A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) (NCT06597344), a na phase 3 study. The primary outcome is Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours).

2. Clinical Question

The study asks whether adolescent and adult female participants with uncomplicated urinary tract infection (acute cystitis) achieve clinical symptom improvement during treatment with oral gepotidacin. The primary question focuses on symptom change at 24 hours (±4 hours), rather than a comparison between two treatment groups.

Clinical symptom improvement is defined as a decrease from baseline of at least 1 point in the Clinical Symptom Score (CSS) total, without the need for other systemic antimicrobials. The CSS ranges from 0 to 12, with higher scores indicating greater presence and severity of urinary tract infection symptoms. The endpoint is expressed as the percentage of participants meeting that definition.

The intervention is gepotidacin. The registry record describes a single-arm study and lists no comparator. As a result, its primary question is descriptive: what proportion of the specified analysis population met the symptom-improvement definition at the stated assessment time? It cannot, by itself, answer how that proportion compares with an untreated group or a different treatment.

The registry lists 97 participants as the enrollment and reports 97 at risk in the safety figures. It does not report the observed primary endpoint percentage or its 95% confidence interval. Those results, as well as a numerical estimate of how often symptoms improved, are not reported in the registry record.

3. Trial Design

This is a Phase 3b, open-label, single-arm study of gepotidacin. The registry classifies it as Phase 3, lists allocation as not applicable, and records no masking. The intervention is the drug gepotidacin, and the arm description identifies a single arm. No comparator group is listed.

The study concerns adolescent and adult female participants with uncomplicated urinary tract infections, specifically acute cystitis. Its stated purpose is to evaluate clinical symptom improvement and safety during treatment with oral gepotidacin. The registry lists enrollment of 97. The sponsor is GlaxoSmithKline. The study is recorded as completed, with a start date of 2024-10-02 and a primary completion date of 2025-03-10.

Because the design is single-arm, the primary endpoint describes outcomes among participants receiving gepotidacin. It does not create a concurrent basis for comparing those outcomes against another treatment or against no treatment. The open-label design means masking is not part of the recorded study structure; further details about how symptom assessments were conducted are not reported in the registry record.

The primary outcome is the percentage achieving clinical symptom improvement at 24 hours (±4 hours). Other listed outcomes include clinical symptom improvement and resolution percentages, and counts of treatment-emergent adverse events, serious adverse events, and adverse events of special interest. The registry record does not report numerical results for the primary endpoint or the secondary symptom outcomes. It records selected adverse-event counts, which should be read as descriptive safety information rather than a comparison between treatments.

Although the study is marked completed, that status does not itself supply outcome estimates or explain the analysis methods. Details such as a protocol-based sample-size justification, the statistical analysis plan, and any interim analyses are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Clinically Evaluable (CE) at 24 hours (+4 h) population included all participants in the Intent-to-treat (ITT) population (all participants who enrolled in the study) who adhered to the 2 doses of treatment as prescribed before the 24 hours (±4 hours) CSS assessment (if available), or, before 24 hours (+4 hours) from first dose (if CSS assessment is missing)

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours), measured over At 24 hours (h) (±4 h).

The primary endpoint is the percentage of participants achieving clinical symptom improvement at 24 hours (±4 hours). Improvement is defined as a decrease from baseline of at least 1 point in the CSS total score, without the need for other systemic antimicrobials. The CSS ranges from 0 to 12; higher scores indicate more presence and severity of urinary tract infection symptoms.

This endpoint turns a change in a symptom score into a binary outcome: each participant either meets the stated improvement definition or does not. A percentage can then describe how common that defined response was in the analysis population. The threshold and assessment time make the outcome interpretable in relation to the study’s stated question, though they do not describe every possible aspect of symptom change.

The registry specifies a clinically evaluable population for this assessment. It describes that population as participants in the intent-to-treat population who adhered to the 2 doses of treatment as prescribed before the assessment, if available. The intent-to-treat population is described as all participants who enrolled. The registry’s population description is incomplete, so the full eligibility and assessment rules are not reported in the registry record.

A 95% confidence interval is listed as the endpoint’s dispersion measure. In general, a confidence interval conveys uncertainty around an estimated percentage; its width depends on the estimate and the amount of information available. The registry record does not report the primary endpoint percentage or its confidence interval, so the level and precision of symptom improvement cannot be assessed from the posted endpoint results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a binary percentage endpoint: the percentage of participants who meet a prespecified definition of clinical symptom improvement. The response definition is a decrease from baseline of at least 1 point in CSS total, without the need for other systemic antimicrobials, assessed at 24 hours (±4 hours). The primary endpoint lists a 95% confidence interval as its measure of dispersion. The numerical estimate and interval are not reported in the registry record.

What does a percentage endpoint represent?

In general, a binary endpoint classifies each assessed participant into one of two categories: meeting or not meeting the response definition. The percentage summarizes the frequency of the first category in the analysis population. It is not an average CSS change, and it does not show the distribution of individual score changes. Because the endpoint uses a threshold, two participants with different score changes can both count as responders if each crosses the threshold; a participant with a change just short of the threshold does not meet the stated definition.

