Comparison of the Clinical Efficacy of Ampicillin/Sulbactam and Cefoperazone/Sulbactam Against Multidrug Resistant Acinetobacter Baumannii Infections in Critically Ill Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cefoperazone-sulbactam injection, Ampicillin - Sulbactam Injection.
- Who it may be relevant to
- Registry conditions: Acinetobacter Baumannii Infection. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Cefoperazone-sulbactam injection
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 - Drug Ampicillin - Sulbactam Injection
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.
Primary outcome measures
- Treatment effectiveness Based on Clinical improvement [Time frame: 5 days]
Secondary outcome measures (1)
- Bacteriological Response Assessed by Culture and Sensitivity Testing [Time frame: 5 days]
Eligibility criteria
Inclusion criteria
- Inclusion criteria:
- Age ≥21 years old.
- Patient with signs and symptoms of sepsis.
- positive culture Carbapenem-resistant Acinetobacter baumannii (CRAB).
Exclusion criteria
- Exclusion criteria:
- Empirical sulbactam-based therapy against Gram-negative bacteria
- History of hypersensitivity reactions to ampicillin-sulbactam/cefoperazone-sulbactam
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo university hospitals kasr alainy — Cairo
Identifiers
NCT: NCT07118384 · N-138-2025