Treating Pyelonephritis an Urosepsis With Pivmecillinam

Urinary Tract Infections Clinical Trial

— MePUr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282006
• Other study ID #: 2016-000984-18
• Status: Completed
• Phase: Phase 4
• Start date: September 29, 2017
• Est. completion date: April 21, 2020

Study information

• Verified date: April 2020
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• pivmecillinam
Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment

Locations

Country	Name	City	State
Norway	Vestfold Hospital Trust	Tønsberg	Vestfold

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	C-reactive protein-level (CRP)	Compare CRP-level on day 0 with day 17.	Day 17
Secondary	Readmission due to urinary tract infection (UTI)	Check if participants are readmitted due to UTI.	Day 33
Secondary	Readmission - any cause	Check if participants have been readmitted to hospital	Day 33
Secondary	Adverse effects	Registrate frequency of rash/skin problems, abdominal pain, clostridium difficile associated diarrhea	Day 33
Secondary	Microbial efficacy	Defined as <1.000 CFU E.coli in urine	Day 17