Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).

Phase 1

• Conditions: MedDRA version: 14.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.0Level: LLTClassification code 10066156Term: Empiric treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005152-34-ES
• Lead Sponsor: José Miguel Cisneros Herreros

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-22
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult patients (equal or older than 18 years) of both sexes.
2. Hospital admission in the Department of Clinical Hematology
3. With any of the following diagnoses:
a. leukemia
b. lymphoproliferative syndrome
c. multiple Myeloma
d. myelodysplastic syndrome
e. bone marrow aplasia
f. Patients likely to receive autologous or allogeneic hematopoietic stem cell trasplant.
4. Febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.
5. Informed consent signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Fever with etiologic diagnosis. Including fever from infectious etiology, fever caused by non-infectious causes such as transfusions, drugs, graft versus host disease (GVHD) or fever due to underlying disease.
2. Patients in whom, predictably, the duration of treatment will be adjusted following the recommendations established for the specific diagnosis of fever.
3. Patients with known allergies or history of hypersensitivity to acyclovir, valaciclovir, valganciclovir, ganciclovir, amphotericin, aztreonam, ciprofloxacin, piperacillin-tazobactam, amikacin, aminoglycosides, imipenem, itraconazole, cilastatin sodium, meropenem, vancomycin, caspofungin, levofloxacin, voriconazole, posaconazole, any other beta-lactam antibiotic (eg.: penicillins and cephalosporins), any other beta-lactamase inhibitor or any other quinolone.
4. Patients with epilepsy
5. Patients with a history of tendon disorders related to fluoroquinolone administration.
6. Pregnant or lactating women.
7. Patients with HIV infection.
8. Patients with severe renal impairment (defined as creatinine clearance below 30 ml / min)
9. Patients receiving medication substrates of CYP3A4 (ergot alkaloids ergotamine and dihydroergotamine, terfenadine, astemizole, cisapride, pimozide or quinidine, rifampin, carbamazepine, phenobarbital, high doses of ritonavir (400 mg and above twice daily) herb St. John's Wort.
10. Participation, currently or three months before, in other clinical trials in the therapy or intervention that could interfere with the results of this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether an individualized clinical protocol is better than the recovery from neutropenia (standard criteria) to decide the withdrawal of empirical antimicrobial therapy in haematological patients with febrile neutropenia (FN).;Secondary Objective: 1. To demonstrate that the individualized clinical protocol is as safe as the standard criteria, comparing:<br>a. The crude mortality within 28 days after the initiation of empiric antibiotic treatment.<br>b. The number of days of fever within 28 days after the initiation of empiric antibiotic treatment.<br>2. To analyze the relationship of procalcitonin (PCT) with the appearance of relapsing fever and its potential usefulness as a guide to decide the duration of empiric antibiotic treatment in patients with haematologic NF.;Primary end point(s): Number of days on which patient is free of antimicrobial treatment;Timepoint(s) of evaluation of this end point: all the protocol visits

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Crude mortality within 28 days after the initiation of empiric antibiotic treatment.<br>- Number of days of fever within 28 days following the initiation of empiric antibiotic treatment.<br>- Value of a more favorable of procalcitonin level to predict relapsing fever.;Timepoint(s) of evaluation of this end point: 1. Mortality in the final visit. 2. Fever at visit 1. 3 Procalcitonin value in the Screening visit, randomization, at 72h. of apirexy (visit 1), at clinical recovery, at relapsing fever and at 28 days (final visit)