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A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia

A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01511224
Acronym
ANTI-AB
Enrollment
200
Registered
2012-01-18
Start date
2010-08-31
Completion date
2013-06-30
Last updated
2012-01-18

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

Conditions

Acinetobacter Bacteraemia

Keywords

Bloodstream infections, Acinetobacter, Drug resistant Acinetobacter baumannii bacteremia

Brief summary

Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in hospitals locally and worldwide. There is lack of prospective comparative clinical data to guide optimal strategy for treating such infections. Since it remains unclear how to treat bacteremia caused by AB, the present study aims to enroll patients at multiple sites with extensively drug resistant Acinetobacter species bacteremia receiving different combination therapy to assess treatment outcomes and analyze risk factors associated with mortality.

Detailed description

Patients with AB bacteremia receiving antimicrobial therapy are eligible for this multicenter study. Antimicrobial agents are decided at the discretion of the attending clinical team. Clinical data to be collected include patient demographics (age, gender, underlying diseases, Pitt Bacteremia Score \[20\], duration of ICU stay and hospitalization before the day of first positive blood culture, central venous catheterization), antimicrobial agents on the day of bacteremia, regimens and durations of combination therapy after enrollment, and outcomes (sequential quantification change of blood A. baumannii polymerase chain reaction \[PCR\], survival at day 30 after enrollment, and adverse drug reactions of antimicrobial agents). Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR quantification of A. baumannii and for genospecies identification. Primary end points are the interval from study enrollment to negative blood A. baumannii PCR and blood sterilization. Secondary end points are survival at 14 and 30-day after enrollment, adverse drug reactions of antimicrobial agents, and risk factors for survival at 30-day after enrollment. Inclusion criteria: 1. Adults \>16 years 2. With blood culture isolate(s) A. baumannii. 3. Informed consent gained. Exclusion criteria: 1. Second/repeat episodes of bacteremia 2. Patients who could not or did not receive antimicrobial treatment 3. Patient not admitted to hospital.

Interventions

None listed

Sponsors

Far Eastern Memorial Hospital
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults ( \>16 years) * With blood culture isolate(s) A. baumannii * Informed consent gained

Exclusion criteria

* Second/repeat episodes of bacteremia * Patients who could not or did not receive antimicrobial treatment * Patient not admitted to hospital

Design outcomes

Primary

MeasureTime frameDescription
Microbiological clearance from bloodDay 0,1,2,3,7Interval from positive to negative blood A. baumannii PCR and blood sterilization.

Secondary

MeasureTime frameDescription
Survival14, 30, in-hospital staySurvival at 14, 30-day after enrollment. Survival to discharge.
Adverse drug reactionsDay 0,1,2,3,7,14Nephrotoxicity by RIFLE criteria
Subsequent infections and colonizationDuring same admission or within 1 week of discharge

Countries

Taiwan

Contacts

Primary ContactAristine Cheng, MBBChir
aristine@hotmail.com+886 975765607
Backup ContactHsin-Yun Sun, MD
hysun13@gmail.com+886 972651122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026