Acinetobacter InfectionsNCT02573064
Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical
An observational study of Acinetobacter Infections, run by Maimónides Biomedical Research Institute of Córdoba.
Trial summary
The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acinetobacter Infections
- What is being tested?
- Colistin, Tigecycline and Vancomycin
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- 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: Critical patients with monomicrobial bloodstream infections due to monoclonal antibodies were studied; specific criteria were applied for analysis of empirical therapy and targeted therapy (113 patients).
Who may be able to join
- Critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.
Who cannot join
None listed.
About this study
The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. The different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.
- Conditions
- Acinetobacter Infections
- Being tested
- Colistin, Tigecycline, Vancomycin
- Medical subject headings
- Acinetobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
TigecyclineDrug
VancomycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause 30-day mortality (crude).
Measured: 30 days
Secondary outcomes (1)
All-cause 14 day mortality (crude).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acinetobacter InfectionsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573064
- Sponsor's protocol ID
- FCO-COL-2015-01
- Status last verified
- Oct 2015
- First submitted
- 28 Aug 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Amat T, Gutierrez-Pizarraya A, Machuca I, Gracia-Ahufinger I, Perez-Nadales E, Torre-Gimenez A, Garnacho-Montero J, Cisneros JM, Torre-Cisneros J. The combined use of tigecycline with high-dose colistin might not be associated with higher survival in critically ill patients with bacteraemia due to carbapenem-resistant Acinetobacter baumannii. Clin Microbiol Infect. 2018 Jun;24(6):630-634. doi: 10.1016/j.cmi.2017.09.016. Epub 2017 Sep 29.
PubMed 28970161
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical
- ClinicalTrials.gov ID
- NCT02573064
- Acronym / sponsor ID
- FCO-COL-2015-01
- Conditions
- Acinetobacter Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- First posted
- 9 Oct 2015 (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.
The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. The different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critical patients with monomicrobial bloodstream infections due to monoclonal antibodies were studied; specific criteria were applied for analysis of empirical therapy and targeted therapy (113 patients).
Key inclusion criteria (1 listed)
- Critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colistin | Drug | – |
| Tigecycline | Drug | – |
| Vancomycin | Drug | – |
Primary outcome
All-cause 30-day mortality (crude).
Time frame: 30 days
1 secondary outcome
All-cause 14 day mortality (crude).
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Derived from this study: PubMed 28970161Amat T, Gutierrez-Pizarraya A, Machuca I, Gracia-Ahufinger I, Perez-Nadales E, Torre-Gimenez A, Garnacho-Montero J, Cisneros JM, Torre-Cisneros J. The combined use of tigecycline with high-dose colistin might not be associated with higher survival in critically ill patients with bacteraemia due to carbapenem-resistant Acinetobacter baumannii. Clin Microbiol Infect. 2018 Jun;24(6):630-634. doi: 10.1016/j.cmi.2017.09.016. Epub 2017 Sep 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acinetobacter Infections, run by Maimónides Biomedical Research Institute of Córdoba.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 30-day mortality (crude). (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573064, which also lists 1 linked publication.
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 9 Oct 2015.