Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial
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...
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| Format: | Article |
| Language: | English |
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Elsevier
2019-07-01
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| Series: | EClinicalMedicine |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537019301026 |
| _version_ | 1818700889557303296 |
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| author | Filip Jansåker Sara Thønnings Frederik Boëtius Hertz Thomas Kallemose Jan Værnet Lars Bjerrum Thomas Benfield Niels Frimodt-Møller Jenny Dahl Knudsen |
| author_facet | Filip Jansåker Sara Thønnings Frederik Boëtius Hertz Thomas Kallemose Jan Værnet Lars Bjerrum Thomas Benfield Niels Frimodt-Møller Jenny Dahl Knudsen |
| author_sort | Filip Jansåker |
| collection | DOAJ |
| description | 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: Cystitis, AUC, UTI, Amdinocillin pivoxil, Pivmecillinam, RCT |
| first_indexed | 2024-12-17T15:12:07Z |
| format | Article |
| id | doaj.art-d6b2ea3f934e47c286bd69f2bbdc83a9 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-12-17T15:12:07Z |
| publishDate | 2019-07-01 |
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| series | EClinicalMedicine |
| spelling | doaj.art-d6b2ea3f934e47c286bd69f2bbdc83a92022-12-21T21:43:39ZengElsevierEClinicalMedicine2589-53702019-07-01126269Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trialFilip Jansåker0Sara Thønnings1Frederik Boëtius Hertz2Thomas Kallemose3Jan Værnet4Lars Bjerrum5Thomas Benfield6Niels Frimodt-Møller7Jenny Dahl Knudsen8Department of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark; Analytical BioSciences, Department of Pharmacy, University of Copenhagen, Copenhagen, 2200 Copenhagen, Denmark; Corresponding author at: Department of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark.Department of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark; Analytical BioSciences, Department of Pharmacy, University of Copenhagen, Copenhagen, 2200 Copenhagen, DenmarkDepartment of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, DenmarkClinical Research Centre, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, DenmarkGeneral Practice, AmagerCentrets Læger, Reberbanegade 3, 2300, Copenhagen, DenmarkSection of General Practice and Research Unit of General Practice, Department of Public Health, University of Copenhagen, Oester Farimagsgade 5, 1014, Copenhagen, DenmarkDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark; Department of Infectious Diseases, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, DenmarkDepartment of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark; Department of Clinical Microbiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark; Department of Clinical Microbiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkBackground: 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: Cystitis, AUC, UTI, Amdinocillin pivoxil, Pivmecillinam, RCThttp://www.sciencedirect.com/science/article/pii/S2589537019301026 |
| spellingShingle | Filip Jansåker Sara Thønnings Frederik Boëtius Hertz Thomas Kallemose Jan Værnet Lars Bjerrum Thomas Benfield Niels Frimodt-Møller Jenny Dahl Knudsen Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial EClinicalMedicine |
| title | Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial |
| title_full | Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial |
| title_fullStr | Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial |
| title_full_unstemmed | Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial |
| title_short | Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial |
| title_sort | three versus five days of pivmecillinam for community acquired uncomplicated lower urinary tract infection a randomised double blind placebo controlled superiority trial |
| url | http://www.sciencedirect.com/science/article/pii/S2589537019301026 |
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