NCT02573064

Brief 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 . 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

August 28, 2015

Last Update Submit

October 8, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause 30-day mortality (crude).

    30 days

Secondary Outcomes (1)

  • All-cause 14 day mortality (crude).

    14 days

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acinetobacter Infections

Interventions

ColistinTigecyclineVancomycin

Condition Hierarchy (Ancestors)

Moraxellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlycopeptidesGlycoconjugatesCarbohydrates

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

October 9, 2015

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Last Updated

October 9, 2015

Record last verified: 2015-10