NCT01581333

Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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).

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DRUG	Empirical antimicrobial treatment discontinuation	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.
DRUG	Standard empirical antimicrobial treatment discontinuation	The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2012-04-20
• Last updated: 2017-11-01

Locations

6 sites across 1 country: Spain