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A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia (ANTI-AB)

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ClinicalTrials.gov Identifier: NCT01511224
Recruitment Status : Unknown
Verified January 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date January 12, 2012
First Posted Date January 18, 2012
Last Update Posted Date January 18, 2012
Study Start Date August 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2012)
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 Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 17, 2012)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia
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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR identification and quantification of Acinetobacter species.
Sampling Method Non-Probability Sample
Study Population Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.
Condition Acinetobacter Bacteraemia
Intervention Not Provided
Study Groups/Cohorts
  • Colistin monotherapy
  • Colistin based combination therapy
    Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn
  • Non-colistin containing regime
  • Glycopeptide with colistin combination
  • Colistin with loading dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 17, 2012)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01511224
Other Study ID Numbers NTUH-TD-B-111-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Far Eastern Memorial Hospital
Investigators
Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date January 2012