Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.

Study Overview

• Status: Completed
• Conditions: Osteomyelitis; Hematogenous Osteomyelitis Relapse

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood.

Description

Inclusion Criteria:

• Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood.
• the time limit between the 2 episodes must be at least 2 years
• antecedent of osteomyelitis before 16 years

Exclusion Criteria:

• inability to give the information to the patient
• patients opposed to the use of their data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients having an osteomyelitis	Description of the population	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Treatment Failure	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
rate of bacteria responsible for infection	bacterial epidemiology	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
rate of management with surgery	Description of type of surgery	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): April 6, 2016
• Study Completion (ACTUAL): April 6, 2016

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (ACTUAL): April 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: relapse; adulthood; Hematogenous osteomyelitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Recurrence; Osteomyelitis
• Other Study ID Numbers: 69HCL17_0262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No