- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928291
Procalcitonin Protocol to Shorten the Antibiotic Therapy in Febrile Neutropenia
The Use of a Procalcitonin (PCT)-Guided Protocol to Shorten the Duration of Antibiotic Therapy in Febrile Neutropenic Patients. An Interventional Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods
- Patients and setting: Prospective controlled randomized interventional study of antibiotic therapy in adult with febrile neutropenia.
The study will be conducted in the University Hospital of the Federal University of Minas Gerais, Brazil. This is a 600-bed tertiary hospital, with approximately 1.6 thousands hospitalizations/month. Roughly 120 episodes of febrile neutropenia were recorded in the first semester of 2007, occurring in 100 patients with hematological leucosis or post-BMT. This number rises if one considers other groups of neutropenic patients, such as those with neutropenia due chemotherapy for solid tumors, patients with BM aplasia, myelo dysplasia, among others,
- Interventions:
As long as the core objective of the study is to test if a PCT-guided protocol allows to guide the antibiotic withdrawn in neutropenic patients, only patients with febrile neutropenia under antibiotic therapy will be included in the study. They will be submitted to the following exams:
- Bood samples will be drawn at baseline to blood culture, CRP, blood cells count, ions, liver profile and renal function tests. These exams will be repeated according to the local protocol followed by the Service of Hematology (see appendix).
- A plasma galactomannan test will be performed at baseline in all patients considered for inclusion in the study, and repeated at any moment if there is suspicion of Aspergillus infection during the follow up.
- A chest radiography will also be performed in all participants at baseline, and according to clinical indication afterwards.
- All patients with abnormal chest radiography at baseline will be submitted to a contrasted chest CT (or without contrast if creatinine clearance < 50 ml/min).
- Additional complementary exams will be performed as clinically needed.
- Circulating PCT measurements will be performed at baseline, and then on day 3 (if initial PCT < 0.5) or on day 5 (if initial PCT >0.5).
Eligible patients will be reassessed for on day 3 (if initial PCT < 0.5) or on day 5 (if initial PCT >0.5), and randomized at 1:1 basis to one of the two groups since any exclusion criteria (see below) is present at that time:
Group 1 - PCT group: the interventions on antibiotic therapy will be based on circulating PCT levels.
Group 2 - Control group: antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.
Patients randomized to the study will undergo daily measurements of plasma PCT levels, and kept under antibiotic therapy until a relative reduction of 90% in baseline PCT levels, or a value lower than 0.5 ng/ml is reached, and then maintained for additional 48h (two measure). Therefore, plasma PCT levels will be measured every 5 days up to the 28th day of follow-up or until death or transference, if either occurs first. Patients included in the interventional group will be observed for at least 48 hours following antibiotic discontinuation before being discharged from the hospital. Extra PCT tests will be performed according to the clinical course.
Apart from the antibiotic therapy, all participants will be managed according to the appropriate guidelines. Patients with febrile neutropenia hospitalized in the University Hospital of the Federal University of Minas Gerais are routinely cared by an experienced hematology specialist together with an infectious diseases consultant. This standard care will be offered to all patients included in the study. The final decision regarding antibiotic therapy will be always let to the discretion of these specialists.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30130100
- Hospital das Clinicas da Universidade Federal de Minas Gerais
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 18 years
- febrile neutropenia
- to be under antibiotic therapy
- signed informed consent
Exclusion Criteria:
- patients under antibiotic therapy for more than 72 hours before inclusion
- patients post allogenic bone-marrow transplant (BMT)
patients presenting one or more of the following conditions at the time of randomization:
- severe mucositis
- all-trans retinoic acid (ATRA) syndrome
- disseminated intravascular coagulation
- hypotension (systolic blood pressure < 90 mmHg or need for vasopressor to maintain blood pressure)
- respiratory failure (arterial oxygen pressure < 60 mmHg while breathing room air) or need for mechanical ventilation
- severe renal failure requiring hemodialysis
- patients with suspected (positive galactomannan assay in peripheral blood, nodular lesions with halo in the chest CT) or microbiologically confirmed fungal infection
- bacteremia due to S. aureus
- microbiologically confirmed carbapenem resistant P. aeruginosa or A. baumanii infection
- microbiologically confirmed pneumonia due to P. aeruginosa, A. baumanii or Stenotrophomonas maltophilla
- suspected or confirmed infection caused by atypical microorganisms (virus, parasites, P. jiroveci). Patients with localized HSV infection (e.g., labial) will be accepted for inclusion
- infections requiring prolonged therapies, such as endocarditis and cerebral abscess
- clearly focal bacterial infections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 - PCT group
interventions on antibiotic therapy will be based on circulating PCT levels
|
plasma PCT measurement
antibiotic therapy use
|
Active Comparator: Group 2 - Control group
antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.
