OsteomyelitisNCT03559530
Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
An observational study of Osteomyelitis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- Antimicrobial
- How many people
- 262 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 1. Microbiologically confirmed osteomyelitis related to Acinetobacter baumannii
Who cannot join
- Impossibility to review data in medical records;
- Culture results with A. baumannii considered as colonization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403010
About this study
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.
Read more
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.
Read the detailed description
INTRODUCTION Acinetobacter baumannii is an opportunist pathogen that has become increasingly important over recent years as a cause of nosocomial infections (1,2). Ventilator-associated pneumonia, central line-associated bloodstream infection and bone and soft tissue infection 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. Among the striking characteristics of this species is its high capacity to develop antimicrobial resistance. The most important types of resistance are, firstly, intrinsic resistance related to the association between diminished permeability of the external membrane and constitutive expression of efflux pumps; and secondly, acquisition of genetic elements, which might be resistance genes or insertion elements that, in association with the chromosomal genes of this bacterium, can trigger expression of resistance and great ability to survive in the environment, which is commonly related to production of biofilm (7). All these characteristics have been correlated with emergence of multiresistant and pan-resistant strains of A. baumannii. 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. The formerly abundant flow of provision of new antibiotics of ever-broader spectrum has been shown to be a non-renewable resource.
Certain risk factors have also been correlated with occurrence of 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, showing a high profile of antimicrobial resistance, particularly to carbapenems.
At the Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo, a Brazilian reference center that provides care for high-complexity orthopedic cases, 241 cases of osteomyelitis related to A. baumannii were treated between 2007 and 2014. All cases had microbiological confirmation, with positive cultures of bone tissue.
OBJECTIVES
- Clinical and epidemiological characterization of 241 cases of osteomyelitis related to A. baumannii who were admitted at the Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo;
- To describe the antimicrobial susceptibility profile of A. baumannii strains isolated;
- To evaluate the patients' outcomes (remission, recurrence, limb amputation or death) according to the antimicrobial treatment used, including tigecycline.
- To compare efficacy and safety profiles of tigecycline, colistin and ampicillin-sulbactan among patients with carbapenem-resistant A. baumannii related osteomyelitis.
METHODS 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 positive culture of bone tissue for A. baumannii. Bone samples were obtained from biopsy fragments identified as bone or medullary canal tissue (cortical bone and medullary canal aspirates) obtained through surgical procedures. All specimens were sent to the microbiology laboratory in thioglycolate culturing medium. The first reading was made 24 hours after incubation started and if the samples showed bacterial growth, the material was seeded in blood agar and MacConkey agar media. Bacterioscopic examinations were also performed. Subsequently, Gram-negative bacteria were identified by means of Vitek. Non-fermenting and Gram-positive bacteria were identified manually and a susceptibility test was performed using disk-diffusion. The minimum inhibitory concentrations were released in accordance with the CLSI criteria.
The following variables will be collected and analyzed for clinical characterization and outcomes evaluation:
- Gender;
- Age;
- Affected bones;
- Time of disease symptoms until hospital admission;
- Osteomyelitis-related symptoms;
- Previous antimicrobial use (before A. baumannii-positive culture);
- Classification of osteomyelitis (according to Waldwogel´s system);
- Presence of comorbidities (diabetes mellitus, active neoplasia, HIV infection, intravenous drug use, smoking, peripheral venous/arterial disease, alcoholism, open fracture, previous orthopedic surgery, imunossupressive conditions);
- ASA score;
- A. baumannii susceptibility profile;
- Antimicrobial drugs prescribed for A. baumannii-related infection;
- Antimicrobial drugs prescribed for concomitant infections;
- Antimicrobial-related side effects;
- Creatinine evolution following A. baumannii-related infection treatment;
- ESR, CPR and hemogram evolution following A. baumannii-related infection treatment;
- AST and ALT evolution following A. baumannii-related infection treatment;
- Radiological evolution of affected bone following A. baumannii-related infection treatment;
- 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.
Data analysis will be descriptive for all above mentioned variables among the 241 patients with A. baumanni-related osteomyelitis. Among those with infection related to carbapenem resistant-isolates, the variables concerning safety and efficacy of chosen antimicrobial regimen, colistin, ampicillin-sulbactan or tigeciclyne (antimicrobial-related side effects; creatinine evolution; ESR, CPR and hemogram evolution will be compared using chi-square test or Fisher's exact test for categoric variables and ANOVA test for continuous variables. Radiological variables and outcomes will be compared using chi-square test or Fisher's exact test.
- Conditions
- Osteomyelitis
- Being tested
- Antimicrobial
- Keywords
- osteomyelitis, Acinetobacter baumannii, Anti-Infective Agents
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntimicrobialDrug
Antimicrobial therapy according to A. baumannii susceptibility profile
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with microbiologically proven A. baumannii-related osteomyelitis Receives: Drug: Antimicrobial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the Clinical and Epidemiological Profile of Patients With Infection
Distribution of the clinical and epidemiological characteristics studied among the patients. Use of percentage and average for description.
