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Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial

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@article{ec7910d725bf407ea72226ad627d27d9,
title = "Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial",
abstract = "Background: To investigate if a 5-day course pivmecillinam (amdinocillin pivoxil) 400 mg three times daily is superior to a 3-day course in women with uncomplicated urinary tract infection (UTI).Methods: A randomised, double-blind, placebo-controlled trial conducted at nine primary care centres in Denmark. 368 women (18-70 years) with symptoms compatible with UTI were randomised to 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 intervention. Bacteriological data were collected prior to intervention and twice between day 7 and 42. Main clinical endpoints were days to symptom resolution within 7 days after inclusion and proportions with clinical success at the end of intervention. Main bacteriological endpoint was proportion of participants with significant reduction of bacteriuria (≥ 102 CFU/mL) in 1st control urine sample. ClinicalTrialsRegister.eu: 2014-001321-32.Findings: 180 (5d) and 188 (3d) participants were included in the study (mean age: 35.4 [5d] and 34.9 [3d]). Of these, 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. Mean time to symptom resolution was 2.91 (SD 1.46; [5d]) days and 2.94 (SD 1.42; [3d]) days (P = .894). 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 (difference 3.2{\%} [95{\%} CI -7.1{\%} - 13.5{\%}]; P = .601). Bacteriological success was seen in 92 of 104 (88{\%}) participants given the 5d course and in 86 of 99 (87{\%}) given the 3d course (difference 1.6{\%} [95{\%} CI -8.4{\%}-11.6{\%}]; P = .895).Interpretations: A 5-day course of pivmecillinam was not superior to a 3-day course in clinical or bacteriological outcomes for UTI.Primary funding source: The Danish Regions [no. 14/217].",
keywords = "Amdinocillin pivoxil, AUC, Cystitis, Pivmecillinam, RCT, UTI",
author = "Filip Jans{\aa}ker and Sara Th{\o}nnings and Hertz, {Frederik Bo{\"e}tius} and Thomas Kallemose and Jan V{\ae}rnet and Lars Bjerrum and Thomas Benfield and Niels Frimodt-M{\o}ller and Knudsen, {Jenny Dahl}",
year = "2019",
month = "7",
doi = "10.1016/j.eclinm.2019.06.009",
language = "English",
volume = "12",
pages = "62--69",
journal = "EClinicalMedicine",
issn = "2589-5370",

}

RIS

TY - JOUR

T1 - Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection

T2 - A randomised, double-blind, placebo-controlled superiority trial

AU - Jansåker, Filip

AU - Thønnings, Sara

AU - Hertz, Frederik Boëtius

AU - Kallemose, Thomas

AU - Værnet, Jan

AU - Bjerrum, Lars

AU - Benfield, Thomas

AU - Frimodt-Møller, Niels

AU - Knudsen, Jenny Dahl

PY - 2019/7

Y1 - 2019/7

N2 - Background: To investigate if a 5-day course pivmecillinam (amdinocillin pivoxil) 400 mg three times daily is superior to a 3-day course in women with uncomplicated urinary tract infection (UTI).Methods: A randomised, double-blind, placebo-controlled trial conducted at nine primary care centres in Denmark. 368 women (18-70 years) with symptoms compatible with UTI were randomised to 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 intervention. Bacteriological data were collected prior to intervention and twice between day 7 and 42. Main clinical endpoints were days to symptom resolution within 7 days after inclusion and proportions with clinical success at the end of intervention. Main bacteriological endpoint was proportion of participants with significant reduction of bacteriuria (≥ 102 CFU/mL) in 1st control urine sample. ClinicalTrialsRegister.eu: 2014-001321-32.Findings: 180 (5d) and 188 (3d) participants were included in the study (mean age: 35.4 [5d] and 34.9 [3d]). Of these, 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. Mean time to symptom resolution was 2.91 (SD 1.46; [5d]) days and 2.94 (SD 1.42; [3d]) days (P = .894). 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 (difference 3.2% [95% CI -7.1% - 13.5%]; P = .601). Bacteriological success was seen in 92 of 104 (88%) participants given the 5d course and in 86 of 99 (87%) given the 3d course (difference 1.6% [95% CI -8.4%-11.6%]; P = .895).Interpretations: A 5-day course of pivmecillinam was not superior to a 3-day course in clinical or bacteriological outcomes for UTI.Primary funding source: The Danish Regions [no. 14/217].

AB - Background: To investigate if a 5-day course pivmecillinam (amdinocillin pivoxil) 400 mg three times daily is superior to a 3-day course in women with uncomplicated urinary tract infection (UTI).Methods: A randomised, double-blind, placebo-controlled trial conducted at nine primary care centres in Denmark. 368 women (18-70 years) with symptoms compatible with UTI were randomised to 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 intervention. Bacteriological data were collected prior to intervention and twice between day 7 and 42. Main clinical endpoints were days to symptom resolution within 7 days after inclusion and proportions with clinical success at the end of intervention. Main bacteriological endpoint was proportion of participants with significant reduction of bacteriuria (≥ 102 CFU/mL) in 1st control urine sample. ClinicalTrialsRegister.eu: 2014-001321-32.Findings: 180 (5d) and 188 (3d) participants were included in the study (mean age: 35.4 [5d] and 34.9 [3d]). Of these, 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. Mean time to symptom resolution was 2.91 (SD 1.46; [5d]) days and 2.94 (SD 1.42; [3d]) days (P = .894). 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 (difference 3.2% [95% CI -7.1% - 13.5%]; P = .601). Bacteriological success was seen in 92 of 104 (88%) participants given the 5d course and in 86 of 99 (87%) given the 3d course (difference 1.6% [95% CI -8.4%-11.6%]; P = .895).Interpretations: A 5-day course of pivmecillinam was not superior to a 3-day course in clinical or bacteriological outcomes for UTI.Primary funding source: The Danish Regions [no. 14/217].

KW - Amdinocillin pivoxil

KW - AUC

KW - Cystitis

KW - Pivmecillinam

KW - RCT

KW - UTI

UR - http://www.scopus.com/inward/record.url?scp=85069569324&partnerID=8YFLogxK

U2 - 10.1016/j.eclinm.2019.06.009

DO - 10.1016/j.eclinm.2019.06.009

M3 - Journal article

VL - 12

SP - 62

EP - 69

JO - EClinicalMedicine

JF - EClinicalMedicine

SN - 2589-5370

ER -

ID: 57728610