Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) (NCT00520234), a randomized phase 4 study. The primary outcome is Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria..

2. Clinical Question

The registry record describes a randomized, double-blind, placebo-controlled trial in high-risk adults in critical care. Its stated aim was to assess prophylaxis against Candida infection and to examine pre-emptive therapy when infection was identified using a blood test performed twice weekly. The posted primary outcome, however, is the percentage of participants meeting the proven or probable invasive candidiasis definition within 7 days after the end of therapy.

The comparison is between participants assigned to prophylaxis and those assigned to placebo. It concerns the recorded occurrence of the defined endpoint in the modified intent-to-treat population, rather than all participants admitted to intensive care or all participants enrolled. The endpoint combines proven infection, defined using candidemia, Candida culture from a sterile site, or histopathological evidence, with probable infection, defined by consecutive positive beta glucan levels alongside signs and symptoms of infection.

The registry record also lists secondary questions involving mortality, other antifungal use, time to infection, additional fungal infections, beta glucan negativity, response during the pre-emptive phase, and hospital metrics. Results for those outcomes are not reported in the registry record in the registry record described for this analysis. The primary statistical comparison therefore addresses the recorded proportion meeting the combined Candida endpoint, not every stated objective of the trial.

3. Trial Design

The registry record identifies this as a Phase 4, randomized, parallel-group study with quadruple masking. It was placebo controlled and described as double-blind in the official title. The trial enrolled 222 participants. Its recorded status is completed, and the listed start and primary completion dates are 2007-08 and 2010-03.

Participants were assigned to prophylaxis or placebo. The prophylaxis arm received caspofungin 50 mg intravenously daily for up to 28 days of therapy; the placebo arm received normal saline 100 cc intravenously daily. The registry record lists the primary endpoint as proven and probable invasive candidiasis based on modified MSG/EORTC criteria, measured within 7 days after the end of therapy. The analysis population for this endpoint was modified intent-to-treat, defined as participants receiving at least one dose of study drug and without baseline invasive candidiasis.

The primary outcome percentages were 9.8% in the prophylaxis arm, with 102 participants in that outcome analysis, and 16.6% in the placebo arm, with 84 participants. These analysis counts differ from overall enrollment, consistent with the endpoint’s stated population being a defined subset. The registry record does not report the original sample-size justification or the detailed protocol assumptions used to plan enrollment.

The registry record lists 11 outcome measures and 1 analysis. It names outcomes beyond the primary Candida endpoint, including all-cause mortality, initiation of other antifungals, time to proven or probable infection, other invasive fungal infections, beta glucan negativity, response during pre-emptive therapy, and hospital metrics. Ten secondary outcomes are posted, but their numerical results are not reported in the registry record in the registry record. The extent to which the stated pre-emptive-therapy objectives were evaluated in the trial’s results is therefore not established by the posted primary comparison.

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

Analysis population for the primary outcome, as defined in the registry: Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.

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 Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria., measured over Within 7 days after end of therapy.

The primary endpoint is the percentage of participants with proven or probable invasive candidiasis based on modified MSG/EORTC criteria, assessed within 7 days after the end of therapy. Proven disease is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of Candida infection. Probable disease is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.

This is a binary outcome: each participant either meets the endpoint definition or does not. The registry record expresses the result as a percentage of participants. In general, a binary endpoint can make the occurrence of a clinically specified event straightforward to compare between randomized groups. Combining proven and probable cases can capture more than laboratory-confirmed disease alone, but interpretation depends on the operational definitions and assessment window. In this trial, the inclusion of probable cases relies on both repeated beta glucan positivity and clinical signs and symptoms.

The time window matters: the endpoint is not simply any infection at any time, but infection meeting the definition within 7 days after the end of therapy. The analysis applies to the modified intent-to-treat population, excluding participants with baseline invasive candidiasis and requiring at least one dose of study drug. The result should therefore be read as the proportion meeting this specified endpoint in that population and timeframe, rather than as a measure of every infection or every outcome relevant to intensive care.

