Clinical trial NCT01511224: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acinetobacter Bacteraemia
Keywords: Bloodstream infections
Acinetobacter
Drug resistant Acinetobacter baumannii bacteremia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2012-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Microbiological clearance from blood
timeFrame: Day 0,1,2,3,7
Secondary outcomes:
measure: Survival
timeFrame: 14, 30, in-hospital stay
measure: Adverse drug reactions
timeFrame: Day 0,1,2,3,7,14
measure: Subsequent infections and colonization
timeFrame: During same admission or within 1 week of discharge
Other outcomes:
Locations:
city: Douliou
country: Taiwan
facility: Yunlinn NTUH Branch
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsin-Yun Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: