Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
|ClinicalTrials.gov Identifier: NCT03559530|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 22, 2019
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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||241 participants|
|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|
Patients with microbiologically proven A. baumannii-related osteomyelitis
Antimicrobial therapy according to A. baumannii susceptibility profile
- 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
- 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).
- 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
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559530
|Contact: Priscila R Oliveira, MDfirstname.lastname@example.org|
|Contact: Vladimir C Carvalho, MD PhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Ana Lucia L Lima, MD PhD||Associate Professor|