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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary: 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.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: Microbiological clearance from blood [ Time Frame: Day 0,1,2,3,7 ]

Interval from positive to negative blood A. baumannii PCR and blood sterilization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival [ Time Frame: 14, 30, in-hospital stay ]
    Survival at 14, 30-day after enrollment. Survival to discharge.
  • Adverse drug reactions [ Time Frame: Day 0,1,2,3,7,14 ]
    Nephrotoxicity by RIFLE criteria
  • Subsequent infections and colonization [ Time Frame: During same admission or within 1 week of discharge ]


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: January 12, 2012
Date Started: August 2010
Date Completion: June 2013
Last Updated: January 17, 2012
Last Verified: January 2012