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Clinical Trials in Egypt / NCT07884942
Starting soon Observational

Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates

NCT07884942 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Observational
Started
2026-11
Last updated
2026-10-23

Condition(s) studied

Blood Stream InfectionsAdult Cancer Patients

Investigational drug(s) / intervention(s)

Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivityMolecular characterization of bacterial isolates

Identification 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).

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.

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) .

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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: * 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).

Primary outcome measure(s)

  • Identification of bacterial isolates causing blood stream infection and determination of their antibiotic sensitivity — From enrollment up to 6 months.
    Blood Culture: BD BACTEC blood culture system. Identification and antibiotic sensitivity of bacterial isolates: VITEK® 2 Compact system (bioMérieux, France).
  • Molecular characterization of bacterial isolates — From the end of enrollment up to 6 months.
    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.

Trial sites (1)

FacilityCityRegionStatus
Sohag University Hospitals Sohag Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07884942 on ClinicalTrials.gov ↗ ← All trials in Egypt