Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).
The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Empirical antimicrobial treatment discontinuation |
|
| Control Arm | Active Comparator | Standard empirical antimicrobial treatment discontinuation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empirical antimicrobial treatment discontinuation | Drug | Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days on which patient is free of antimicrobial treatment | Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit). | 28 days following the initiation of empiric antibiotic treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Crude mortality | Number of died patients | 28 days following the initiation of empiric antibiotic treatment. |
| Number of days of fever | Number of days of fever |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| José M Cisneros Herreros, PhD | Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11407 | Spain | ||
| Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29153975 | Derived | Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 2, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard empirical antimicrobial treatment discontinuation | Drug | The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3. |
|
|
| 28 days following the initiation of empiric antibiotic treatment |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clínic | Barcelona | 08036 | Spain |
| Bellvitge University Hospital | Barcelona | 08907 | Spain |
| Hospital Clínico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Virgen del Rocío University Hospital | Seville | 41013 | Spain |
| Oct 20, 2017 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided