Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy Clinical Trial
Official title:
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule
| Verified date | February 2018 |
| Source | University Hospital, Lille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia
| Status | Completed |
| Enrollment | 1900 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility |
Inclusion Criteria: - Child aged 1 to 18 years - Child with hematology or cancer - Child with a febrile neutropenia post-chemotherapy - Child with social security - No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor. Exclusion Criteria: - Febrile neutropenia at diagnosis of tumor disease - Child with palliative care - Child having had a hematopoietic stem cell allo-graft in the preceding year - Febrile neutropenia immediately post auto-transplant - Antibiotherapy prior to admission - Initial care in a non-investigative center. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Jeanne de Flandre - CHRU de Lille | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille | Ligue contre le cancer, France, Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Blood culture | Presence or not of bacteriemia | On average between 5 days and 1 month | |
| Primary | Positive bacterial culture from a normally sterile site | Presence or not of bacterial infection | on average between 5 days and 1 month | |
| Primary | microbiological culture | Presence or not of focal infection at high risk of dissemination was defined as any local infection with or without microbiological documentation into a normally sterile site, with significant risk of loco-regional or systemic spread | On average between 5 days and 1 month | |
| Primary | Fungal culture | Presence or not of fungal infection is referred to a proven, probable, or possible fungal infection as defined by the IFICG ot the EORTC | On average between 5 days and 1 month |