Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia (HOWLONG)
| Tracking Information | |||||
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| First Received Date ICMJE | April 17, 2012 | ||||
| Last Updated Date | January 3, 2013 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of days on which patient is free of antimicrobial treatment [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ] [ Designated as safety issue: No ] Protocol visits: Screening visit, Randomization visit, at 72h. of apirexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit). |
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| Original Primary Outcome Measures ICMJE |
Number of days on which patient is free of antimicrobial treatment [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ] [ Designated as safety issue: No ] Protocol visits: Screnning visit, Rarndomization visit, at 72h. of apirexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit). |
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| Change History | Complete list of historical versions of study NCT01581333 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia | ||||
| Official Title ICMJE | Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia | ||||
| Brief Summary | 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). |
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| Detailed Description | 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Febrile Neutropenia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 156 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01581333 | ||||
| Other Study ID Numbers ICMJE | 2011-005152-34 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||
| Study Sponsor ICMJE | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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