Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study

NCT07601711 | Recruiting

• 1 other identifier: 2026-055
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter real-world observational cohort study designed to evaluate the effectiveness and safety of sulbactam-durlobactam in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections. Patients receiving sulbactam-durlobactam will be compared with those receiving other anti-CRAB regimens during the same period. The primary outcomes are 28-day all-cause mortality and clinical failure. Secondary outcomes include microbiological clearance, recurrence, length of hospital and ICU stay, duration of mechanical ventilation, and adverse events. To reduce confounding inherent in observational studies, propensity score methods, including matching and inverse probability weighting, will be applied. A nested therapeutic drug monitoring (TDM) sub-cohort will be established to explore the relationship between drug exposure and clinical outcomes.

Conditions

Carbapenem-Resistant Acinetobacter Baumannii Infection; Bloodstream Infection; Pneumonia; Sepsis

Keywords

CRAB Infection

Outcome Measures

Primary Outcomes (1)

• 28-day All-Cause Mortality

  All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.

  Up to 28 days after initiation of anti-CRAB therapy

Secondary Outcomes (4)

• Clinical Failure

  Up to 28 days after initiation of anti-CRAB therapy

• Length of ICU stay

  Up to 90 days after ICU admission

• Time to clinical improvement

  Up to 28 days after initiation of anti-CRAB therapy

• Microbiological eradication

  Up to 14 days after initiation of anti-CRAB therapy

Study Arms (2)

Sulbactam-Durlobactam Group

Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.

Drug: Sulbactam-Durlobactam

Non-Sulbactam-Durlobactam Group

Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam.

Interventions

Sulbactam-Durlobactam DRUG

Sulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.

Sulbactam-Durlobactam Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients receiving anti-CRAB antimicrobial therapy in real-world clinical practice, including: 1. patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection; or 2. transplant recipients with donor-derived CRAB colonization or infection receiving early targeted therapy.

You may qualify if:

• Age ≥18 years.
• Hospitalized patients receiving anti-CRAB antimicrobial therapy, including:
• patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection based on microbiological testing in combination with clinical evidence of infection; or
• transplant recipients with donor-derived CRAB colonization or infection who receive early targeted antimicrobial therapy.
• Treatment initiation time can be clearly determined.
• Availability of clinical outcome data.

You may not qualify if:

• Colonization without evidence of active infection.
• Missing key clinical data.
• Inability to determine treatment initiation time.
• Pregnancy or lactation.
• Patients considered unsuitable by investigators.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (3)

• Kaye KS, Shorr AF, Wunderink RG, Du B, Poirier GE, Rana K, Miller A, Lewis D, O'Donnell J, Chen L, Reinhart H, Srinivasan S, Isaacs R, Altarac D. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. 2023 Sep;23(9):1072-1084. doi: 10.1016/S1473-3099(23)00184-6. Epub 2023 May 11.

  PMID: 37182534 BACKGROUND

• Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N; WHO Pathogens Priority List Working Group. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 Mar;18(3):318-327. doi: 10.1016/S1473-3099(17)30753-3. Epub 2017 Dec 21.

  PMID: 29276051 BACKGROUND

• Covvey JR, Guarascio AJ. Sulbactam-durlobactam for the treatment of Acinetobacter baumannii-calcoaceticus complex. Expert Rev Anti Infect Ther. 2024 Nov;22(11):925-934. doi: 10.1080/14787210.2024.2400703. Epub 2024 Sep 8.

  PMID: 39234753 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be collected for therapeutic drug monitoring (TDM) of sulbactam-durlobactam. Blood samples will be obtained at predefined time points within a dosing interval, and plasma will be separated and stored for measurement of drug concentrations using validated LC-MS/MS methods.

MeSH Terms

Conditions

Sepsis; Pneumonia

Interventions

sulbactam-durlobactam

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Critical Care Medicine

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: May 22, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): November 11, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)