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Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization

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ClinicalTrials.gov Identifier: NCT03559530
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Priscila Rosalba Domingos de Oliveira, University of Sao Paulo

Brief Summary:

Acinetobacter baumannii is an opportunist pathogen that has become increasingly important over recent years as a cause of nosocomial infections. Ventilator-associated pneumonia, central line-associated bloodstream infection and bone and soft tissue infections secondary to open fractures are among the conditions most associated with this agent .

Attention is drawn not only to the increasing incidence of this agent over the last few years but also to the rapid worsening of its susceptibility to antimicrobial agents, including carbapenems. Few therapeutic options are available for treating pan-resistant strains: colistin and tigecycline has been used, but resistance to these options frequently emerges in clinical practice. Taking into account the fact that fewer new antimicrobial agents are being validated and introduced into clinical practice, the growing prevalence of isolates with these high levels of resistance is becoming a matter of increasing concern.

Certain risk factors have also been correlated with infection related to A. baumannii. The most important are prolonged hospitalization in intensive care units and use of invasive devices. Another important risk factor is severe trauma: A. baumannii is associated with invasive infections, including osteomyelitis following open fracture reduction. Studies that included military personnel and civilians involved in the recent conflicts in Iraq and Afghanistan have shown high prevalence of A. baumannii as causative agent in cases of osteomyelitis secondary to traumatic injuries. Also, in Brazil, a retrospective study that analyzed 101 cases of osteomyelitis due to Gram-negative bacilli showed that A. baumannii was the second most prevalent agent and that it had a high degree of antimicrobial resistance, particularly to carbapenems.

The objectives of this retrospective study are: 1. clinically and epidemiologically characterize 241 patients with osteomyelitis related to A. baumannii who were admitted at the Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo; 2. to describe the antimicrobial susceptibility profile of A. baumannii strains isolated; 3. to evaluate the patients' outcomes (remission, recurrence, limb amputation or death) according to the antimicrobial treatment used, including tigecycline; 4. to compare efficacy and safety profiles of tigecycline, colistin and ampicillin-sulbactan among patients with carbapenem-resistant A. baumannii related osteomyelitis.


Condition or disease Intervention/treatment
Osteomyelitis Drug: Antimicrobial

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 241 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Patients
Patients with microbiologically proven A. baumannii-related osteomyelitis
Drug: Antimicrobial
Antimicrobial therapy according to A. baumannii susceptibility profile




Primary Outcome Measures :
  1. Description of the clinical and epidemiological profile of patients with infection [ Time Frame: 6 months ]
    descriptive analysis of patients with A. baumannii osteomyelitis, including gender, age, presence of comorbidities, physical status, infection topography and previous treatments


Secondary Outcome Measures :
  1. A. baumannii susceptibility profile [ Time Frame: 6 months ]
    The susceptibility to tested antimicrobials will be described for all patients and evaluated with the use of summary measures (mean, standard deviation, median, minimum and maximum).

  2. Patient outcome according to antimicrobial therapy to A. baumannii [ Time Frame: 3 months ]
    Outcomes (remission, recidive, death, lost follow up) will be compared according to the antimicrobial therapy used with the use of chi-square tests or exact tests (Fisher's exact test or likelihood ratio test).according to the antimicrobial treatment used

  3. Comparison of efficacy of the antimicrobial drugs used against carbapenem-resistant A. baumannii [ Time Frame: 3 months ]
    Efficacy will be evaluated according to outcomes 6-month after A. baumannii-related infection treatment (disease remission, amputation of the affected limb, infection relapse, death and loss to follow-up). Disease remission will be defined as absence of signs of infection at the end of follow-up period

  4. Comparison of safety profile of the antimicrobial drugs used against carbapenem-resistant A. baumannii [ Time Frame: 3 months ]
    Safety profile of each drug will be evaluated according to adverse effects related during therapy ( serum creatinine evolution following A. baumannii-related infection treatment; serum AST and ALT evolution following A. baumannii-related infection treatment)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include data about all 241 patients with A. baumannii-related osteomyelitis admitted at our institution from 2007 to 2014. According to the institution´s protocol, diagnosis of osteomyelitis was based on the clinical history, infectious signs and symptoms and bone tissue culturing that was positive for A. baumannii.
Criteria

Inclusion Criteria:

1. Microbiologically confirmed osteomyelitis related to Acinetobacter baumannii

Exclusion Criteria:

  1. Impossibility to review data in medical records;
  2. Culture results with A. baumannii considered as colonization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559530


Contacts
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Contact: Priscila R Oliveira, MD 5511974615975 priscila.rosalba@hc.fm.usp.br
Contact: Vladimir C Carvalho, MD PhD 5511983214518 vladimir.carvalho@hc.fm.usp.br

Locations
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Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403010
Contact: Priscila R Oliveira, MD    5511974615975      
Contact: Vladimir C Carvalho, MD PhD    5511983214518    vladimir.carvalho@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Pfizer
Investigators
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Principal Investigator: Ana Lucia L Lima, MD PhD Associate Professor

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Responsible Party: Priscila Rosalba Domingos de Oliveira, Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03559530     History of Changes
Other Study ID Numbers: 14186
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Priscila Rosalba Domingos de Oliveira, University of Sao Paulo:
osteomyelitis
Acinetobacter baumannii
Anti-Infective Agents

Additional relevant MeSH terms:
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Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Anti-Infective Agents
Anti-Bacterial Agents