UTI trials turn on timing: baseline culture, an end-of-treatment check, a test-of-cure visit and a late follow-up, each with a clinical and a microbiological call. Capture holds the culture results, the symptom diary and the renal dosing data in one study with one audit trail. Build it in the free sandbox, no credit card, and pay only at go-live.
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| Assessment | Screen / D1 | Day 3 | EOT | TOC | LFU |
|---|---|---|---|---|---|
| Baseline urine culture and pathogen | |||||
| Follow-up urine culture | |||||
| Symptom assessment (clinician) | |||||
| Renal function (eGFR / CrCl) | |||||
| Concomitant antibiotics | |||||
| Adverse events |
EOT = end of treatment, TOC = test of cure, LFU = late follow-up
What a UTI trial needs from its EDC
The study data
Complicated UTI (cUTI, including acute pyelonephritis) and uncomplicated UTI (uUTI, mostly cystitis in women) look similar on a protocol synopsis but behave differently as datasets. FDA guidance on cUTI drug development, as widely summarised, accepts a composite response made of symptom resolution without new symptoms and microbiological eradication, often described as the baseline pathogen falling below a defined colony count on urine culture, assessed at a test-of-cure visit with follow-up continuing for a few weeks after therapy starts. Registered cUTI protocols typically assess culture at several visits, including test of cure, and classify the outcome by the guidance rules. Your protocol and statistical analysis plan set the exact thresholds and visit days; the EDC must hold the inputs so they can be applied consistently.
Uncomplicated UTI trials are shorter, outpatient and symptom-led. Women with acute cystitis report dysuria, frequency and urgency, and the endpoint is usually symptom resolution combined with a negative or low-count culture at test of cure. Because participants are at home, a phone diary matters more than it does for hospitalised cUTI patients. Recurrent-UTI prevention studies (vaccines, methenamine, prophylactic antibiotics, D-mannose) flip the structure: the endpoint is the number of culture-confirmed episodes over six to twelve months, so each episode becomes a repeating record with its own culture and treatment.
In both designs the common failure is a mismatch between what the clinic called and what the laboratory reported. A participant is feeling well at test of cure but the culture still grows the baseline organism, or the reverse. Analyses of phase 3 cUTI trials have linked that kind of discordance at test of cure to later clinical failure, which is why you want both fields captured on the same form and a query raised if one is missing at a visit where the protocol requires both.
A single baseline sample can grow more than one organism, and each isolate may carry its own colony count and susceptibility result. A table section on the laboratory form lets the site enter one row per isolate, and each row carries its own audit trail. Keep the reporting laboratory (local or central) in a field so a query about a count can be traced to the source report. For general laboratory structure see laboratory results eCRF and lab data and reference range management.
Culture
Baseline organism
ORGBLColony count at TOC
CFUTOCReporting laboratory
LABSRCAssessment
Clinical response
CLINRSPMicrobiological response
MICRSPRule from the SAP applied in the analysis dataset
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Baseline culture and susceptibility | One or more isolates, count, laboratory source | Laboratory form with a repeating isolate table |
| Symptom assessment | Presence and severity of dysuria, frequency, urgency, flank pain, fever | Site eCRF form each visit, plus a participant diary for uUTI |
| Test-of-cure culture | Count and organism against baseline | Same form, with an edit check that flags a missing culture in the window |
| Renal function and dosing | Serum creatinine, eGFR or creatinine clearance | eGFR CKD-EPI and Cockcroft-Gault calculated read-only from entered values |
| Prior and concomitant antibiotics | Agent, dose, route, dates, reason | Concomitant medications form with a repeating table |
| IV to oral switch, blinding | Double-dummy supply, kit numbers | Randomization and drug supply in the Full Platform plan |
| Adverse events | Onset, severity, relationship, outcome | Adverse event form with SAE sign-off |
Response definitions and thresholds belong to your protocol and statistical plan. Capture holds the source data and applies the checks you configure.
