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Completed

NCT Number: NCT03898219

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.

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Key information

Conditions

Osteomyelitis Bone Diseases Bone Diseases, Infectious Disease Attributes Hematogenous Osteomyelitis Relapse Infections Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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