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

May 19, 2026 updated by: Lingai Pan, Sichuan Provincial People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Age ≥18 years.

  • Hospitalized patients receiving anti-CRAB antimicrobial therapy, including:

    1. patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection based on microbiological testing in combination with clinical evidence of infection; or
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sulbactam-Durlobactam Group
Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.
Drug: Sulbactam-Durlobactam
Sulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.
Non-Sulbactam-Durlobactam Group
Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day All-Cause Mortality
Time Frame: Up to 28 days after initiation of anti-CRAB therapy
All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.
Up to 28 days after initiation of anti-CRAB therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Failure
Time Frame: Up to 28 days after initiation of anti-CRAB therapy
Clinical failure defined as lack of clinical improvement, need for escalation of antimicrobial therapy, or death.
Up to 28 days after initiation of anti-CRAB therapy
Length of ICU stay
Time Frame: Up to 90 days after ICU admission
Duration of ICU stay measured from ICU admission to ICU discharge.
Up to 90 days after ICU admission
Time to clinical improvement
Time Frame: Up to 28 days after initiation of anti-CRAB therapy
Time from initiation of anti-CRAB therapy to predefined clinical improvement.
Up to 28 days after initiation of anti-CRAB therapy
Microbiological eradication
Time Frame: Up to 14 days after initiation of anti-CRAB therapy
Microbiological eradication confirmed by follow-up culture negativity.
Up to 14 days after initiation of anti-CRAB therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

November 11, 2027

Study Completion (Estimated)

November 11, 2027

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies and patient privacy protection.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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