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NCT Number: NCT03282006

Treating Pyelonephritis an Urosepsis With Pivmecillinam

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.

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Key information

Conditions

Pyelonephritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pivmecillinam

Drug

Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment

Other names: Selexid, Penomax

Primary outcomes

  1. 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).

Secondary outcomes

  1. C-reactive protein-level (CRP)

    Time frame: Day 17

    Compare CRP-level on day 0 with day 17.

  2. Readmission due to urinary tract infection (UTI)

    Time frame: Day 33

    Check if participants are readmitted due to UTI.

  3. Readmission - any cause

    Time frame: Day 33

    Check if participants have been readmitted to hospital

  4. Adverse effects

    Time frame: Day 33

    Registrate frequency of rash/skin problems, abdominal pain, clostridium difficile associated diarrhea

  5. Microbial efficacy

    Time frame: Day 17

    Defined as <1.000 CFU E.coli in urine

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Collaborators

  • University of Oslo

Registry information

Official study title

The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli

Acronym: MePUr

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2017
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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