A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia

Acinetobacter Bacteraemia Clinical Trial

— ANTI-AB  

Official title:

A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01511224
• Other study ID #: NTUH-TD-B-111-001
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 17, 2012
• Start date: August 2010
• Est. completion date: June 2013

Study information

• Verified date: January 2012
• Source: National Taiwan University Hospital
• Contact: Aristine Cheng, MBBChir
• Phone: +886 975765607
• Email: aristine[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acinetobacter Bacteraemia
• Bacteremia

Locations

Country	Name	City	State
Taiwan	Yunlinn NTUH Branch	Douliou
Taiwan	Far Eastern Memorial Hospital	New Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological clearance from blood	Interval from positive to negative blood A. baumannii PCR and blood sterilization.	Day 0,1,2,3,7	No
Secondary	Survival	Survival at 14, 30-day after enrollment. Survival to discharge.	14, 30, in-hospital stay	No
Secondary	Adverse drug reactions	Nephrotoxicity by RIFLE criteria	Day 0,1,2,3,7,14	Yes
Secondary	Subsequent infections and colonization		During same admission or within 1 week of discharge	No