Acute Myeloid LeukemiaNCT07116356
Molecular Characterization of Carbapenemase-Producing Enterobacterales
A study testing Antibiotic administration and Molecular detection of antibiotic resistance in people with Acute Myeloid Leukemia, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Antibiotic administration and Molecular detection of antibiotic resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to Sohag Oncology Center have different infections and isolated organism one of carbapenem resistant enterobacterales detected by antibiotic sensitivity test.
Who cannot join
- All patients admitted to Sohag Oncology Center having infections in different sites and isolated organisms are not one of enterobacterales and not carbapenem resistant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university, Faculty of medicine
Sohag, 534568
sohag University, professor, +201063452930, Sohaguniversity@med.sohag.edu.eg
About this study
Official title: Molecular Characterization of Carbapenemase-Producing Enterobacterales Isolated From Clinical Samples in Egypt
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
- Being tested
- Antibiotic administration, Molecular detection of antibiotic resistance
- Keywords
- Carbapenem, enterobacterials,, Antibitic sensitivity, PCR
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic administrationDiagnostic test
different samples were collected from patients admitted at oncology center at sohag
Molecular detection of antibiotic resistanceDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Patients with enterobacterials infections | Experimental | Not described Receives: Diagnostic Test: Antibiotic administration; Diagnostic Test: Molecular detection of antibiotic resistance |
| Group 2 patients with other bacterial infections | Experimental | Not described Receives: Diagnostic Test: Antibiotic administration; Diagnostic Test: Molecular detection of antibiotic resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation of causative organism
Measured: 6 months
Secondary outcomes (2)
Antibitic sensitivity test:
Measured: 2 months
Molecular detection of carbapenem resistant genes:
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116356
- Sponsor's protocol ID
- Soh-Mmed-25-7-10PD
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Carbapenemase-Producing Enterobacterales Isolated From Clinical Samples in Egypt
- ClinicalTrials.gov ID
- NCT07116356
- Acronym / sponsor ID
- Soh-Mmed-25-7-10PD
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Carbapenem, enterobacterials,, Antibitic sensitivity, PCR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to Sohag Oncology Center have different infections and isolated organism one of carbapenem resistant enterobacterales detected by antibiotic sensitivity test.
Key exclusion criteria (1 listed)
- All patients admitted to Sohag Oncology Center having infections in different sites and isolated organisms are not one of enterobacterales and not carbapenem resistant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic administrationdifferent samples were collected from patients admitted at oncology center at sohag | Diagnostic test | Group 1 Patients with enterobacterials infections, Group 2 patients with other bacterial infections |
| Molecular detection of antibiotic resistanceMolecular detection of carbapenem resistant genes: * Extraction of nucleic acid from isolated organisms by boiling. * Primers will be used for detection of carbaenem resistant genes | Diagnostic test | Group 1 Patients with enterobacterials infections, Group 2 patients with other bacterial infections |
Primary outcome
Isolation of causative organism
Time frame: 6 months
2 secondary outcomes
Antibitic sensitivity test:
Time frame: 2 months
Molecular detection of carbapenem resistant genes:
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic administration and Molecular detection of antibiotic resistance in people with Acute Myeloid Leukemia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Saber Shafik, Assistant professor (+201067261504, nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation of causative organism (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.