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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

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.

Disqualifiers

Colonization without evidence of active infection.

Missing key clinical data.

Inability to determine treatment initiation time.

Pregnancy or lactation.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Sulbactam-Durlobactam

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Sulbactam-Durlobactam Group1 intervention
Group B: Non-Sulbactam-Durlobactam Group0 interventions

Trial outcomes

Primary outcomes

1

28-day All-Cause Mortality

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

Time frame
Up to 28 days after initiation of anti-CRAB therapy

Secondary outcomes

1

Clinical Failure

Clinical failure defined as lack of clinical improvement, need for escalation of antimicrobial therapy, or death.

Time frame
Up to 28 days after initiation of anti-CRAB therapy
2

Length of ICU stay

Duration of ICU stay measured from ICU admission to ICU discharge.

Time frame
Up to 90 days after ICU admission
3

Time to clinical improvement

Time from initiation of anti-CRAB therapy to predefined clinical improvement.

Time frame
Up to 28 days after initiation of anti-CRAB therapy
4

Microbiological eradication

Microbiological eradication confirmed by follow-up culture negativity.

Time frame
Up to 14 days after initiation of anti-CRAB therapy

Other outcomes

Sponsors and contacts

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