Febrile NeutropeniaPhase 4HOWLONGNCT01581333
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia
A Phase 4 study testing Empirical antimicrobial treatment discontinuation and Standard empirical antimicrobial treatment discontinuation in people with Febrile Neutropenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 6 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Empirical antimicrobial treatment discontinuation and Standard empirical antimicrobial treatment discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 6 sitesSpain
- Study dates
- Apr 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.
- Informed consent signed.
Who cannot join
- Fever with etiologic diagnosis.
- Patients with epilepsy.
- Pregnant or lactating women.
- Patients with HIV infection.
- Patients with severe renal failure.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínic
Barcelona, 08036
Bellvitge University Hospital
Barcelona, 08907
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
Virgen del Rocío University Hospital
Seville, 41013
About this study
Official title: Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia
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).
Read the 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
- Being tested
- Empirical antimicrobial treatment discontinuation, Standard empirical antimicrobial treatment discontinuation
- Keywords
- febrile neutropenia, antimicrobial treatment, procalcitonin
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical antimicrobial treatment discontinuationDrug
Also called Clinical rules for finalization of antimicrobial therapy
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.
Standard empirical antimicrobial treatment discontinuationDrug
Also called Laboratory rules for finalization of antimicrobial therapy
The empirical antimicrobial treatment discontinuation will occur when the patient is:
The neutrophil count is above 500 million per mm3.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Empirical antimicrobial treatment discontinuation Receives: Drug: Empirical antimicrobial treatment discontinuation |
| Control Arm | Active comparator | Standard empirical antimicrobial treatment discontinuation Receives: Drug: Standard empirical antimicrobial treatment discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days on which patient is free of antimicrobial 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).
Measured: 28 days following the initiation of empiric antibiotic treatment.
Secondary outcomes (2)
Crude mortality
Number of died patients
Measured: 28 days following the initiation of empiric antibiotic treatment.
Number of days of fever
Number of days of fever
Measured: 28 days following the initiation of empiric antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José M Cisneros Herreros, PhD, Study director, Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581333
- Sponsor's protocol ID
- 2011-005152-34
- Acronym
- HOWLONG
- Status last verified
- Oct 2017
- First submitted
- 17 Apr 2012
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15.
PubMed 29153975
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT01581333
- Acronym / sponsor ID
- HOWLONG / 2011-005152-34
- Conditions
- Febrile Neutropenia
- Keywords
- febrile neutropenia, antimicrobial treatment, procalcitonin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Empirical antimicrobial treatment discontinuationEmpirical antimicrobial treatment discontinuation |
| Control Arm | Active comparator | Drug: Standard empirical antimicrobial treatment discontinuationStandard empirical antimicrobial treatment discontinuation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Fever with etiologic diagnosis.
- Patients with epilepsy.
- Pregnant or lactating women.
- Patients with HIV infection.
- Patients with severe renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empirical antimicrobial treatment discontinuationAlso: Clinical rules for finalization of antimicrobial therapyEmpirical 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 | Experimental Arm |
| Standard empirical antimicrobial treatment discontinuationAlso: Laboratory rules for finalization of antimicrobial therapyThe empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3. | Drug | Control Arm |
Primary outcome
Number of days on which patient is free of antimicrobial treatment
Time frame: 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).
2 secondary outcomes
Crude mortality
Time frame: 28 days following the initiation of empiric antibiotic treatment.
Number of days of fever
Time frame: 28 days following the initiation of empiric antibiotic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Derived from this study: PubMed 29153975Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M Cisneros Herreros, PhD study director
Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empirical antimicrobial treatment discontinuation and Standard empirical antimicrobial treatment discontinuation in people with Febrile Neutropenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days on which patient is free of antimicrobial treatment (time frame: 28 days following the initiation of empiric antibiotic treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01581333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.