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ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): study protocol for a multicentre, pragmatic patient‐randomised non‐inferiority trial

Lookup NU author(s): Rachael Forbes, Dr Alaa Abouhajar, Catherine Brennand, Dr Heather Brown, Dr Sonya Carnell, Dr Thomas Chadwick, Jan Lecouturier, Helen Mossop, Professor Robert Pickard, Christopher Harding

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Abstract

ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women ALTAR Phase IV A multicentre, pragmatic patient-randomised non-inferiority trial comparing two drugs for the prevention of recurrent urinary tract infection in women both during a 12-month period of use and in the subsequent 6-months following completion of the prophylactic medication. Adult females with recurrent uncomplicated urinary tract infection. 240 participants 4 initial sites (with capacity to increase if required) 12 months 6 months 54 Months To determine the relative clinical effectiveness and cost-effectiveness for the NHS of two types of licensed preventative treatments for women with recurrent uncomplicated urinary tract infection (rUTI) over a 12 month treatment period. To determine the relative impact on incidence of symptomatic antibiotic-treated UTI self-reported by patients during the 6 month follow-up period after completion of 12 months of allocated treatment. To determine the total number of days spent on urinary specific antibiotics (prophylactic or treatment) during the 12 month treatment period and 6 months of follow up. To determine if there is any longitudinal ecological change in terms of phenotype and genotype of bacteria and their resistance patterns in isolates from individual participant’s i) urine and ii) faecal reservoir during the 12 month treatment period and in the 6 months following completion of treatment. To determine the number of microbiologically proven urinary tract infections during the 12 month treatment and 6 month follow-up periods. To determine the incidence of asymptomatic bacteriuria (ABU) during the study period. To determine the incidence rate of hospitalisation due to urinary tract infections during the study period. To determine overall patients satisfaction with antibiotic versus antiseptic treatment. To determine patients and clinicians views regarding trial processes and participation via an embedded qualitative study. To determine the Incremental Cost per Quality of Life Year (QALY) gained at 18-month periods based on responses to EQ-5D-5L. To determine the Incremental Costs to the NHS, personal social services measured at the end of the 18-month study period. To determine the relative health economic efficiency over the longer term estimated using a modelling exercise. Incidence of symptomatic antibiotic-treated UTI self-reported by participants and verified where necessary from medical records during the 12 month period of preventative treatment. Incremental cost per quality-adjusted life year (QALY) gained during the 12 month treatment period. Incremental costs to the NHS, personal social services, and the patient at 12 months. The number of symptomatic antibiotic-treated UTI self-reported by participants in the 6 months follow up period after completing the allocated preventative therapy. Total antibiotic use during the study period, reported by patients and verified where necessary from medical records. Phenotype and genotype of Escherichia coli (E. coli) isolated from urine and perineal swabs sent by participants directly to the central reference laboratory. The number of microbiologically confirmed urinary tract infections occurring during both the 12 months of treatment and the subsequent 6 months of follow-up . A positive culture will be classified according to standard Public Health England (PHE) definitions; the laboratory report of two isolates at ≥ 105 cfu/mL or a single isolate at ≥ 104 cfu/mL. Presence of asymptomatic bacteriuria (ABU) identified by urine culture performed at patient visits for study follow-up. ABU is defined as the presence of bacteria in the urine in the absence of symptoms suggestive of urinary tract infection. For the purposes of this study, a positive culture was defined in line with the routine PHE definitions above. The incidence rate of hospitalisation due to urinary tract infections during the treatment and follow-up phases of the study. Overall satisfaction with treatment measured by Treatment Questionnaire on Satisfaction with Medication (TQSM) administered at both the end of treatment (12 months) and then again at the end of follow-up (18 months). Qualitative analysis of patients and clinicians views regarding trial processes and participation. QALYs based on responses to the EQ-5D -5L at 3, 6, 9, 12, 15 and 18 months and after a UTI episode. Treatment costs for drug and healthcare services from a standard NHS source such as British Formulary (BNF) and published tariffs from NHS reference costs. Health resource utilisation questionnaire at 3, 6, 9, 12, 15 and 18 months. Incremental cost per quality-adjusted life year (QALY) gained during the total 18 month trial period. Incremental costs to the NHS, personal social services, and the patient at 18 months. Costs and QALYs will be combined in a cost-utility analysis for both a “within” trial analysis and modelled over the patient’s lifetime using previously developed methods and data from other relevant RCTs that collected patient costs. Experimental: Methenamine hippurate. Control: Nitrofurantoin or Trimethoprim or Cefalexin. Methenamine hippurate 1g oral twice daily. Nitrofurantoin 50mg or 100mg oral once daily. Trimethoprim 100mg oral once daily. Cefalexin 250mg oral once daily.


Publication metadata

Author(s): Forbes R, Ased A, Abouhajar A, Brennand C, Brown H, Carnell S, Chadwick T, Eardley I, Lecouturier J, Mossop H, Pearce I, Pickard R, Thiruchelvam N, Walton K, Wilkinson J, Harding C

Publication type: Article

Publication status: Published

Journal: Trials

Year: 2018

Volume: 19

Online publication date: 09/11/2018

Acceptance date: 17/10/2018

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd

URL: https://doi.org/10.1186/s13063-018-2998-4

DOI: 10.1186/s13063-018-2998-4


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