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Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

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ClinicalTrials.gov Identifier: NCT03898219
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease
Osteomyelitis Hematogenous Osteomyelitis Relapse

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : April 6, 2016
Actual Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of patients having an osteomyelitis [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Description of the population


Secondary Outcome Measures :
  1. rate of bacteria responsible for infection [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    bacterial epidemiology

  2. rate of management with surgery [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Description of type of surgery

  3. Rate of Treatment Failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898219


Locations
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France
Hospices Civils de Lyon - Hopital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03898219     History of Changes
Other Study ID Numbers: 69HCL17_0262
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Hematogenous osteomyelitis
relapse
adulthood

Additional relevant MeSH terms:
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Recurrence
Osteomyelitis
Disease Attributes
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases