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).

Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005152-34-ES

Enrollment

Unknown

Registered

2011-11-22

Start date

2012-03-26

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 14.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0 Level: LLT Classification c

Interventions

Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: ACICLOVIR CAS Number: 59277-89-3 Current Sponsor code: NA Other descriptive name: ACICLOVIR Concentration unit: mg/kg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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: a. The crude mortality within 28 days after the initiation of empiric antibiotic treatment. b. The number of days of fever within 28 days after the initiation of empiric antibiotic treatment. 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	—

Measure

Time frame

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: a. The crude mortality within 28 days after the initiation of empiric antibiotic treatment. b. The number of days of fever within 28 days after the initiation of empiric antibiotic treatment. 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

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Secondary

Measure	Time frame
Secondary end point(s): - Crude mortality within 28 days after the initiation of empiric antibiotic treatment. - Number of days of fever within 28 days following the initiation of empiric antibiotic treatment. - 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)	—

Measure

Time frame

Secondary end point(s): - Crude mortality within 28 days after the initiation of empiric antibiotic treatment. - Number of days of fever within 28 days following the initiation of empiric antibiotic treatment. - 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)

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Countries

Spain

Contacts

Public ContactFernando Pérez Martínez

Unidad de Investigación Clínica y Ensayos Clínicos

fernando.perez.exts@juntadeandalucia.es34955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026