Acinetobacter Baumannii InfectionNCT07118384
Comparison of the Clinical Efficacy of Ampicillin/Sulbactam and Cefoperazone/Sulbactam Against Multidrug Resistant Acinetobacter Baumannii Infections in Critically Ill Patients
A study testing Cefoperazone-sulbactam injection and Ampicillin - Sulbactam Injection in people with Acinetobacter Baumannii Infection, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the clinical effectiveness of two different sulbactam-based regimens (ampicillin-sulbactam versus cefoperazone-sulbactam) in the treatment of Acinetobacter baumannii infections in critically ill patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acinetobacter Baumannii Infection
- What is being tested?
- Cefoperazone-sulbactam injection and Ampicillin - Sulbactam Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to Jan 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years old.
- Patient with signs and symptoms of sepsis.
- positive culture Carbapenem-resistant Acinetobacter baumannii (CRAB).
Who cannot join
- Empirical sulbactam-based therapy against Gram-negative bacteria
- History of hypersensitivity reactions to ampicillin-sulbactam/cefoperazone-sulbactam
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, 1 recruiting
- Recruiting
Cairo university hospitals kasr alainy
Cairo, 11562
About this study
To compare the clinical effectiveness of two different sulbactam-based regimens (ampicillin-sulbactam versus cefoperazone-sulbactam) in the treatment of Acinetobacter baumannii infections in critically ill patients.
Read the detailed description
Among Acinetobacter species, Acinetobacter baumannii is the most important member and is commonly implicated in nosocomial infections. Acinetobacter baumannii is a gram-negative coccobacillus that has emerged from an organism of questionable pathogenicity to an infectious agent of importance to hospitals worldwide. In the intensive care unit ICU setting, Acinetobacter baumannii has been implicated in severe and occasionally life-threatening infections such as ventilator-associated pneumonia and bloodstream infections. Acinetobacter baumannii can produce biofilms in environments exposed to antibiotics; thus, it can survive for long periods and easily develop multidrug (MD), extremely or extensively drug (XD), and even pan-drug resistances (R) to various types of antibiotics, resulting in high patient mortality.
The underlying mechanisms can be divided into three categories. First, A. baumannii produces decomposition enzymes that deactivate antibiotics. Second, it can reduce or hinder the entry of antibiotics. For example, A. baumannii prevents the entry of antibiotics by controlling efflux pumps, or it can remove the antibiotics that have entered the cells. Third, point mutations alter the targets or functions of bacteria and reduce their affinity for antibiotics. Owing to its strong infectivity and drug resistance, A. baumannii has been added to the list of the World Health Organization's antibiotic-resistance priority pathogens.
Sulbactam, a beta-lactamase inhibitor, is commercially available mainly in combination with β-lactam antibiotics (as in ampicillin-sulbactam or cefoperazone-sulbactam), is a drug containing a beta-lactam ring derived from 6-aminopenicllanic acid. It can bind to the active sites of b-lactamase antibiotics to protect against antibiotic hydrolysis and restore antibiotic activity.
The antimicrobial property distinguishing sulbactam from other beta-lactamase inhibitors is its activity against Acinetobacter spp. Therefore, sulbactam is an alternative treatment option due to the worldwide spread of multidrug resistance Acinetobacter baumannii, for which only a few effective antimicrobial agents are currently available. The Infectious Diseases Society of America Antimicrobial-Resistant Treatment Guidance suggests that high-dose ampicillin-sulbactam (total daily dose of 6-9 grams of the sulbactam component) be included in the combination therapy regimen. If ampicillin-sulbactam non-susceptibility is shown, high-dose ampicillin-sulbactam can still be a helpful therapy choice. Acinetobacter baumannii isolates in China were more susceptible to cefoperazone-sulbactam than to ampicillin-sulbactam (resistance rates 48.8% vs 59.1%). The literature's limited data indicated that patients with Acinetobacter baumannii may expect moderate clinical benefits with Cefoperazone -Sulbactam. Salvation therapy may be attempted with combination treatment, particularly with polymyxins. There are no randomized controlled studies investigating the effectiveness of cefoperazone-sulbactam in the presence or absence of polymyxins for Acinetobacter baumannii infections.
