PyelonephritisPhase 4MePUrNCT03282006
Treating Pyelonephritis an Urosepsis With Pivmecillinam
A Phase 4 study testing pivmecillinam in people with Pyelonephritis and Urinary Tract Infections, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pyelonephritis, Urinary Tract Infections
- What is being tested?
- pivmecillinam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- 29 Sep 2017to 21 Apr 2020
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- E.coli in blood culture
- AND identical isolate in urine sample (>= 1.000 CFU) OR relevant clinical signs of UTI
Who cannot join
- Bacterial infection origin from another organ (e.g. pneumonia)
- Severe sepsis with multiorgan failure
- Perinephritic abscess
- Pyonephrosis requiring drainage
- Allergy to pivmecillinam
- E.coli isolate resistant to pivmecillinam
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- Pregnancy/breastfeeding
- Severe neutropenia
- Prostatitis
- Severe kidney failure (eGFR<15 ml/min)
- Using valproate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli
Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". The increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant E.coli to quinolones in Norwegian isolates.
Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for treating febrile urinary tract infections is insufficient. This trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by E.coli.
The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.
Read the detailed description
This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational study with intention to treat. Participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day 4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for physical examination. They will report symptom score (standardized schema) on day 0, and 17. Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be stored anonymously. The trial will be monitored by extern resources.
- Conditions
- Pyelonephritis, Urinary Tract Infections
- Being tested
- pivmecillinam
- Keywords
- Pivmecillinam
- Medical subject headings
- Pyelonephritis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pivmecillinamDrug
Also called Selexid, Penomax
Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
| Study group | Role | What they receive |
|---|---|---|
| Pivmecillinam | Experimental | Patients treated with pivmecillinam Receives: Drug: pivmecillinam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (self-reported improvement and EQ 5D VAS-scale).
Measured: Day 17
Secondary outcomes (5)
C-reactive protein-level (CRP)
Compare CRP-level on day 0 with day 17.
Measured: Day 17
Readmission due to urinary tract infection (UTI)
Check if participants are readmitted due to UTI.
Measured: Day 33
Readmission - any cause
Check if participants have been readmitted to hospital
Measured: Day 33
Adverse effects
Registrate frequency of rash/skin problems, abdominal pain, clostridium difficile associated diarrhea
Measured: Day 33
Microbial efficacy
Defined as <1.000 CFU E.coli in urine
Measured: Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start29 Sep 2017
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
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 PyelonephritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Tore Stenstad, Sykehuset i Vestfold HF
- Investigators
- Tore Stenstad, MD, PhD, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282006
- Sponsor's protocol ID
- 2016-000984-18
- Other IDs
- 2016
- Acronym
- MePUr
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2017
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hansen BA, Grude N, Lindbaek M, Stenstad T. The efficacy of pivmecillinam in oral step-down treatment in hospitalised patients with E. coli bacteremic urinary tract infection; a single-arm, uncontrolled treatment study. BMC Infect Dis. 2022 May 19;22(1):478. doi: 10.1186/s12879-022-07463-7.
PubMed 35590284
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli
- ClinicalTrials.gov ID
- NCT03282006
- Acronym / sponsor ID
- MePUr / 2016-000984-18
- Conditions
- Pyelonephritis, Urinary Tract Infections
- Keywords
- Pivmecillinam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". The increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant E.coli to quinolones in Norwegian isolates.
Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for treating febrile urinary tract infections is insufficient. This trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by E.coli.
The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.
Detailed description
This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational study with intention to treat. Participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day 4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for physical examination. They will report symptom score (standardized schema) on day 0, and 17. Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be stored anonymously. The trial will be monitored by extern resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivmecillinam | Experimental | Drug: pivmecillinamPatients treated with pivmecillinam |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- E.coli in blood culture
- AND identical isolate in urine sample (>= 1.000 CFU) OR relevant clinical signs of UTI
Key exclusion criteria (11 listed)
- Bacterial infection origin from another organ (e.g. pneumonia)
- Severe sepsis with multiorgan failure
- Perinephritic abscess
- Pyonephrosis requiring drainage
- Allergy to pivmecillinam
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 |
|---|---|---|
| pivmecillinamAlso: Selexid, PenomaxOral treatment of bacteremic pyelonephritis following standard initial parenteral treatment | Drug | Pivmecillinam |
Primary outcome
Clinical efficacy
Time frame: Day 17
Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (self-reported improvement and EQ 5D VAS-scale).
5 secondary outcomes
C-reactive protein-level (CRP)
Time frame: Day 17
Readmission due to urinary tract infection (UTI)
Time frame: Day 33
Readmission - any cause
Time frame: Day 33
Adverse effects
Time frame: Day 33
Microbial efficacy
Time frame: Day 17
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 22 Apr 2020.
- Derived from this study: PubMed 35590284Hansen BA, Grude N, Lindbaek M, Stenstad T. The efficacy of pivmecillinam in oral step-down treatment in hospitalised patients with E. coli bacteremic urinary tract infection; a single-arm, uncontrolled treatment study. BMC Infect Dis. 2022 May 19;22(1):478. doi: 10.1186/s12879-022-07463-7.
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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.
Tore Stenstad, MD, PhD principal investigator
The Hospital of Vestfold
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pivmecillinam in people with Pyelonephritis and Urinary Tract Infections, run by Sykehuset i Vestfold HF at 1 site in Norway.
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 11 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 22 Apr 2020. 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 Norway. 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?
Clinical efficacy (time frame: Day 17). 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 NCT03282006, 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 22 Apr 2020.