Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization

NCT03559530 | Completed Results DMC FDA Drug

• 1 other identifier: 14186
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteomyelitis

Keywords

osteomyelitis; Acinetobacter baumannii; Anti-Infective Agents

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• A. Baumannii Susceptibility Profile

  6 months

Study Arms (1)

Patients

Patients with microbiologically proven A. baumannii-related osteomyelitis

Drug: Antimicrobial

Interventions

Antimicrobial DRUG

Antimicrobial therapy according to A. baumannii susceptibility profile

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Microbiologically confirmed osteomyelitis related to Acinetobacter baumannii

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Pfizer: collaborator

Study Sites (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr Priscila Rosalba Domingos de Oliveira
• Organization: Unversidade de Sao Paulo

priscila.rosalba@hc.fm.usp.br

551126616900

Study Officials

• Ana Lucia L Lima, MD PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 18, 2018
• Study Start: May 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)