaKPC-2 among carbapenem-resistant Klebsiella pneumoniae. Linking clinical prediction with genomic data could therefore make a predictive model more interpretable and more useful for surveillance.
- Conditions
- Blood Stream Infections, Adult Cancer Patients
- Being tested
- Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity, Molecular characterization of bacterial isolates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivityDiagnostic test
Blood Culture: Blood samples will be collected under complete aseptic conditions. Blood culture bottles will immediately be transported to the Medical Microbiology Laboratory and tested using the BD BACTEC blood culture system.
Identification and antibiotic sensitivity of bacterial isolates: Positive blood culture bottles will be identified and tested for antimicrobial sensitivity using the VITEK® 2 Compact system (bioMérieux, France).
Molecular characterization of bacterial isolatesDiagnostic test
A subset of bacterial isolates collected during the prospective phase will undergo molecular characterization to enable integration of molecular resistance determinants with clinical and laboratory variables.
| Study group | Role | What they receive |
|---|---|---|
| Adult Cancer Patients with Blood Stream Infection | Adult cancer patients with blood stream infections Receives: Diagnostic Test: Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity; Diagnostic Test: Molecular characterization of bacterial isolates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity
Blood Culture: BD BACTEC blood culture system. Identification and antibiotic sensitivity of bacterial isolates: VITEK® 2 Compact system (bioMérieux, France).
Measured: From enrollment up to 6 months.
Molecular characterization of bacterial isolates
A subset of bacterial isolates collected during the prospective phase will undergo molecular characterization to enable integration of molecular resistance determinants with clinical and laboratory variables.
Measured: From the end of enrollment up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Stream InfectionsStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Gamal Abdelnasser Abass Khalifa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884942
- Sponsor's protocol ID
- Soh-Med--26-10-2MD
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bianchi A, Mokart D, Leone M. Cancer and sepsis: future challenges for long-term outcome. Curr Opin Crit Care. 2024 Oct 1;30(5):495-501. doi: 10.1097/MCC.0000000000001173. Epub 2024 May 31.
PubMed 38841906Bachlitzanaki M, Aletras G, Ioannou P, Bachlitzanaki E, Hamilos G, Samonis G, Kofteridis D. Bloodstream Infections in Solid Malignancies: Risk Factors, Resistance Patterns, and Clinical Outcomes from a Two-Center Cohort in Heraklion, Crete. Life (Basel). 2026 Apr 24;16(5):720. doi: 10.3390/life16050720.
PubMed 42195276