Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

Osteomyelitis Clinical Trial

Official title:

Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898219
• Other study ID #: 69HCL17_0262
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: April 6, 2016

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 6, 2016
• Est. primary completion date: April 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematogenous Osteomyelitis Relapse
• Osteomyelitis
• Recurrence

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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