- Conditions
- Acinetobacter Baumannii Infection
- Being tested
- Cefoperazone-sulbactam injection, Ampicillin - Sulbactam Injection
- Keywords
- Acinetobacter baumannii, cefoperazone- sulbactam, ampicillin-sulbactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefoperazone-sulbactam injectionDrug
Two grams of Cefoperazone/sulbactam IV are administered every 8 hours, and each dose is administered as an extended infusion over 4 hours. The solution is diluted with a compatible solution (normal saline 0.9%) with a maximum final concentration of 250 mg/ml
Ampicillin - Sulbactam InjectionDrug
Two grams of Ampicillin/sulbactam IV are administered every 8 hours, and each dose is administered as an extended infusion over 4 hours. The solution is diluted with a compatible solution (normal saline 0.9%) with a final concentration not exceeding 45mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| Ampicillin- sulbactam | Active comparator | Intravenous ampicillin-sulbactam (2:1) Receives: Drug: Ampicillin - Sulbactam Injection |
| Cefoperazone-sulbactam | Experimental | intravenous cefoperazone-sulbactam (1:1) Receives: Drug: Cefoperazone-sulbactam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effectiveness Based on Clinical improvement
Clinical response will be assessed by ICU physicians based on physical examination findings and daily clinical records on Day 5 of treatment.
Patients will be classified into one of the following categories:
- Cure: Complete resolution of signs and symptoms related to the infection
- Failure: No improvement, persistence of symptoms beyond 72 hours, or deterioration requiring antibiotic escalation Unit of Measure: % of patients with clinical cure or failure Clinical evaluation performed daily by ICU physicians using physical examination and patient records, in accordance with standardized definitions of clinical response outlined by the CDC (Centers for Disease Control and Prevention) and IDSA (Infectious Diseases Society of America) 2024-2025 guidelines including primary blood stream infection-skin and soft tissue and surgical site infection-intra abdominal infection- lower respiratory infection- urinary tract infection- catheter related infection and bone and joint infection.
Measured: 5 days
Secondary outcomes (1)
Bacteriological Response Assessed by Culture and Sensitivity Testing
Microbiological eradication will be assessed using microbiological cultures collected on Day 5 from appropriate clinical specimens (e.g., sputum, blood, wound, urine, central line ).
Categories of response include:
- Eradication: No growth of Acinetobacter baumannii
- Persistence: Continued growth of A. baumannii
- Superinfection: Growth of a new microorganism Unit of Measure: % of patients with eradication, persistence, or superinfection Antimicrobial susceptibility of the isolated bacteria was determined by the Kirby-Bauer disc diffusion method based on the Clinical and Laboratory Standard Institute (CLSI) guideline. The isolates resistant to 2 or more drug classes simultaneously were considered to be multidrug resistant (MDR) (hospital microbiology laboratory).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 May 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter Baumannii InfectionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-labeled, Parallel, Randomized, Controlled study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayah Mohammed Khalil Ibrahem, Cairo University
- Investigators
- Ahmed M Mukhtar, Professor Anesthesia and ICU, Study director, Cairo Univesrsity hospitals Kasr Alainy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118384
- Sponsor's protocol ID
- N-138-2025
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of Ampicillin/Sulbactam and Cefoperazone/Sulbactam Against Multidrug Resistant Acinetobacter Baumannii Infections in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07118384
- Acronym / sponsor ID
- N-138-2025
- Conditions
- Acinetobacter Baumannii Infection
- Keywords
- Acinetobacter baumannii, cefoperazone- sulbactam, ampicillin-sulbactam
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 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.
To compare the clinical effectiveness of two different sulbactam-based regimens (ampicillin-sulbactam versus cefoperazone-sulbactam) in the treatment of Acinetobacter baumannii infections in critically ill patients.
Detailed description
Among Acinetobacter species, Acinetobacter baumannii is the most important member and is commonly implicated in nosocomial infections. Acinetobacter baumannii is a gram-negative coccobacillus that has emerged from an organism of questionable pathogenicity to an infectious agent of importance to hospitals worldwide. In the intensive care unit ICU setting, Acinetobacter baumannii has been implicated in severe and occasionally life-threatening infections such as ventilator-associated pneumonia and bloodstream infections. Acinetobacter baumannii can produce biofilms in environments exposed to antibiotics; thus, it can survive for long periods and easily develop multidrug (MD), extremely or extensively drug (XD), and even pan-drug resistances (R) to various types of antibiotics, resulting in high patient mortality.
The underlying mechanisms can be divided into three categories. First, A. baumannii produces decomposition enzymes that deactivate antibiotics. Second, it can reduce or hinder the entry of antibiotics. For example, A. baumannii prevents the entry of antibiotics by controlling efflux pumps, or it can remove the antibiotics that have entered the cells. Third, point mutations alter the targets or functions of bacteria and reduce their affinity for antibiotics. Owing to its strong infectivity and drug resistance, A. baumannii has been added to the list of the World Health Organization's antibiotic-resistance priority pathogens.
