Urinary Tract InfectionPhase 3PICNICNCT02568800
Prolonged Infusion Cefepime and Nosocomial Infections
A Phase 3 study testing Prolonged Cefepime Infusion and Usual Cefepime Infusion in people with Urinary Tract Infection and Respiratory Tract Infection, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Tract Infection, Respiratory Tract Infection
- What is being tested?
- Prolonged Cefepime Infusion and Usual Cefepime Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Sep 2016
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary tract infection after 48-72 hours of hospital stay
- Respiratory tract infection after 48-72 hours of hospital stay
- Catheter related urinary tract infection after 48-72 hours of hospital stay
- Urinary or respiratory infections not responding to a narrower spectrum antibiotic
- Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection
Who cannot join
- Glomerular filtration rate lower than 30 ml.min/1,73m²
- ICU admission for at least 72 hours before randomization
- Neutrophil count lower than 1000 cels per mm³
- Hematologic malignancy, bronchiectasis and cystic fibrosis
- Patients allergic to cefepime
- Concomitant treatment to another infectious disease
Show all 9Show fewer
- Central nervous system, cutaneous or intrabdominal infections
- Solid organ transplantation
- HIV with a cluster differentiation 4 (CD4) lower than 100 cels per mm³
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
André Dias Américo, +555133598152, adamerico@hcpa.edu.br
About this study
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
Read the detailed description
Introduction: it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (T>MIC). Although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit.
Objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes.
Methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. Patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed.
Interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. The randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of SIRS criteria.
- Being tested
- Prolonged Cefepime Infusion, Usual Cefepime Infusion
- Medical subject headings
- Urinary Tract Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Cefepime InfusionDrug
Also called Estended Cefepime Infusion
Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
Usual Cefepime InfusionDrug
Also called Regular Cefepime Infusion
Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Cefepime Infusion | Experimental | Cefepime infusions should last 4 hours at least Receives: Drug: Prolonged Cefepime Infusion |
| Usual Cefepime Infusion | Active comparator | Cefepime infusion should last no more than 30 minutes Receives: Drug: Usual Cefepime Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death in 30 days since randomization
Measured: 30 days
Secondary outcomes (7)
Death
Death in 14 days since randomization
Measured: 14 days
Duration of hospital stay
Duration of hospital stay
Measured: 30 days since randomization
Intensive care unit (ICU) admission
Intensive care necessity for any reason
Measured: 30 days since randomization
Duration of intensive care unit (ICU) stay
Number of days when intensive care was considered necessary
Measured: 30 days since randomization
Treatment change
Treatment change required based com clinical or microbiological data
Measured: 3 days after randomization
Treatment success
Patient reaching the completion until it end with infection resolution
Measured: 30 days since randomization
Time to clinical stability
Time required for patient to reach the normalization of all following vital signs: that is, body temperature lower than 37,9 degrees celsius, a cardiac rate lower than 100 beats per minute and a respiratory rate lower than 25 respiratory movements per minute and peripheral oxygen saturation higher than 91% with low oxygen requirement (that is 4 liters per minute delivered by nasal canula)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Sprinz, Principal investigator, Hospita de Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568800
- Sponsor's protocol ID
- 15-0392
- Acronym
- PICNIC
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Infusion Cefepime and Nosocomial Infections
- ClinicalTrials.gov ID
- NCT02568800
- Acronym / sponsor ID
- PICNIC / 15-0392
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 6 Oct 2015 (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.
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
Detailed description
Introduction: it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (T>MIC). Although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit.
Objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes.
Methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. Patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed.
Interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. The randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of SIRS criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Cefepime Infusion | Experimental | Drug: Prolonged Cefepime InfusionCefepime infusions should last 4 hours at least |
| Usual Cefepime Infusion | Active comparator | Drug: Usual Cefepime InfusionCefepime infusion should last no more than 30 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Urinary tract infection after 48-72 hours of hospital stay
- Respiratory tract infection after 48-72 hours of hospital stay
- Catheter related urinary tract infection after 48-72 hours of hospital stay
- Urinary or respiratory infections not responding to a narrower spectrum antibiotic
- Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection
Key exclusion criteria (9 listed)
- Glomerular filtration rate lower than 30 ml.min/1,73m²
- ICU admission for at least 72 hours before randomization
- Neutrophil count lower than 1000 cels per mm³
- Hematologic malignancy, bronchiectasis and cystic fibrosis
- Patients allergic to cefepime
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 |
|---|---|---|
| Prolonged Cefepime InfusionAlso: Estended Cefepime InfusionCefepime infusion should last at least 4 hours with the aide of an infusion bomb | Drug | Prolonged Cefepime Infusion |
| Usual Cefepime InfusionAlso: Regular Cefepime InfusionCefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes | Drug | Usual Cefepime Infusion |
Primary outcome
Death
Time frame: 30 days
Death in 30 days since randomization
7 secondary outcomes
Death
Time frame: 14 days
Duration of hospital stay
Time frame: 30 days since randomization
Intensive care unit (ICU) admission
Time frame: 30 days since randomization
Duration of intensive care unit (ICU) stay
Time frame: 30 days since randomization
Treatment change
Time frame: 3 days after randomization
Treatment success
Time frame: 30 days since randomization
Time to clinical stability
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
Eduardo Sprinz principal investigator
Hospita de Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prolonged Cefepime Infusion and Usual Cefepime Infusion in people with Urinary Tract Infection and Respiratory Tract Infection, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Dias Américo (+555193112207, adamerico@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2015.