Molecular Characterization of Carbapenemase-Producing Enterobacterales

NCT07116356 | Not Yet Recruiting

• 1 other identifier: Soh-Mmed-25-7-10PD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bacterial infections with carbapenem resistant pathogens are one of the major threats in immunocompromised patients, especially among cancer patients .Furthermore, Gram negative pathogens are becoming increasingly prevalent and have become an ongoing global health concern .Emergence of Gram-negative pathogens, especially Enterobacterales that avert many of the human defense mechanisms are alarmingly increasing and most of these pathogens are resistant to many of the in-use antibiotics including carbapenems .

Conditions

Acute Myeloid Leukemia

Keywords

Carbapenem; enterobacterials,; Antibitic sensitivity; PCR

Outcome Measures

Primary Outcomes (1)

• Isolation of causative organism

  6 months

Secondary Outcomes (2)

• Antibitic sensitivity test:

  2 months

• Molecular detection of carbapenem resistant genes:

  3 months

Study Arms (2)

Group 1 Patients with enterobacterials infections

EXPERIMENTAL

Diagnostic Test: Antibiotic administration; Diagnostic Test: Molecular detection of antibiotic resistance

Group 2 patients with other bacterial infections

EXPERIMENTAL

Diagnostic Test: Antibiotic administration; Diagnostic Test: Molecular detection of antibiotic resistance

Interventions

Antibiotic administration DIAGNOSTIC_TEST

different samples were collected from patients admitted at oncology center at sohag

Group 1 Patients with enterobacterials infections; Group 2 patients with other bacterial infections

Molecular detection of antibiotic resistance DIAGNOSTIC_TEST

Molecular detection of carbapenem resistant genes: * Extraction of nucleic acid from isolated organisms by boiling. * Primers will be used for detection of carbaenem resistant genes

Group 1 Patients with enterobacterials infections; Group 2 patients with other bacterial infections

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to Sohag Oncology Center have different infections and isolated organism one of carbapenem resistant enterobacterales detected by antibiotic sensitivity test.

You may not qualify if:

• All patients admitted to Sohag Oncology Center having infections in different sites and isolated organisms are not one of enterobacterales and not carbapenem resistant.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university, Faculty of medicine

Sohag, 534568, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Noha Saber Shafik, Assistant professor

CONTACT

+201067261504; nohasaber@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: September 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: February 20, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)