Carbapenem-Resistant Acinetobacter Baumannii InfectionSD-CRABNCT07601711
Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study
An observational study of Carbapenem-Resistant Acinetobacter Baumannii Infection and Bloodstream Infection, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection, Pneumonia
- What is being tested?
- Sulbactam-Durlobactam
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 11 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Colonization without evidence of active infection.
- Missing key clinical data.
- Inability to determine treatment initiation time.
- Pregnancy or lactation.
- Patients considered unsuitable by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Lingai Pan, MD, +86 17708130236, panlingai2004@163.com
About this study
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
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.
Read the 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).
- Conditions
- Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection, Pneumonia, Sepsis
- Being tested
- Sulbactam-Durlobactam
- Keywords
- CRAB Infection
- Medical subject headings
- Sepsis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulbactam-DurlobactamDrug
Sulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.
| Study group | Role | What they receive |
|---|---|---|
| Sulbactam-Durlobactam Group | Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation. Receives: Drug: Sulbactam-Durlobactam | |
| Non-Sulbactam-Durlobactam Group | Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day All-Cause Mortality
All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.
Measured: Up to 28 days after initiation of anti-CRAB therapy
Secondary outcomes (4)
Clinical Failure
Clinical failure defined as lack of clinical improvement, need for escalation of antimicrobial therapy, or death.
Measured: Up to 28 days after initiation of anti-CRAB therapy
Length of ICU stay
Duration of ICU stay measured from ICU admission to ICU discharge.
Measured: Up to 90 days after ICU admission
Time to clinical improvement
Time from initiation of anti-CRAB therapy to predefined clinical improvement.
Measured: Up to 28 days after initiation of anti-CRAB therapy
Microbiological eradication
Microbiological eradication confirmed by follow-up culture negativity.
Measured: Up to 14 days after initiation of anti-CRAB therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start11 Nov 2025
- Primary completion11 Nov 2027 (estimated)
- Study completion11 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carbapenem-Resistant Acinetobacter Baumannii InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601711
- Sponsor's protocol ID
- 2026-055
- Acronym
- SD-CRAB
- Status last verified
- May 2026
- First submitted
- 29 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient privacy protection.
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 trial (ATTACK). Lancet Infect Dis. 2023 Sep;23(9):1072-1084. doi: 10.1016/S1473-3099(23)00184-6. Epub 2023 May 11.
PubMed 37182534Tacconelli 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.
PubMed 29276051Covvey 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.
PubMed 39234753
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601711
- Acronym / sponsor ID
- SD-CRAB / 2026-055
- Conditions
- Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection, Pneumonia, Sepsis
- Keywords
- CRAB Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulbactam-Durlobactam Group | – | Drug: Sulbactam-DurlobactamPatients receiving sulbactam-durlobactam within 48 hours after treatment initiation. |
| Non-Sulbactam-Durlobactam Group | – | –Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Hospitalized patients receiving anti-CRAB antimicrobial therapy, including:
- Treatment initiation time can be clearly determined.
- Availability of clinical outcome data.
Key exclusion criteria (5 listed)
- Colonization without evidence of active infection.
- Missing key clinical data.
- Inability to determine treatment initiation time.
- Pregnancy or lactation.
- Patients considered unsuitable by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulbactam-DurlobactamSulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection. | Drug | Sulbactam-Durlobactam Group |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 37182534Kaye 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.
- Background: PubMed 29276051Tacconelli 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.
- Background: PubMed 39234753Covvey 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient privacy protection.
Related trials for Carbapenem-Resistant Acinetobacter Baumannii Infection
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Not yet recruitingPhase 2
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
RecruitingPhase 4
Therapeutic Options for CRAB
Infections, Bacterial, Sepsis Bacterial
Active, not recruitingObservational study
Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation
Carbapenem Resistant Bacterial Infection, Acinetobacter Baumannii Infection
RecruitingPhase 4
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem-Resistant Acinetobacter Baumannii Infection and Bloodstream Infection, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day All-Cause Mortality (time frame: Up to 28 days after initiation of anti-CRAB therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07601711, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.