|
plasma PCT measurement
antibiotic therapy use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure
Time Frame: 28 days
|
28 days
|
Number of days alive without antibiotics
Time Frame: 28 days
|
28 days
|
Duration of antibiotic therapy for the first episode of fever
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: 6 m
|
6 m
|
All cause and infection-related 28-day mortality
Time Frame: 28 days
|
28 days
|
All cause 90-day mortality
Time Frame: 90 days
|
90 days
|
Clinical cure rate
Time Frame: 28 days
|
28 days
|
Nosocomial superinfection (diagnosed more than 48 hours after discontinuation of the antibiotic(s) given to the first episode of infection)
Time Frame: 28 days
|
28 days
|
Infection relapse (diagnosed less than 48 h after antibiotic discontinuation)
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Investigators
- Study Chair: Vandack Nobre, PhD, Medicine Faculty of Federal University of Minas Gerais
- Study Chair: Stella SS Lima, MD, Medicine Faculty of Federal University of Minas Gerais
- Study Chair: Henrique NS Bittencourt, PhD, Medicine Faculty of Federal University of Minas Gerais
- Principal Investigator: José C Serufo, PhD, Medicine Faculty of Federal University of Minas Gerais
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCT febrile neutropenia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Febrile Neutropenia
-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
-
Institut RafaelActive, not recruitingPatient Satisfaction | Patient Preference | Febrile Neutropenia, Drug-InducedFrance
-
TTY BiopharmCompletedNeutropenia, FebrileTaiwan
-
University Hospital, BrestCompletedNeutropenia, FebrileFrance
-
AmgenCompletedChemotherapy-induced Febrile NeutropeniaFrance, Italy, Poland, Canada, Spain, Austria, Germany, Greece, Romania, Australia, Ireland
-
University Hospital, LilleMinistry of Health, FranceRecruiting
-
Hospital Infantil de Mexico Federico GomezHospital Juarez de Mexico; Instituto Nacional de PediatriaCompletedChemotherapy-Induced Febrile Neutropenia
-
All India Institute of Medical Sciences, New DelhiTerminatedPediatric Cancer | Neutropenia, FebrileIndia
-
Kjeld SchmiegelowRecruitingPediatric Cancer | Neutropenia, FebrileDenmark
-
PfizerCompletedNon-Interventional StudyGermany
Clinical Trials on procalcitonin
-
Erasmus Medical CenterCompleted
-
Centre Hospitalier Departemental VendeeTerminated
-
Cliniques universitaires Saint-Luc- Université...Terminated
-
Karolinska University HospitalCompletedThe Value of Procalcitonin in Patients With Suspected CandidemiaSweden
-
Central Hospital, Nancy, FranceCompletedBacteremia | Contamination | Blood Culture ContaminationFrance
-
Rijnstate HospitalUnknown
-
Aga Khan UniversityCompleted
-
CAMC Health SystemWithdrawnIntraventricular Hemorrhage | Intracerebral HemorrhageUnited States
-
Ege UniversityTHE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYERecruitingBacterial Infections | Children, Only | Procalcitonin | SalivaTurkey
-
National Cancer Center, KoreaCompletedPneumonia | Cancer | ProcalcitoninKorea, Republic of