Upload the protocol, let the AI draft visits and forms for you to review, then run practice participants through every window. Free sandbox, no credit card.
Safety and exposure
Antibacterial trials depend on knowing exactly what each participant took. Pre-study antibiotics usually exclude or stratify participants, concomitant antibiotics may make a response non-evaluable, and rescue therapy is by definition a failure. Record every antibacterial with start and stop date and indication in a repeating table, and add an edit check that raises a query when an antibiotic with no stop date overlaps the test-of-cure window. The edit check is a data-management prompt that surfaces the gap; the evaluability decision stays with the study team.
Many UTI agents are cleared by the kidney, so protocols dose by renal function and exclude or adjust severe impairment. Capture can calculate eGFR (CKD-EPI 2021) and creatinine clearance (Cockcroft-Gault) from entered creatinine, age, sex and weight, shown read-only, so the value on the eCRF is the one the pharmacy or investigator used. For the underlying formulas see the eGFR calculator.
Safety signals specific to antibacterial programmes include gastrointestinal events, diarrhoea including Clostridioides difficile infection, hypersensitivity, and infusion-site reactions for intravenous agents. Capture the adverse event form with seriousness and relationship fields, route serious events through the SAE workflow, and grade events with the CTCAE glossary if your protocol uses it. Capture does not code events to a dictionary such as MedDRA; plan coding in your data management process.
Compared with spreadsheets
Build sequence
Upload the protocol (PDF, DOCX or DOC). The AI study builder proposes visits and forms; nothing is saved until a person reviews it.
Set day ranges for end of treatment, test of cure and late follow-up, using the visit-window rules in your protocol.
Isolate table, count, laboratory source, clinical and microbiological response.
Build a daily symptom diary participants complete from a secure phone link, with reminders.
Enter practice participants, include a discordant test of cure, and see the queries fire.
Approved forms lock for live use. You pay only when real participants are enrolled.
Outpatient and recurrent UTI
For uncomplicated and recurrent UTI the participant is the best observer. A daily symptom diary built with the standard question types (single choice, linear scale, numeric, date) opens from a secure link in the phone browser and needs no app. Reminder schedules and completion windows are set per task; see digital patient diary and ePRO compliance reminders. If a symptom score is licensed, the licence stays with your study documents.
Recurrence studies need one record per episode over many months: date of onset, symptoms, culture, antibiotic course. A repeating table section on the episode form keeps every episode in one participant record, so the primary count is a query rather than a spreadsheet reconciliation. Multi-site recruitment is handled with QR-code enrolment, site-level participant numbering and the site coordinator portal; see multi-site clinical trial management. The same platform runs Phase 1 through Phase 3, including registrational antibacterial programmes.
Capture stores the clinical and microbiological calls separately at each visit and applies the edit checks you configure. The composite rule belongs in your statistical analysis plan and is applied on the exported data; SDTM export as SAS XPT with Define-XML is available.
Use a table section on the laboratory form with one row per isolate. Each row carries its own audit trail, so a corrected count shows old value, new value and reason.
Yes. eGFR (CKD-EPI 2021) and creatinine clearance (Cockcroft-Gault) can be calculated from entered values and displayed read-only.
Yes. A diary opens from a secure link on the participant's phone, with reminders and a completion window you control. No app is installed.
No. Capture records and grades events, but dictionary coding should be planned in your data management process.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with multi-site tools and by-site exports.
The sandbox is free with every feature, no credit card and no time limit. You pay only at go-live. See the pricing page for current plans.
Keep exploring
Laboratory results eCRF
Lab form structure to start from.
Concomitant medications eCRF
Antibiotic exposure as a repeating table.
eGFR CKD-EPI calculator
Renal function for dosing.
Adverse event reporting software
Seriousness and sign-off.
EDC for Phase 3 clinical trials
Registrational programmes.
Pricing
Plans for live studies.
Free sandbox with every feature. No credit card, and you pay only when you go live.