Treating Pyelonephritis an Urosepsis With Pivmecillinam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-29

Study Completion Date

2020-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care

NCT07236944

Febrile Urinary Tract Infection

RECRUITING PHASE4

Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs

NCT05224401

Urinary Tract Infections Bacteremia Antibiotic Resistant Infection

RECRUITING PHASE3

Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

NCT00239161

Acute Uncomplicated Pyelonephritis

TERMINATED PHASE4

Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

NCT05545137

Uncomplicated Urinary Tract Infection

COMPLETED PHASE3

Standard Vs Adjusted Dosing of Piperacillin/Tazobactam in Acute Renal Failure and Septic Shock

NCT00816790

Septic Shock Acute Renal Failure

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pyelonephritis Urinary Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pivmecillinam

Patients treated with pivmecillinam

Group Type EXPERIMENTAL

pivmecillinam

Intervention Type DRUG

Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pivmecillinam

Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Selexid, Penomax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No