A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia (ANTI-AB)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy|
- 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.
- 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 ]
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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|
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 , 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511224
|Contact: Aristine Cheng, MBBChir||+886 firstname.lastname@example.org|
|Contact: Hsin-Yun Sun, MD||+886 email@example.com|
|Yunlinn NTUH Branch||Recruiting|
|Contact: Chia-Ling Yang, MD firstname.lastname@example.org|
|Far Eastern Memorial Hospital||Recruiting|
|New Taipei, Taiwan, 220|
|Contact: Aristine Cheng, MD email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Hsin-Yun Sun, MD +886 97265112 firstname.lastname@example.org|
|Principal Investigator:||Hsin-Yun Sun, MD||National Taiwan University Hospital|