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Efficacy and safety of Colistin plus high dose ampicillin/sulbactam vs. colistin monotherapy for the treatment of carbapenem resistant Acinetobacter baumannii (CRAB) bacteremia: a multicenter, open-label, randomized controlled trial

Efficacy and safety of Colistin plus high dose ampicillin/sulbactam vs. colistin monotherapy for the treatment of carbapenem resistant Acinetobacter baumannii (CRAB) bacteremia: a multicenter, open-label, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008158
Enrollment
72
Registered
2023-02-03
Start date
2023-03-30
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients with CRAB bacteremia enrolled in this clinical trial will be randomly assigned to one of the two treatment groups below. • Group 1: Ampicillin/sulbactam 6g IV q6h + colistin (5mg/kg I

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who has signed a consent : If the patients is unable to provide the consent due to medical conditions, the patient's representative may provide the consent on behalf of the patient if permitted by local law and the standard work instructions. 2) An adult male or female aged 19 years or older as of the date of written consent 3) Patients who were confirmed Acinetobacter baumannii bacteremia by blood cultures using using peripheral blood or central venous blood before 96 hours of randomization.

Exclusion criteria

Exclusion criteria: 1) Patients with baceremia of other than Acinetobacter baumanii within 7 days 2) Patients who has been identified with bacteremia of multiple strains 3) Patients who has been treated for CRAB infection within 14 days 4) Paitents who has previously had a significant hypersensitivity to colistin or ampicillin/sulbactam 5) Patients who had received another clinical trial drug within 28 days 6) Patients who administred CRAB susceptible antibiotics including colistin for more than 72 hours immediately before taking the clinical trial drug, 7) Patients with pregnant or breast-feeding 8) Patients who are expected to die within 2 days after randomization by the investigator 9) Patients deemed unsuitable for participation in this clinical trial based on the medical opinion of the investigator

Design outcomes

Primary

MeasureTime frame
Clinical improvement

Secondary

MeasureTime frame
Clinical failure;All-cause mortality;Disease-specific mortality;Days to microbiological eradication;Days to resolution of fever;ICU length of stay;Days to discharge

Countries

Korea, Republic of

Contacts

Public ContactSeong Jin Choi

Seoul National University Bundang Hospital

seongjin2300@gmail.com+82-31-787-7847

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 23, 2026