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Treating Pyelonephritis an Urosepsis With Pivmecillinam (MePUr)

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ClinicalTrials.gov Identifier: NCT03282006
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Tore Stenstad, Sykehuset i Vestfold HF

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.


Condition or disease Intervention/treatment Phase
Pyelonephritis Urinary Tract Infections Drug: pivmecillinam Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pivmecillinam
Patients treated with pivmecillinam
Drug: pivmecillinam
Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
Other Name: Selexid, Penomax




Primary Outcome Measures :
  1. Clinical efficacy [ Time Frame: Day 17 ]
    Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (EQ 5D).


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282006


Contacts
Contact: Tore Stenstad, MD, PhD +4733342000 tore.stenstad@siv.no
Contact: Bjørn Å Hansen, MD +4733342000 bjornasheim.hansen@siv.no

Locations
Norway
Vestfold Hospital Trust Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Tore Stenstad, PhD    +004733342000    tore.stenstad@siv.no   
Contact: Bjørn Åsheim Hansen, MD    +004733342000    bjornasheim.hansen@siv.no   
Sponsors and Collaborators
Sykehuset i Vestfold HF
University of Oslo
Investigators
Principal Investigator: Tore Stenstad, MD, PhD The Hospital of Vestfold

Responsible Party: Tore Stenstad, MD, PhD, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT03282006     History of Changes
Other Study ID Numbers: 2016-000984-18
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tore Stenstad, Sykehuset i Vestfold HF:
Pivmecillinam

Additional relevant MeSH terms:
Urinary Tract Infections
Pyelonephritis
Infection
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Amdinocillin Pivoxil
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents