Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia (HOWLONG)

NCT01581333 Phase 4 COMPLETED

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).

Details

Lead sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase	Phase 4
Status	COMPLETED
Enrolment	157
Start date	2012-04
Completion	2016-06

Conditions

• Febrile Neutropenia

Interventions

• Empirical antimicrobial treatment discontinuation
• Standard empirical antimicrobial treatment discontinuation

Primary outcomes

• Number of days on which patient is free of antimicrobial treatment — 28 days following the initiation of empiric antibiotic 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).

Countries

Spain