The result also depends on who is included in the denominator. The registry describes the clinically evaluable population as drawn from the intent-to-treat population, which it defines as all participants who enrolled, and says participants must have adhered to the 2 doses before the assessment, if available. The complete population definition is not reported in the registry record. Without the endpoint numerator, denominator, and full population rules, the reported percentage cannot be reconstructed or independently checked.

How should a confidence interval be read?

In general, a confidence interval gives a range of values compatible with the observed estimate under the statistical procedure used. A narrower interval indicates greater precision than a wider interval, while neither interval width nor the point estimate alone establishes a causal treatment effect. The interpretation also depends on the analysis population, the handling of unavailable assessments, and the method used to calculate the interval. Those details are not reported in the registry record, and the endpoint’s numerical confidence interval is not reported there either.

A confidence interval is not a guarantee that the true value lies within its particular limits, nor is it a direct measure of clinical importance. It describes sampling uncertainty under the method’s assumptions. For a proportion, the method may matter particularly when the number of responses is small or the estimate is near the limits of the possible range. The registry record does not identify the interval calculation method, so it is not possible to assess those method-specific properties.

Why does the single-arm design constrain inference?

In general, a single-arm study can estimate outcomes within the group observed, but does not provide a contemporaneous control group for estimating a treatment contrast. Changes over time may reflect treatment as well as factors that the design does not distinguish. Open-label status also means the recorded design does not include masking. The registry does not describe further procedures for reducing assessment or reporting influences.

The sample-size assumptions are framed as planning illustrations using a two-sided significance level of 0.05, equal allocation between two hypothetical arms, a normal approximation, and a stated fraction of the observed effect. This framing is not the design used in the registry record, which is single-arm. Such illustrations describe hypothetical planning scenarios and are not observed power. The protocol’s sample-size justification and the numerical planning estimates are not reported in the registry record.

What can the safety counts establish?

In general, adverse-event counts describe events recorded under a defined observation period and case definition. They do not by themselves establish whether an intervention caused an event. The registry lists 0 serious adverse events and 0 deaths among 97 at risk, as well as 23 other adverse events among 97 at risk. Event timing, duration, severity details for the other events, and individual event terms are not reported in the registry record. No comparative safety estimate is available because no comparator arm is listed.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Gepotidacin")
n      <- c(90)
events <- c(49)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Gepotidacin  90  49  54.4  43.6  65.0  44.2  64.3  44.2  64.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and identifies symptom improvement at 24 hours (±4 hours) as the primary outcome. It also lists secondary measures covering clinical symptom improvement, clinical symptom resolution, and counts of treatment-emergent adverse events, serious adverse events, and adverse events of special interest. The record reports no analyses. The statistical analysis plan, any hierarchy among secondary outcomes, and any adjustment for multiple testing are not reported in the registry record.

Multiplicity is a general concern when several outcomes or analyses are examined: the more opportunities there are to identify a notable result, the more important it is to know which analyses were prespecified and how they were interpreted. That does not establish that an error occurred in this study. Rather, without the analysis plan and reported endpoint results, readers cannot determine how multiple outcomes were handled or whether reported analyses followed a prespecified hierarchy.

The registry’s primary population description distinguishes a clinically evaluable population from an intent-to-treat population. It says the latter includes all participants who enrolled, and describes the former as participants who adhered to the 2 doses before the assessment, if available. The description is incomplete. The full analysis population definitions and the number assessed for the primary endpoint are not reported in the registry record.

Missing-data procedures are also not reported in the registry record. It does not state how participants without an available CSS assessment were handled, whether any values were imputed, or what sensitivity analyses were planned. These details matter because the estimated percentage depends on which participants contribute to the denominator and how unavailable assessments are treated. No claim about the amount or impact of missing primary outcome data can be made from the posted information.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 2% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 97 participants at risk for each of the reported safety categories. It records 0 serious adverse events and 0 deaths. For other adverse events, it lists 23 affected. These counts describe the safety information posted for the gepotidacin group; there is no comparator group listed.

A count of zero serious adverse events means none were recorded in that category in the posted figures. It does not establish that serious events are impossible or that the treatment has no serious risks. In general, the interpretation of a safety count depends on the observation period, how events are defined and collected, and the amount of follow-up. Those details are not reported in the registry record.

The record lists no top serious-event terms. With 0 serious adverse events recorded, this absence of terms does not provide an account of the 23 other adverse events. Their specific terms, timing, severity, relationship to treatment, and outcomes are not reported in the registry record. Nor does the record provide a comparative estimate that could show whether event frequencies differ from another treatment.

These counts should therefore be read as descriptive registry data, not as a complete characterization of safety or evidence of causation. The registry lists treatment-emergent adverse events, serious adverse events, and adverse events of special interest among its outcomes, but detailed results for all those categories are not reported in the registry record.

13. What the Result Does, and Does Not, Mean

The posted record establishes that a completed, open-label, single-arm study evaluated gepotidacin in adolescent and adult female participants with uncomplicated urinary tract infection (acute cystitis). It specifies a primary symptom-improvement definition, an assessment time of 24 hours (±4 hours), and a 95% confidence interval as the intended measure of endpoint dispersion. It also reports selected safety counts: 0 serious adverse events, 0 deaths, and 23 other adverse events among 97 at risk.

