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

Table 1 Schedule of procedures

Procedures	Screening	Baseline	Treatment phase						Follow up
Procedures	Screening	Baseline	3 months	6 months	9 months	12 months	At time of UTI	Monthly checks	15 months	18 months
Informed consent		X
Demographics	X	X^a
Medical history		X
Physical examination		X
eGFR and LFTs (a sample for DNA will be taken at one of these time points)	X	X^a	X	X	X	X			X	X
MSU (local laboratory)		X	X	X	X	X	X		X	X
MSU (central laboratory)		X	X	X	X	X	X		X	X
Perineal swab		X		X		X				X
Concomitant medications	X	X^a
Eligibility assessment	X
Randomisation		X
Dispensing of trial drugs		X	X	X	X
Compliance			X	X	X	X	X	X	X	X
UTI record							X
UTI questionnaire			X	X	X	X			X	X
EQ5D-5 L		X	X	X	X	X	X		X	X
Health Resource Use Questionnaire		X	X	X	X	X				X
TQSM						X				X
Adverse event assessments			X	X	X	X	X		X	X
CRF completion	X	X	X	X	X	X	X	X	X	X
Qualitative interviews	X^b					X^c

CRF Case Report Form, DNA deoxyribonucleic acid, eGFR estimated glomerular filtration rate, EQ5D L EuroQoL 5 Dimension Questionnaire, LFT liver function tests, MSU mid-stream urine, TQSM Treatment Questionnaire on Satisfaction with Medication, UTI urinary tract infection
^aScreening data values may be used for baseline if taken within 14 days from date of randomisation. ^b15 patients who declined to participate in main study but consented to interview study. ^c15 patients who do not complete the treatment and 15 patients who stay in the study up to 6 months post randomisation will be interviewed. Time points will vary

ISSN: 1745-6215