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

ConditionsUrinary Tract InfectionsBacteremiaAntibiotic Resistant Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorLund University

About this trial

To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital

Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency

Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and/or bladder.

Disqualifiers

Known or suspected pregnancy.

Known or suspected life-threatening allergy towards beta-lactam antibiotics.

Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem.

Severe renal insufficiency with estimated glomerular filtration rate (eGFR) <10mL/min or requiring any form of dialysis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pivmecillinam and amoxicillin/clavulanic acid

    Drug

    1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin/clavulanic acid 875/125 mg, three times daily.

  • Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility

    Drug

    Ciprofloxacin 500 mg twice daily, trimethoprim/sulfamethoxazole 800 mg/160 mg twice daily or ertapenem 1 g once daily.

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: PAC treatmentExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical cure

Clinical cure defined as being alive with absence of fever (≥ 38.3 C) and resolution of, or return to non-infected baseline of, urinary tract symptoms (as defined in inclusion criteria) without additional antibiotic treatment (for UTI symptoms) based on fever control and a semi-structured interview at a live return visit to an independent physician (i.e. not previously involved in the care of the study participant) at an infectious disease clinic.

Time frame
Clinical cure 10 days (+/- 2 days)

Secondary outcomes

1

To compare the recurrence prevalence of EPE (phenotypically same species) in urine cultures 10 +/- 2 days after antibiotic treatment between groups (i.e., microbiological cure).

Yes or no.

Time frame
Up to 28 days
2

To compare the prevalence of EPE or carbapenemase-producing bacteria in faecal cultures 10 +/- 2 days after antibiotic treatment between groups.

Yes or no.

Time frame
Up to 28 days
3

To compare participants' perception of treatment tolerability

Tolerability is measured on a 1-10 scale.

Time frame
10 days
4

To compare the incidence of early study drug discontinuation between groups.

Yes or no.

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Source ClinicalTrials.gov
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