Treating Pyelonephritis an Urosepsis With Pivmecillinam (MePUr)

Sykehuset i Vestfold HF

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections; Pyelonephritis

Treatments: Drug: pivmecillinam

Study type: Interventional

Funder types: Other

Identifiers

NCT03282006

2016-000984-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Pivmecillinam

Experimental group

Description:

Patients treated with pivmecillinam

Treatment:

Drug: pivmecillinam