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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01511224
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012

January 12, 2012
January 17, 2012
August 2010
December 2012   (final data collection date for primary outcome measure)
Microbiological clearance from blood [ Time Frame: Day 0,1,2,3,7 ] [ Designated as safety issue: No ]
Interval from positive to negative blood A. baumannii PCR and blood sterilization.
Same as current
Complete list of historical versions of study NCT01511224 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: 14, 30, in-hospital stay ] [ Designated as safety issue: No ]
    Survival at 14, 30-day after enrollment. Survival to discharge.
  • Adverse drug reactions [ Time Frame: Day 0,1,2,3,7,14 ] [ Designated as safety issue: Yes ]
    Nephrotoxicity by RIFLE criteria
  • Subsequent infections and colonization [ Time Frame: During same admission or within 1 week of discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.

Acinetobacter Bacteraemia
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Aristine Cheng, MBBChir +886 975765607 aristine@hotmail.com
Contact: Hsin-Yun Sun, MD +886 972651122 hysun13@gmail.com
Taiwan
 
NCT01511224
NTUH-TD-B-111-001
No
National Taiwan University Hospital
National Taiwan University Hospital
Far Eastern Memorial Hospital
Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital
National Taiwan University Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP