Molecular Characterization of Carbapenemase-Producing Enterobacterales

NCT ID: NCT07116356

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2026-02-20

Brief Summary

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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 .

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1 Patients with enterobacterials infections

Group Type EXPERIMENTAL

Antibiotic administration

Intervention Type DIAGNOSTIC_TEST

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

Molecular detection of antibiotic resistance

Intervention Type 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 2 patients with other bacterial infections

Group Type EXPERIMENTAL

Antibiotic administration

Intervention Type DIAGNOSTIC_TEST

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

Molecular detection of antibiotic resistance

Intervention Type 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

Interventions

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Antibiotic administration

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

Intervention Type DIAGNOSTIC_TEST

Molecular detection of antibiotic resistance

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

4 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Noha Saber Shafik

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university, Faculty of medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Noha Saber Shafik, Assistant professor

Role: CONTACT

+201067261504

Facility Contacts

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sohag University, professor

Role: primary

+201063452930

Related Links

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Other Identifiers

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Soh-Mmed-25-7-10PD

Identifier Type: -

Identifier Source: org_study_id

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