Measured: 6 months
Secondary outcomes (1)
A. Baumannii Susceptibility Profile
- baumannii isolates susceptible to the tested antimicrobials
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 May 2017
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Priscila Rosalba Domingos de Oliveira, University of Sao Paulo
- Investigators
- Ana Lucia L Lima, MD PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559530
- Sponsor's protocol ID
- 14186
- Status last verified
- Apr 2021
- First submitted
- 4 May 2018
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
- ClinicalTrials.gov ID
- NCT03559530
- Acronym / sponsor ID
- 14186
- Conditions
- Osteomyelitis
- Keywords
- osteomyelitis, Acinetobacter baumannii, Anti-Infective Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION Acinetobacter baumannii is an opportunist pathogen that has become increasingly important over recent years as a cause of nosocomial infections (1,2). Ventilator-associated pneumonia, central line-associated bloodstream infection and bone and soft tissue infection 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. Among the striking characteristics of this species is its high capacity to develop antimicrobial resistance. The most important types of resistance are, firstly, intrinsic resistance related to the association between diminished permeability of the external membrane and constitutive expression of efflux pumps; and secondly, acquisition of genetic elements, which might be resistance genes or insertion elements that, in association with the chromosomal genes of this bacterium, can trigger expression of resistance and great ability to survive in the environment, which is commonly related to production of biofilm (7). All these characteristics have been correlated with emergence of multiresistant and pan-resistant strains of A. baumannii. 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. The formerly abundant flow of provision of new antibiotics of ever-broader spectrum has been shown to be a non-renewable resource.
Certain risk factors have also been correlated with occurrence of 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, showing a high profile of antimicrobial resistance, particularly to carbapenems.
At the Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo, a Brazilian reference center that provides care for high-complexity orthopedic cases, 241 cases of osteomyelitis related to A. baumannii were treated between 2007 and 2014. All cases had microbiological confirmation, with positive cultures of bone tissue.
OBJECTIVES
- Clinical and epidemiological characterization of 241 cases of osteomyelitis related to A. baumannii who were admitted at the Institute of Orthopedics and Traumatology, Hospital das Clínicas, University of São Paulo;
- To describe the antimicrobial susceptibility profile of A. baumannii strains isolated;
- To evaluate the patients' outcomes (remission, recurrence, limb amputation or death) according to the antimicrobial treatment used, including tigecycline.
- To compare efficacy and safety profiles of tigecycline, colistin and ampicillin-sulbactan among patients with carbapenem-resistant A. baumannii related osteomyelitis.
METHODS 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 positive culture of bone tissue for A. baumannii. Bone samples were obtained from biopsy fragments identified as bone or medullary canal tissue (cortical bone and medullary canal aspirates) obtained through surgical procedures. All specimens were sent to the microbiology laboratory in thioglycolate culturing medium. The first reading was made 24 hours after incubation started and if the samples showed bacterial growth, the material was seeded in blood agar and MacConkey agar media. Bacterioscopic examinations were also performed. Subsequently, Gram-negative bacteria were identified by means of Vitek. Non-fermenting and Gram-positive bacteria were identified manually and a susceptibility test was performed using disk-diffusion. The minimum inhibitory concentrations were released in accordance with the CLSI criteria.
The following variables will be collected and analyzed for clinical characterization and outcomes evaluation:
- Gender;
- Age;
- Affected bones;
- Time of disease symptoms until hospital admission;
- Osteomyelitis-related symptoms;
- Previous antimicrobial use (before A. baumannii-positive culture);
- Classification of osteomyelitis (according to Waldwogel´s system);
- Presence of comorbidities (diabetes mellitus, active neoplasia, HIV infection, intravenous drug use, smoking, peripheral venous/arterial disease, alcoholism, open fracture, previous orthopedic surgery, imunossupressive conditions);
- ASA score;
- A. baumannii susceptibility profile;
- Antimicrobial drugs prescribed for A. baumannii-related infection;
- Antimicrobial drugs prescribed for concomitant infections;
- Antimicrobial-related side effects;
- Creatinine evolution following A. baumannii-related infection treatment;
- ESR, CPR and hemogram evolution following A. baumannii-related infection treatment;
- AST and ALT evolution following A. baumannii-related infection treatment;
- Radiological evolution of affected bone following A. baumannii-related infection treatment;
- 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.
Data analysis will be descriptive for all above mentioned variables among the 241 patients with A. baumanni-related osteomyelitis. Among those with infection related to carbapenem resistant-isolates, the variables concerning safety and efficacy of chosen antimicrobial regimen, colistin, ampicillin-sulbactan or tigeciclyne (antimicrobial-related side effects; creatinine evolution; ESR, CPR and hemogram evolution will be compared using chi-square test or Fisher's exact test for categoric variables and ANOVA test for continuous variables. Radiological variables and outcomes will be compared using chi-square test or Fisher's exact test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: AntimicrobialPatients with microbiologically proven A. baumannii-related osteomyelitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Microbiologically confirmed osteomyelitis related to Acinetobacter baumannii
Key exclusion criteria (2 listed)
- Impossibility to review data in medical records;
- Culture results with A. baumannii considered as colonization.
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 |
|---|---|---|
| AntimicrobialAntimicrobial therapy according to A. baumannii susceptibility profile | Drug | Patients |
Primary outcome
Description of the Clinical and Epidemiological Profile of Patients With Infection
Time frame: 6 months
Distribution of the clinical and epidemiological characteristics studied among the patients. Use of percentage and average for description.
1 secondary outcome
A. Baumannii Susceptibility Profile
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ana Lucia L Lima, MD PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by University of Sao Paulo at 1 site in Brazil.
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 2 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Description of the Clinical and Epidemiological Profile of Patients With Infection (time frame: 6 months). 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 May 2021.