The registry record lists several secondary outcome topics, but their results are not reported in the registry record in the registry record. Those outcomes cannot be used to extend the primary endpoint finding to mortality, hospital stay, costs, or responses during pre-emptive therapy.

7. Results Posted in the Registry

• Prophylaxis: 9.8% (10/102) versus 16.7% (14/84) on control; risk difference -6.9 percentage points (95% CI -16.7 to 3.0), risk ratio 0.59 (0.28–1.26); unadjusted two-proportion z-test p = 0.165.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary because each participant is classified as meeting or not meeting the definition of proven or probable invasive candidiasis within the specified timeframe. The registry record reports the percentage in each randomized group. For this kind of outcome, a natural summary is the difference between the group risks, commonly called the risk difference. The recalculated estimate is -0.069. Its negative sign indicates that the observed percentage was lower in the prophylaxis group than in the placebo group.

What does an unadjusted comparison mean?

General explanation: an unadjusted comparison uses the posted event counts and denominators to compare the groups directly, without incorporating covariates or strata. It is a transparent summary of the crude group contrast, but it may not match an analysis that accounts for design features or other factors. The recalculation is described as a simple unadjusted re-analysis of the posted summary statistics. It should not be mistaken for the sponsor’s full analysis.

The reported analysis uses the Cochran-Mantel-Haenszel method and gives p=0.14. General explanation: this method can combine comparisons across strata, producing an analysis that accounts for stratification rather than treating all observations as one undivided comparison. The registry record does not specify the strata, adjustments, or additional details of that analysis in the registry record. It is therefore possible to identify the method and reported p-value, but not to reconstruct the sponsor’s complete procedure from the posted details.

How should the p-values be read?

General explanation: a p-value describes how unusual the observed data, or data more extreme, would be under a specified null model. It does not give the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The recalculated unadjusted p-value is 0.165; the registry analysis reports p=0.14. Since these are results from different analytical approaches, the numerical distinction is not evidence by itself of a contradiction. The registry record does not report additional information that would permit a detailed reconciliation.

Neither p-value should be read in isolation. The effect estimate and confidence interval convey direction and precision, while the p-value summarizes a test against a null hypothesis. A p-value above a conventional threshold does not prove no effect, just as a p-value below a threshold would not by itself establish the size or importance of an effect. The original statistical plan and its significance threshold are not reported in the registry record.

What does the confidence interval add?

General explanation: a confidence interval gives a range of values compatible with the data under the method’s assumptions and indicates the uncertainty around an estimate. For the recalculated risk difference, the reported 95% interval includes no difference. It also extends to values on either side of zero, so the posted unadjusted data are compatible with different possible directions of the underlying group contrast. The interval’s breadth reflects limited precision; it does not assign a probability to any one value after the data have been observed.

The risk difference is expressed on the absolute risk scale: it compares percentages directly. Other scales, such as a risk ratio or odds ratio, describe relative contrasts and can present the same data differently. The registry entries contain recalculated values for those scales, but the most direct interpretation is the absolute risk difference because the primary result is reported as percentages. No additional scale is needed to describe the central finding.

General explanation: over-dispersion matters when variation in the data is greater than a model expects. In such settings, standard errors may be too small if the extra variation is ignored, leading to intervals that are too narrow and tests that appear more decisive than warranted. The primary outcome is a binary participant-level measure, and the registry record does not report an over-dispersion assessment or a model for this outcome. There is therefore no basis in the registry record for claiming that over-dispersion was present or that a correction was applied.

What can be said about the analysis plan?

The registry record identifies the primary endpoint, population definition, timeframe, and reported Cochran-Mantel-Haenszel analysis. It does not report the full statistical analysis plan, the original sample-size justification, interim analyses, detailed handling of missing endpoint data, or multiplicity procedures. Those omissions limit assessment of whether the posted analysis exactly followed a prespecified plan. They should be treated as unknowns, rather than filled in by assumptions about standard practice.

