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

NCT07118384 | Recruiting

• 1 other identifier: N-138-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acinetobacter Baumannii Infection

Keywords

Acinetobacter baumannii; cefoperazone- sulbactam; ampicillin-sulbactam

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (1)

• Bacteriological Response Assessed by Culture and Sensitivity Testing

  5 days

Study Arms (2)

Ampicillin- sulbactam

ACTIVE COMPARATOR

Intravenous ampicillin-sulbactam (2:1)

Drug: Ampicillin - Sulbactam Injection

Cefoperazone-sulbactam

EXPERIMENTAL

intravenous cefoperazone-sulbactam (1:1)

Drug: Cefoperazone-sulbactam injection

Interventions

Cefoperazone-sulbactam injection DRUG

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

Cefoperazone-sulbactam

Ampicillin - Sulbactam Injection DRUG

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.

Ampicillin- sulbactam

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals kasr alainy

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

sultamicillin

Study Officials

• Ahmed M Mukhtar, Professor Anesthesia and ICU

  Cairo Univesrsity hospitals Kasr Alainy

  STUDY DIRECTOR

Central Study Contacts

Ayah M Khalil Ibrahem, MSc in clinical pharmacy

CONTACT

+20 1094748214; dr.ayaaa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical pharmacist -Trauma and surgical ICU ER185 at Kasr alainy hospital, MSc , BCPS

Model Details: Open-labeled, Parallel, Randomized, Controlled study.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 12, 2025
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

EG (1)