Table 1.
Schedule of procedures
| Procedures | Screening | Baseline | Treatment phase | Follow up | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3 months | 6 months | 9 months | 12 months | At time of UTI | Monthly checks | 15 months | 18 months | |||
| Informed consent | X | |||||||||
| Demographics | X | Xa | ||||||||
| Medical history | X | |||||||||
| Physical examination | X | |||||||||
| eGFR and LFTs (a sample for DNA will be taken at one of these time points) | X | Xa | 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 | Xa | ||||||||
| 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 | Xb | Xc | ||||||||
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