The recalculated statistics are a separate, simple unadjusted check using the posted counts and denominators. Because the registry entries mark no discrepancy, no discrepancy warning applies. The distinction between the sponsor’s reported method and the unadjusted recalculation remains important: they answer the comparison through different analytical procedures, and the registry’s own result should be recognized as the reported analysis.

10. Confidence Intervals and Precision

The recalculated risk difference is -0.069, and its 95% confidence interval includes no difference. The interval also permits values in either direction around the no-difference point. This means the point estimate is not precise enough to exclude all plausible contrasts that might reverse direction under the unadjusted analysis. The interval is more informative than the point estimate alone because it displays uncertainty around the observed group difference.

General explanation: a confidence interval is a range produced by a statistical procedure that, under its assumptions, has a stated long-run coverage level. A 95% interval is not a statement that there is a 95% probability the true effect lies in this particular interval. Its interpretation depends on the analysis assumptions and the quality of the underlying data. In this trial, the reported interval pertains to the unadjusted recalculation, not to the registry’s Cochran-Mantel-Haenszel analysis.

The outcome percentages were 9.8% for prophylaxis and 16.6% for placebo, based on 102 and 84 participants, respectively. Those denominators help explain why the group contrast remains uncertain: the analysis includes fewer participants than the total enrollment, and the event counts are limited. This is a description of the posted data, not a claim about the study’s intended precision or its design rationale.

The registry analysis reports p=0.14, while the unadjusted recalculation reports p=0.165. The registry record does not provide a confidence interval for its reported analysis in the registry record, so the precision of that adjusted or stratified result cannot be assessed from the reported p-value alone. The original analysis plan and its intended confidence-interval procedure are not reported in the registry record.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not a record of the trial’s original design calculation. They assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect as the effect to detect. The rows labeled 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect therefore represent different planning targets, not different results from the trial.

The outcome is binary, so these figures are participants per arm, rather than total events. The 80% power column means the illustrated number of participants per arm that would give an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true effect. The 90% power column uses the same idea but targets a 90% chance. These are planning concepts, not guarantees about what a future study would find.

Smaller effects require more participants to detect under the same assumptions. This is why the participant requirements rise as the planning target moves from the full observed effect to a smaller fraction of it. The displayed numbers should be read as scenario-based illustrations; they do not establish that the trial was designed with these assumptions or that its enrollment was adequate for every outcome.

This is not observed power. Observed power calculated from the estimated effect would not resolve the uncertainty in the result; the confidence interval and the underlying sample size are more useful for understanding precision. The trial’s original sample-size justification and design assumptions are not reported in the registry record.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.167; treatment proportion p₁ = 0.098; average p̄ = 0.132.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4792 = 0.9393.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4768 = 0.4013.
4. n = (0.9393 + 0.4013)² / (-0.0686)² = 381.6, rounded up to 382 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.166666666666667                          # control proportion
p1 <- 0.0980392156862745                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(520234)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 382 (80% power), 511 (90% power)
 75% of observed effect: n per arm = 717 (80% power), 959 (90% power)
 50% of observed effect: n per arm = 1,695 (80% power), 2,268 (90% power)
power.prop.test: 381.6 
Simulated power at n = 382 per arm: 0.804 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Analyses Reported by the Sponsor

The registry record’s own analysis is a Cochran-Mantel-Haenszel comparison and reports p=0.14. The simple recalculation from the posted event counts and denominators is unadjusted and gives p=0.165, alongside a risk difference estimate of -0.069 and a 95% confidence interval that includes no difference. These are distinct analyses, so their p-values need not be identical.

The registry record does not provide an effect estimate or confidence interval for its Cochran-Mantel-Haenszel result in the registry record. It also does not specify the strata or other details needed to reproduce that analysis. As a result, the recalculation offers an independent crude comparison of the posted summaries, but it cannot stand in for a full reproduction of the sponsor’s method.

