Ampicillin–sulbactam versus cefoperazone–sulbactam for multidrug-resistant Acinetobacter baumannii in critically ill patients

Comparison of the Clinical Efficacy of Ampicillin/Sulbactam and Cefoperazone/Sulbactam Against Multidrug Resistant Acinetobacter Baumannii Infections in Critically Ill Patients

This trial will test whether ampicillin–sulbactam or cefoperazone–sulbactam works better to treat carbapenem-resistant Acinetobacter baumannii infections in critically ill adults with sepsis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Cairo University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07118384 on ClinicalTrials.gov

What this trial studies

Critically ill adults (age ≥21) with signs of sepsis and a confirmed culture of carbapenem-resistant Acinetobacter baumannii will receive either intravenous ampicillin–sulbactam or cefoperazone–sulbactam. The study compares clinical outcomes such as infection resolution, mortality, and length of ICU stay between the two sulbactam-based regimens. Patients who have already received empirical sulbactam therapy or who have known hypersensitivity to the study drugs are excluded. The trial is conducted at Cairo University Hospitals Kasr Al-Ainy in Cairo, Egypt.

Who should consider this trial

Good fit: Adults aged 21 or older with sepsis and a confirmed culture of carbapenem-resistant Acinetobacter baumannii who have not received empirical sulbactam therapy and have no allergy to the study antibiotics.

Not a fit: Patients without carbapenem-resistant A. baumannii infection, those already on empirical sulbactam-containing therapy, or those with hypersensitivity to ampicillin-sulbactam or cefoperazone-sulbactam are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify which sulbactam-based regimen leads to better survival and faster recovery for patients with carbapenem-resistant A. baumannii in the ICU.

How similar studies have performed: Observational studies and small clinical reports have suggested benefit from sulbactam-containing regimens against A. baumannii, but direct head-to-head comparisons in critically ill CRAB patients remain limited.

Eligibility criteria

Inclusion Criteria:

* Inclusion criteria:

  1. Age ≥21 years old.
  2. Patient with signs and symptoms of sepsis.
  3. positive culture Carbapenem-resistant Acinetobacter baumannii (CRAB).

Exclusion Criteria:

* Exclusion criteria:

  1. Empirical sulbactam-based therapy against Gram-negative bacteria
  2. History of hypersensitivity reactions to ampicillin-sulbactam/cefoperazone-sulbactam

Where this trial is running

Cairo

• Cairo university hospitals kasr alainy — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Ayah M Khalil Ibrahem, MSc in clinical pharmacy

Conditions: Acinetobacter Baumannii Infection, Acinetobacter baumannii, cefoperazone- sulbactam, ampicillin-sulbactam