Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections

Håkan Hanberger

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Cefotaxime; Drug: Temocillin

Study type: Interventional

Funder types: Other

Identifiers

NCT02959957

FoHM/UVI 2015

2015-003898-15 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.

Full description

Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria. Temocillin is approved and marketed in a few European countries since the 1980´s but not in Sweden.

The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication.

The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy.

The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:

  • Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency

• Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital)

• Positive urinalysis tests (U-Nitrit and/or U-LPK)

• Have a pre-treatment baseline urinary culture obtained

• Require iv antibacterial treatment of the presumed infection

• Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC

• Signed informed consent

Exclusion criteria

• Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
• Pregnant or nursing women
• Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
• Known chronic renal insufficiency (creatinine clearance < 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
• Known colonization with ESBL
• Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

Temocillin

Experimental group

Description:

Temocillin powder for solution för injection/infusion, per day 6 g (2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.

Treatment:

Drug: Temocillin

Cefotaxime

Active Comparator group

Description:

Cefotaxime powder for solution för injection/infusion, per day 3-6 g (1-2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.

Treatment:

Drug: Cefotaxime