The discrepancy indicator is false. The difference in p-values should be described in light of the methods used, without treating the unadjusted recalculation as a replacement for the registry’s own analysis. The reported sponsor result remains the stated primary analysis; the recalculated estimate is useful as a transparent descriptive check.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists 11 outcome measures, and 10 secondary outcomes are posted. The secondary topics include proven invasive candidiasis, all-cause mortality, initiation of other antifungals, time to proven or probable invasive candidiasis, other invasive fungal infections, beta glucan negativity during the pre-emptive phase, response during pre-emptive therapy, and hospital metrics. Numerical results for those secondary outcomes are not reported in the registry record in the registry record.

General explanation: multiplicity arises when several outcomes, time points, or subgroup comparisons are tested. The more tests conducted, the greater the chance that at least one result appears statistically notable by chance if no adjustment or other strategy is used. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a plan governing how the secondary outcomes were to be interpreted. No claim can therefore be made about whether or how multiplicity was addressed.

The registry record identifies the primary outcome population as modified intent-to-treat: participants who received at least one dose of study drug and did not have invasive candidiasis at baseline. The endpoint analysis contains 102 participants in the prophylaxis arm and 84 in the placebo arm, compared with 222 enrolled overall. The registry record does not report detailed reasons for the difference between overall enrollment and the endpoint analysis counts or the handling of missing endpoint measurements.

General explanation: missing outcome data can affect a treatment comparison if participants with missing measurements differ systematically from those with observed outcomes. The direction and size of such effects depend on why data are missing and on the assumptions used in the analysis. Without information on missingness and its handling, the influence on this endpoint cannot be assessed.

The registry record reports one analysis and names the Cochran-Mantel-Haenszel method, but it does not report the complete statistical analysis plan, interim analyses, or detailed analysis-population rules beyond the endpoint definition. These features are not reported in the registry record. It would be inappropriate to infer that no interim analyses occurred or that a particular missing-data or multiplicity method was used.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: sepsis (6.8%), septic shock (6.0%), cardio-respiratory arrest (3.4%), respiratory failure (3.4%), cardiac arrest (2.9%).

The serious adverse event figures use different group counts from the primary endpoint analysis. The serious-event group lists 33 affected participants among 117 at risk in the prophylaxis group and 28 among 102 at risk in the placebo group. The registry record also lists other adverse events for these groups: 106 affected among 117 at risk with prophylaxis and 87 among 102 at risk with placebo. Death counts are not reported in the registry record.

These are descriptive counts. The figures do not establish that an event was caused by the assigned treatment, and the registry entries do not give event-level timing, severity details beyond the serious-event classification, or statistical comparisons. The serious-event terms listed most often include Sepsis at 6.8%, Septic shock at 6.0%, Cardio-respiratory arrest at 3.4%, Respiratory failure at 3.4%, Cardiac arrest at 2.9%, and Respiratory distress at 2.6%. The registry record does not provide enough detail in the registry record to determine how those term percentages relate to individual participants who may have experienced more than one event.

The adverse event denominators differ from the primary outcome denominators. They should not be substituted for the endpoint analysis population, nor should the adverse event counts be read as comparative risk estimates adjusted for follow-up or other factors. They describe the recorded adverse event summaries, not a causal conclusion.

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

The posted primary results show that 9.8% of participants in the prophylaxis group and 16.6% in the placebo group met the proven or probable invasive candidiasis endpoint within 7 days after therapy ended. The unadjusted risk difference estimate is -0.069. Its 95% confidence interval includes no difference, and the unadjusted p-value is 0.165. The registry’s Cochran-Mantel-Haenszel analysis reports p=0.14.

These results describe a lower observed percentage in the prophylaxis group for this defined endpoint and population. The uncertainty around the unadjusted estimate is substantial enough that the interval includes no difference and values on the other side. The data therefore do not provide a precise estimate of the direction and magnitude of the underlying contrast. A p-value is not a measure of treatment benefit, and the reported values should not be converted into a claim that the groups are identical or definitively different.

The finding applies to the modified intent-to-treat population and the specific endpoint definition and assessment window. It does not directly establish what happened for all 222 enrolled participants, for infections outside the window, or for other outcomes. The registry record lists mortality, antifungal use, additional fungal outcomes, responses during pre-emptive therapy, and hospital metrics, but their results are not reported in the registry record in the registry record.

