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Recruiting NCT07601711

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

— Observational Carbapenem-Resistant Acinetobacter Baumannii Infection Bloodstream Infection Pneumonia Sepsis

For patients and families

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: Sulbactam-Durlobactam.
Who it may be relevant to
Registry conditions: Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection, Pneumonia, Sepsis. Basic parameters: from 18 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

This is a Single-center Real-world Observational Cohort Study of Sulbactam-Durlobactam for Carbapenem-Resistant Acinetobacter Baumannii Infections: Effectiveness, Safety, and Exposure-Response Analysis

Overview

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.

Detailed description

This is a single-center real-world observational cohort study including hospitalized adult patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections. Patients will be classified into two groups based on treatment exposure: those receiving sulbactam-durlobactam and those receiving alternative anti-CRAB regimens during the same period.

The study aims to evaluate the effectiveness and safety of sulbactam-durlobactam in high-risk populations, including transplant recipients and critically ill patients. The primary outcomes are 28-day all-cause mortality and clinical failure. Secondary outcomes include microbiological clearance, recurrence, ICU length of stay, duration of mechanical ventilation, and treatment-related adverse events.

To minimize bias inherent in observational studies, propensity score matching, inverse probability of treatment weighting (IPTW), and multivariable regression models will be applied to adjust for baseline differences between groups. Landmark analysis will be conducted to address time-related biases.

A nested therapeutic drug monitoring (TDM) sub-cohort will be included. Plasma samples will be collected at predefined time points within a dosing interval, and drug concentrations will be measured using validated LC-MS/MS methods. Population pharmacokinetic modeling will be performed to estimate exposure parameters, including Cmin, Cmax, and AUC. The relationship between drug exposure and clinical outcomes, as well as PK/PD target attainment, will be further explored.

Subgroup analyses will be conducted according to infection status (confirmed infection vs. donor-derived colonization or infection).

Interventions

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

Primary outcome measures

  • 28-day All-Cause Mortality [Time frame: Up to 28 days after initiation of anti-CRAB therapy]
Secondary outcome measures (4)
  • Clinical Failure [Time frame: Up to 28 days after initiation of anti-CRAB therapy]
  • Length of ICU stay [Time frame: Up to 90 days after ICU admission]
  • Time to clinical improvement [Time frame: Up to 28 days after initiation of anti-CRAB therapy]
  • Microbiological eradication [Time frame: Up to 14 days after initiation of anti-CRAB therapy]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Sichuan Provincial People's Hospital — Chengdu

Publications

  • 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 tr PMID 37182534
  • 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 bacter PMID 29276051
  • 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

Identifiers

NCT: NCT07601711 · 2026-055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