Sulbactam, a beta-lactamase inhibitor, is commercially available mainly in combination with β-lactam antibiotics (as in ampicillin-sulbactam or cefoperazone-sulbactam), is a drug containing a beta-lactam ring derived from 6-aminopenicllanic acid. It can bind to the active sites of b-lactamase antibiotics to protect against antibiotic hydrolysis and restore antibiotic activity.
The antimicrobial property distinguishing sulbactam from other beta-lactamase inhibitors is its activity against Acinetobacter spp. Therefore, sulbactam is an alternative treatment option due to the worldwide spread of multidrug resistance Acinetobacter baumannii, for which only a few effective antimicrobial agents are currently available. The Infectious Diseases Society of America Antimicrobial-Resistant Treatment Guidance suggests that high-dose ampicillin-sulbactam (total daily dose of 6-9 grams of the sulbactam component) be included in the combination therapy regimen. If ampicillin-sulbactam non-susceptibility is shown, high-dose ampicillin-sulbactam can still be a helpful therapy choice. Acinetobacter baumannii isolates in China were more susceptible to cefoperazone-sulbactam than to ampicillin-sulbactam (resistance rates 48.8% vs 59.1%). The literature's limited data indicated that patients with Acinetobacter baumannii may expect moderate clinical benefits with Cefoperazone -Sulbactam. Salvation therapy may be attempted with combination treatment, particularly with polymyxins. There are no randomized controlled studies investigating the effectiveness of cefoperazone-sulbactam in the presence or absence of polymyxins for Acinetobacter baumannii infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-labeled, Parallel, Randomized, Controlled study.
| Arm | Type | Receives |
|---|---|---|
| Ampicillin- sulbactam | Active comparator | Drug: Ampicillin - Sulbactam InjectionIntravenous ampicillin-sulbactam (2:1) |
| Cefoperazone-sulbactam | Experimental | Drug: Cefoperazone-sulbactam injectionintravenous cefoperazone-sulbactam (1:1) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Cefoperazone-sulbactam injectionTwo grams of Cefoperazone/sulbactam IV are administered every 8 hours, and each dose is administered as an extended infusion over 4 hours. The solution is diluted with a compatible solution (normal saline 0.9%) with a maximum final concentration of 250 mg/ml | Drug | Cefoperazone-sulbactam |
| Ampicillin - Sulbactam InjectionTwo grams of Ampicillin/sulbactam IV are administered every 8 hours, and each dose is administered as an extended infusion over 4 hours. The solution is diluted with a compatible solution (normal saline 0.9%) with a final concentration not exceeding 45mg/ml. | Drug | Ampicillin- sulbactam |
Primary outcome
Treatment effectiveness Based on Clinical improvement
Time frame: 5 days
Clinical response will be assessed by ICU physicians based on physical examination findings and daily clinical records on Day 5 of treatment. Patients will be classified into one of the following categories: * Cure: Complete resolution of signs and symptoms related to the infection * Failure: No improvement, persistence of symptoms beyond 72 hours, or deterioration requiring antibiotic escalation Unit of Measure: % of patients with clinical cure or failure Clinical evaluation performed daily by ICU physicians using physical examination and patient records, in accordance with standardized definitions of clinical response outlined by the CDC (Centers for Disease Control and Prevention) and IDSA (Infectious Diseases Society of America) 2024-2025 guidelines including primary blood stream infection-skin and soft tissue and surgical site infection-intra abdominal infection- lower respiratory infection- urinary tract infection- catheter related infection and bone and joint infection.
1 secondary outcome
Bacteriological Response Assessed by Culture and Sensitivity Testing
Time frame: 5 days
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 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acinetobacter Baumannii Infection
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
RecruitingPhase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
RecruitingObservational study
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
RecruitingObservational study
Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study
Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection
Not yet recruitingPhase 2
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
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.
Ahmed M Mukhtar, Professor Anesthesia and ICU study director
Cairo Univesrsity hospitals Kasr Alainy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefoperazone-sulbactam injection and Ampicillin - Sulbactam Injection in people with Acinetobacter Baumannii Infection, run by Cairo 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 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 Ayah M Khalil Ibrahem, MSc in clinical pharmacy (+20 1094748214, dr.ayaaa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness Based on Clinical improvement (time frame: 5 days). 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 12 Aug 2025.