Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study (SD-CRAB)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Sichuan
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Chengdu, Sichuan, China, 610072
- Recrutamento
- Sichuan Provincial People's Hospital
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Contato:
- Lingai Pan, MD
- Número de telefone: +86 17708130236
- E-mail: panlingai2004@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Hospitalized adult patients receiving anti-CRAB antimicrobial therapy in real-world clinical practice, including:
- patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection; or
- transplant recipients with donor-derived CRAB colonization or infection receiving early targeted therapy.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Sulbactam-Durlobactam Group
Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.
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Sulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.
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Non-Sulbactam-Durlobactam Group
Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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28-day All-Cause Mortality
Prazo: Up to 28 days after initiation of anti-CRAB therapy
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All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.
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Up to 28 days after initiation of anti-CRAB therapy
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical Failure
Prazo: Up to 28 days after initiation of anti-CRAB therapy
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Clinical failure defined as lack of clinical improvement, need for escalation of antimicrobial therapy, or death.
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Up to 28 days after initiation of anti-CRAB therapy
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Length of ICU stay
Prazo: Up to 90 days after ICU admission
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Duration of ICU stay measured from ICU admission to ICU discharge.
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Up to 90 days after ICU admission
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Time to clinical improvement
Prazo: Up to 28 days after initiation of anti-CRAB therapy
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Time from initiation of anti-CRAB therapy to predefined clinical improvement.
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Up to 28 days after initiation of anti-CRAB therapy
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Microbiological eradication
Prazo: Up to 14 days after initiation of anti-CRAB therapy
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Microbiological eradication confirmed by follow-up culture negativity.
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Up to 14 days after initiation of anti-CRAB therapy
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
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Outros números de identificação do estudo
- 2026-055
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