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
  Purpose

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.


Condition
Acinetobacter Bacteraemia

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
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

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511224

Contacts
Contact: Aristine Cheng, MBBChir +886 975765607 aristine@hotmail.com
Contact: Hsin-Yun Sun, MD +886 972651122 hysun13@gmail.com

Locations
Taiwan
Yunlinn NTUH Branch Recruiting
Douliou, Taiwan
Contact: Chia-Ling Yang, MD       y01944@ms1.ylh.gov.tw   
Far Eastern Memorial Hospital Recruiting
New Taipei, Taiwan, 220
Contact: Aristine Cheng, MD       aristine@hotmail.com   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Hsin-Yun Sun, MD    +886 97265112    hysun13@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01511224     History of Changes
Other Study ID Numbers: NTUH-TD-B-111-001
Study First Received: January 12, 2012
Last Updated: January 17, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Bloodstream infections
Acinetobacter
Drug resistant Acinetobacter baumannii bacteremia

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014