The record does not report the primary endpoint percentage or its confidence interval. It therefore does not show how often participants met the stated improvement definition or how precisely that proportion was estimated. The listed secondary symptom outcomes also lack numerical results in the registry record. Completion status should not be mistaken for the availability of those estimates.

Even if the primary percentage were reported, a single-arm result would describe outcomes in the treated group rather than establish a comparison with another treatment. The design has no listed comparator, and its open-label structure does not include masking. In general, those design features limit the conclusions that can be drawn about treatment contrasts and the role of other explanations for observed change.

The threshold-based endpoint captures whether a participant crossed a specified CSS change threshold; it does not, by itself, convey the full pattern or size of score changes. The record also does not provide the full analysis-population rules or missing-data approach. Those gaps limit assessment of how the endpoint denominator was determined and how unavailable assessments may have been handled.

The safety figures are similarly descriptive. Counts of zero serious adverse events and zero deaths do not establish absence of risk, while the 23 other adverse events do not establish causation. Event details and comparative safety information are not reported in the registry record. The most defensible reading is therefore limited to the study structure, endpoint definition, and posted counts, without a numerical conclusion about symptom improvement or a comparative treatment effect.

14. Why This Trial Matters Statistically

This study illustrates why a clearly defined endpoint and a reported result are both needed for statistical interpretation. The registry specifies what counts as clinical symptom improvement: a decrease from baseline of at least 1 point in CSS total, without the need for other systemic antimicrobials, at 24 hours (±4 hours). It also specifies that the endpoint is a percentage and identifies a 95% confidence interval as the dispersion measure. Yet the numerical percentage and interval are not reported in the registry record. A precise endpoint definition cannot substitute for the estimate needed to understand its observed frequency and uncertainty.

The study also makes the role of design explicit. In a single-arm, open-label study, outcomes can be described for participants receiving the intervention, but there is no listed concurrent comparator for estimating a treatment contrast. General statistical reasoning distinguishes within-group description from evidence about differences between treatment strategies. The registry’s structure therefore determines the kinds of conclusions its data can support, independently of the endpoint’s clinical framing.

The available safety counts show another interpretive distinction: descriptive frequencies are not the same as causal or comparative assessments. The record lists 0 serious adverse events, 0 deaths, and 23 other adverse events among 97 at risk, but does not report the event details needed for a fuller safety profile.

Finally, the planning assumptions are not the trial design. They describe hypothetical two-arm illustrations with equal allocation and a normal approximation, whereas the registered study has a single arm. Keeping planning calculations separate from observed outcomes and from the actual design prevents a hypothetical sample-size exercise from being mistaken for evidence of statistical power or treatment effect.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting the primary outcome is that its numerical result is not reported in the registry record. Although the endpoint definition and intended confidence interval are described, the percentage and interval are absent. The registry also reports no analyses, so the posted information does not permit review of a primary analysis or its precision.

The single-arm, open-label design has no listed comparator. It can describe outcomes in the group receiving gepotidacin but cannot provide a concurrent treatment contrast. The registry record does not describe additional design or assessment procedures that might clarify how open-label status was addressed.

The analysis-population description is incomplete. It identifies an intent-to-treat population as all enrolled participants and describes a clinically evaluable population in relation to adherence to the 2 doses before assessment, if available, but does not provide the full criteria. The number contributing to the primary endpoint and the approach to missing assessments are not reported in the registry record. These omissions prevent assessment of the endpoint denominator and the possible influence of unavailable data.

Safety reporting is limited to selected counts. The record lists no serious adverse-event terms and does not report details of the 23 other adverse events, such as their timing or specific descriptions. The posted counts also have no comparator for a relative safety assessment.

Finally, the sample-size assumptions describe hypothetical planning illustrations rather than the registered single-arm design. The protocol’s sample-size justification, the statistical analysis plan, any interim analyses, and the numerical planning estimates are not reported in the registry record. These limitations constrain interpretation without establishing that any particular bias or problem occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) — NCT06597344.
• Registry record last updated 2026-02-11; status last verified 2026-01.
• Results first posted 2026-02-11.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry describes NCT06597344 as a completed Phase 3b, open-label, single-arm study of oral gepotidacin in adolescent and adult female participants with uncomplicated urinary tract infection (acute cystitis). It lists GlaxoSmithKline as sponsor, enrollment of 97, a start date of 2024-10-02, and a primary completion date of 2025-03-10.

The primary endpoint is the percentage achieving clinical symptom improvement at 24 hours (±4 hours), defined as a decrease from baseline of at least 1 point in CSS total without the need for other systemic antimicrobials. The endpoint’s 95% confidence interval, the observed primary percentage, and numerical secondary symptom results are not reported in the registry record.

Safety figures list 0 serious adverse events, 0 deaths, and 23 other adverse events among 97 at risk. No comparator is listed, and the registry does not report a statistical analysis plan, complete analysis-population rules, or missing-data methods.