NCT03282006

Brief 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". 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

April 25, 2017

Last Update Submit

April 21, 2020

Conditions

PyelonephritisUrinary Tract Infections

Keywords

Pivmecillinam

Outcome Measures

Primary Outcomes (1)

  • 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).

    Day 17

Secondary Outcomes (5)

  • C-reactive protein-level (CRP)

    Day 17

  • Readmission due to urinary tract infection (UTI)

    Day 33

  • Readmission - any cause

    Day 33

  • Adverse effects

    Day 33

  • Microbial efficacy

    Day 17

Study Arms (1)

Pivmecillinam

EXPERIMENTAL

Patients treated with pivmecillinam

Drug: pivmecillinam

Interventions

pivmecillinamDRUG

Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment

Also known as: Selexid, Penomax
Pivmecillinam

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • E.coli in blood culture
  • AND identical isolate in urine sample (\>= 1.000 CFU) OR relevant clinical signs of UTI

You may not qualify if:

  • 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
  • Pregnancy/breastfeeding
  • Severe neutropenia
  • Prostatitis
  • Severe kidney failure (eGFR\<15 ml/min)
  • Using valproate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35590284DERIVED

MeSH Terms

Conditions

PyelonephritisUrinary Tract Infections

Interventions

Amdinocillin Pivoxil

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital DiseasesInfections

Intervention Hierarchy (Ancestors)

AmdinocillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tore Stenstad, MD, PhD

    The Hospital of Vestfold

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 25, 2017

First Posted

September 13, 2017

Study Start

September 29, 2017

Primary Completion

April 21, 2020

Study Completion

April 21, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations

NO(1)