Acinetobacter BacteraemiaANTI-ABNCT01511224
A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia
An observational study of Acinetobacter Bacteraemia, run by National Taiwan University Hospital at 3 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acinetobacter Bacteraemia
- How many people
- 200 participants
- Where
- 3 sitesTaiwan
- Study dates
- Aug 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.
Who may be able to join
- Adults ( >16 years)
- With blood culture isolate(s) A. baumannii
- Informed consent gained
Who cannot join
- Second/repeat episodes of bacteremia
- Patients who could not or did not receive antimicrobial treatment
- Patient not admitted to hospital
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites, 3 recruiting
- Recruiting
Yunlinn NTUH Branch
Douliu
Chia-Ling Yang, MD, y01944@ms1.ylh.gov.tw
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Aristine Cheng, MD, aristine@hotmail.com
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hsin-Yun Sun, MD, +886 97265112, hysun13@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acinetobacter Bacteraemia
- Keywords
- Bloodstream infections, Acinetobacter, Drug resistant Acinetobacter baumannii bacteremia
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colistin monotherapy | Not described | |
| Colistin based combination therapy | Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn | |
| Non-colistin containing regime | Not described | |
| Glycopeptide with colistin combination | Not described | |
| Colistin with loading dose | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological clearance from blood
Interval from positive to negative blood A. baumannii PCR and blood sterilization.
Measured: Day 0,1,2,3,7
Secondary outcomes (3)
Survival
Survival at 14, 30-day after enrollment. Survival to discharge.
Measured: 14, 30, in-hospital stay
Adverse drug reactions
Nephrotoxicity by RIFLE criteria
Measured: Day 0,1,2,3,7,14
Subsequent infections and colonization
Measured: During same admission or within 1 week of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startAug 2010
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter BacteraemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Hsin-Yun Sun, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511224
- Sponsor's protocol ID
- NTUH-TD-B-111-001
- Acronym
- ANTI-AB
- Status last verified
- Jan 2012
- First submitted
- 12 Jan 2012
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy
- ClinicalTrials.gov ID
- NCT01511224
- Acronym / sponsor ID
- ANTI-AB / NTUH-TD-B-111-001
- Conditions
- Acinetobacter Bacteraemia
- Keywords
- Bloodstream infections, Acinetobacter, Drug resistant Acinetobacter baumannii bacteremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.
Key inclusion criteria (3 listed)
- Adults ( >16 years)
- With blood culture isolate(s) A. baumannii
- Informed consent gained
Key exclusion criteria (3 listed)
- Second/repeat episodes of bacteremia
- Patients who could not or did not receive antimicrobial treatment
- Patient not admitted to hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiological clearance from blood
Time frame: Day 0,1,2,3,7
Interval from positive to negative blood A. baumannii PCR and blood sterilization.
3 secondary outcomes
Survival
Time frame: 14, 30, in-hospital stay
Adverse drug reactions
Time frame: Day 0,1,2,3,7,14
Subsequent infections and colonization
Time frame: During same admission or within 1 week of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
Related trials for Acinetobacter Bacteraemia
RecruitingPhase 4
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Yun Sun, MD principal investigator
National Taiwan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acinetobacter Bacteraemia, run by National Taiwan University Hospital at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aristine Cheng, MBBChir (+886 975765607, aristine@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological clearance from blood (time frame: Day 0,1,2,3,7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.