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

19. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610072
        • Rekruttering
        • Sichuan Provincial People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Sulbactam-Durlobactam Group
Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
28-day All-Cause Mortality
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Failure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sichuan Provincial People's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. november 2025

Primær fullføring (Antatt)

11. november 2027

Studiet fullført (Antatt)

11. november 2027

Datoer for studieregistrering

Først innsendt

29. mars 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-055

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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