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Not yet recruitingNCT07884942Updated Oct 23, 2026

Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates

An observational study in Blood Stream Infections and Adult Cancer Patients, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Sohag University · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Blood Stream Infections
  • Adult Cancer Patients
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult Cancer Patients with Blood Stream Infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adult Cancer Patients with Blood Stream Infection

    Adult cancer patients with blood stream infections

    Diagnostic Test: Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity · Diagnostic Test: Molecular characterization of bacterial isolates

Interventions

  • Diagnostic testIdentification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity

    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).

  • Diagnostic testMolecular 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: From enrollment up to 6 months.

  2. 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.

    Time frame: From the end of enrollment up to 6 months.

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Study locations

1 site
  • Sohag University Hospitals
    Sohag, Egypt
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References and documents

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 38841906 ↗
  • Bachlitzanaki 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 ↗

Individual participant data

Plan to share: No

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Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 21, 2026
StartEst.
Nov 2026
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 2 updates
  1. Oct 23, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07884942
Lead sponsor
Sohag University
Responsible party
Mai Gamal Abdelnasser Abass Khalifa (Assistant lecturer of Medical Microbiology and Immunology Faculty of Medicine, Sohag University, Sohag University) — Principal investigator
First posted
Oct 21, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Mai Gamal Abdelnasser Abass Khalifa Dr Mai Khalifa, Assistant lecturer of Medical
Contact
maigamal@med.sohag.edu.eg
01068298408

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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