Pivmecillinam-Five days course not superior to 3 day course for UTI, finds study

Denmark: A 5-day course of the antibiotic pivmecillinam is not superior to a 3-day course in women with uncomplicated urinary tract infection (UTI) in terms of improvement in clinical or bacteriological outcomes for UTI, finds a recent study in the Lancet journal EClinicalMedicine.

Uncomplicated lower UTI is the most prevalent bacterial infection in women with an incidence of about 10%. If the antimicrobial therapy prescribed for treatment of the condition is inappropriate it causes considerable short-term morbidity and decreased quality of life.

Pivmecillinam (amdinocillin pivoxil) is the oral pro-drug of the antimicrobial active mecillinam (amdinocillin), a unique narrow-spectrum beta-lactam antibiotic that is highly effective against the majority of Enterobacteriaceae, including Escherichia coli -- the most common pathogen to cause UTI.

The current recommendations suggest pivmecillinam for 3 to 7 days for UTI. Also, it suggests a 5- or 7-day course to be superior to a 3-day course. This recommendation, however, is based on findings from a single randomized controlled trial that showed the 7-day course to be superior to a 3-day course in bacteriological effectiveness at day 8–10. A 5-day course and superiority of the 3-day course have never been studied in a controlled trial.

Therefore, Filip Jansåker, Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark, and colleagues investigated if a 5-day course pivmecillinam 400 mg three times daily is superior to a 3-day course in women with uncomplicated UTI.

The participants were randomized to receive blinded therapy of 5 days [5d] or 3 days followed by 2 days of placebo [3d] from May 2015 to November 2017. Clinical data were assessed using a validated questionnaire at inclusion (day-0), daily the following 7 days and once again within the 2nd to 6th week after the intervention. 180 (5d) and 188 (3d) participants were included in the study (mean age: 35.4 [5d] and 34.9 [3d]).

Main clinical endpoints were days to symptom resolution within 7 days after inclusion and proportions with clinical success at the end of the intervention. The main bacteriological endpoint was the proportion of participants with a significant reduction of bacteriuria (≥10² CFU/mL) in the 1st control urine sample. Bacteriological data were collected prior to intervention and twice between day 7 and 42.

Also Read: Study finds combination antibiotic Avycaz, safe and effective for complicated UTIs in children

Key findings include:

• 125 (70% [5d]) and 122 (66% [3d]) had a positive baseline urine culture.


• Forty-four participants were lost to follow-up, leaving 161 [5d] and 163 [3d] participants for analysis, respectively.


• Meantime to symptom resolution was 2.91 days and 2.94 days.


• Clinical success at the end of treatment occurred for 117 of 153 (76%) receiving the 5d-course and for 115 of 157 (73%) receiving the 3d course.


• Bacteriological success was seen in 92 of 104 (88%) participants given the 5d course and in 86 of 99 (87%) given the 3d course.