Treating Pyelonephritis an Urosepsis With Pivmecillinam | NCT03282006

Studies
Treating Pyelonephritis an Urosepsis With Pivmecillinam

NCT03282006

Sponsor

Sykehuset i Vestfold HF

Status

Completed

Last Update Posted

Apr 22, 2020Actual

Enrollment

53Actual

Phase

Phase 4

Conditions

Pyelonephritis
Urinary Tract Infections

Interventions

pivmecillinam

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2017Actual

Primary Completion Date

Apr 21, 2020Actual

Completion Date

Apr 21, 2020Actual

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

Sep 11, 2017

First Posted Date

Sep 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2020

Last Update Posted Date

Apr 22, 2020Actual

Name	Class
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pivmecillinam	Experimental	Patients treated with pivmecillinam	Drug: pivmecillinam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pivmecillinam	Drug	Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment	Pivmecillinam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
C-reactive protein-level (CRP)	Compare CRP-level on day 0 with day 17.	Day 17
Readmission due to urinary tract infection (UTI)	Check if participants are readmitted due to UTI.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tore Stenstad, MD, PhD	The Hospital of Vestfold	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestfold Hospital Trust		Tønsberg	Vestfold	3103	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35590284	Derived	Hansen BA, Grude N, Lindbaek M, Stenstad T. The efficacy of pivmecillinam in oral step-down treatment in hospitalised patients with E. coli bacteremic urinary tract infection; a single-arm, uncontrolled treatment study. BMC Infect Dis. 2022 May 19;22(1):478. doi: 10.1186/s12879-022-07463-7.

Type	Date	Date Unknown
Release	Apr 21, 2023
Reset	Jan 23, 2024

ID	Term
D009395	Nephritis, Interstitial
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D000560	Amdinocillin
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577

ID	Term
D011704	Pyelonephritis
D014552	Urinary Tract Infections