Overview

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

Status:
Not yet recruiting
Trial end date:
2027-09-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin or trimethoprim-sulfamethoxazole as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lund University
Treatments:
Amdinocillin Pivoxil
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:

1. Age ≥ 18 years

2. Urine and/or blood culture positive for EPE.

3. In-patient who has received 1-5 days of empiric intravenous antibiotics

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

5. Clinical suspicion of UTI based on at least one of the following symptoms:

1. Dysuria, urinary urgency, difficulty urinating or increased urinary frequency

2. Positive dipstick analysis including positive nitrite or leucocytes ≥ 1

3. Percussion/palpation tenderness over kidneys or bladder tenderness

6. Discontinuing parenteral treatment and starting treatment with per oral antibiotics is
considered safe according to treating physician.

Exclusion Criteria:

1. Known or suspected allergy towards beta-lactams, fluoroquinolones or
trimetoprim-sulfamethoxazole

2. Clinical isolate of EPE is pivmecillinam-resistant, or resistant to both ciprofloxacin
and trimethoprim-sulfamethoxazole, or resistant to ciprofloxacin and the patient has
eGFR below 20 mL/min (i.e. when trimethoprim-sulfamethoxazole is not recommended).

3. Known or suspected pregnancy

4. Aortic aneurysm, myasthenia gravis, long QT-syndrome, severe liver damage, genetic
metabolic diseases associated with severe carnitine deficiency, creatinine clearance <
15 ml/min and/or megaloblastic haematopoiesis.

5. Treatment with Tizanidine (interacts with ciprofloxacin) or dofetilide (interacts with
trimethoprim-sulfamethoxazole).

6. Other reason to which patient is unfit to be included in the study according to
treating physician, e.g. cognitive impairment making the patient unable to leave
informed consent or missing personal identification number complicating follow-up.