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

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.

Study Overview

• Status: Unknown
• Conditions: Acinetobacter Bacteraemia

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
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Aristine Cheng, MBBChir; Phone Number: +886 975765607; Email: aristine@hotmail.com
• Study Contact Backup: Name: Hsin-Yun Sun, MD; Phone Number: +886 972651122; Email: hysun13@gmail.com

Study Locations

• Taiwan
  • Douliou, Taiwan
    • Recruiting
    • Yunlinn NTUH Branch
    • Contact: Chia-Ling Yang, MD; Email: y01944@ms1.ylh.gov.tw
  • New Taipei, Taiwan, 220
    • Recruiting
    • Far Eastern Memorial Hospital
    • Contact: Aristine Cheng, MD; Email: aristine@hotmail.com
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Hsin-Yun Sun, MD; Phone Number: +886 97265112; Email: hysun13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological clearance from blood	Interval from positive to negative blood A. baumannii PCR and blood sterilization.	Day 0,1,2,3,7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Hsin-Yun Sun, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 17, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Bloodstream infections; Acinetobacter; Drug resistant Acinetobacter baumannii bacteremia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: NTUH-TD-B-111-001