General explanation: statistical evidence about an outcome is not the same as a complete assessment of clinical value. Interpretation also depends on the outcome’s importance, the precision of the estimate, the quality and completeness of measurement, and evidence across relevant outcomes. The registry entries available for this comparison do not support claims about the unreported secondary outcomes or about the overall balance of benefits and harms. The result is best understood as a registry-reported comparison of one defined Candida endpoint, with uncertainty in the unadjusted effect estimate.

17. Why This Trial Matters Statistically

This trial illustrates how a binary clinical endpoint can be reported through both group percentages and a group contrast. The percentages, 9.8% and 16.6%, are readily understood, while the risk difference estimate of -0.069 expresses the absolute contrast on the risk scale. Considering both helps keep the direction of the observed comparison separate from the uncertainty around it.

It also demonstrates why the analysis method matters. The registry’s Cochran-Mantel-Haenszel test reports p=0.14, whereas the unadjusted recalculation gives p=0.165. These figures arise from different approaches. A methods label and a p-value alone do not supply all the information needed to reproduce an analysis; the registry record does not report the full details of the sponsor’s procedure.

The confidence interval adds a central statistical lesson: an observed difference does not automatically imply a precisely established difference. The recalculated interval includes no difference, leaving a range of compatible contrasts. Interpreting only the point estimate or only a p-value would obscure that uncertainty.

Finally, the trial’s primary analysis population is defined more narrowly than total enrollment, and the registry lists multiple secondary outcomes without reporting their results in the registry record. This underscores the importance of distinguishing enrollment from endpoint denominators and a primary result from a complete assessment of the study’s aims. These are general lessons in reading clinical-trial statistics; they do not resolve the missing details of this registry record.

18. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The primary comparison is based on a defined modified intent-to-treat population rather than all enrolled participants. The endpoint analysis includes 102 participants in the prophylaxis group and 84 in the placebo group, while total enrollment was 222. The registry record does not report the reasons for the difference between enrollment and the analyzed endpoint counts. This limits assessment of how exclusions or unavailable measurements may have affected the result.

The endpoint combines proven and probable invasive candidiasis. The probable definition requires 2 consecutive positive beta glucan levels alongside signs and symptoms of infection, while the proven definition uses candidemia, Candida cultured from a sterile site, or histopathological evidence. The interpretation therefore depends on these criteria and on the specified window within 7 days after therapy. The registry record does not report further information about adjudication or measurement procedures in the registry record.

The sponsor’s reported Cochran-Mantel-Haenszel analysis has a p-value but no reported effect estimate or confidence interval in the registry record. Details about the method’s strata are also not reported in the registry record. This prevents a complete comparison of its estimated effect and precision with the unadjusted recalculation.

The original sample-size justification, full analysis plan, interim analyses, missing-data methods, and multiplicity procedures are not reported in the registry record. The posted planning illustration is based on the observed effect and should not be confused with the trial’s own design assumptions. The registry record lists secondary outcomes, but their numerical results are not reported in the registry record in the registry record. These limitations restrict conclusions to the posted primary comparison and the descriptive adverse event summaries.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) — NCT00520234.
• Registry record last updated 2011-05-09; status last verified 2011-04.
• Results first posted 2011-05-09.
• 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.

22. Record Summary

The registry record describes a completed, randomized, parallel-group Phase 4 trial of caspofungin prophylaxis versus placebo in high-risk adults in critical care. It lists quadruple masking, total enrollment of 222, and a primary endpoint of proven or probable invasive candidiasis within 7 days after therapy.

In the modified intent-to-treat endpoint analysis, the recorded percentages were 9.8% for prophylaxis and 16.6% for placebo. The unadjusted recalculation gives a risk difference estimate of -0.069, with a 95% confidence interval including no difference and p=0.165. The registry’s Cochran-Mantel-Haenszel analysis reports p=0.14.

The registry lists additional clinical and hospital outcomes, but their results are not reported in the registry record in the registry record. The original sample-size justification and several details of the analysis plan are also not reported in the registry record.