Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis (NCT04848688), a randomized phase 3 study. The primary outcome is Cure Rate Against Strongyloides Stercoralis.

2. Clinical Question

The trial record also lists a placebo intervention, but the posted primary comparison is between moxidectin and ivermectin. The available arm descriptions do not specify a placebo comparison. The clinical question is therefore best read as a comparison of the two reported active-treatment groups, rather than as a comparison with placebo.

The outcome is a short-term parasitological measure based on larvae status before and after treatment. The brief summary says stool samples were to be collected before treatment and again 21-28 days after treatment, then analyzed using a quantitative duplicate Baermann assay. That timing differs from the primary outcome timeframe of 14-21 days in the outcome record. The registry record does not explain the difference, so the two descriptions should not be treated as interchangeable.

3. Trial Design

The registry describes a phase 3, randomized, parallel-group trial with quadruple masking. Its official title calls it a randomized controlled non-inferiority trial, while the brief summary describes it as double-blinded. The record does not explain how those masking labels relate to one another or identify which people were masked. Allocation concealment methods and the exact randomization procedure are not reported in the registry record.

The registry reports enrollment of 332 and status as completed. The study is described as an extension to StrongMoxi NCT04056325, with modifications based on the outcome of part A of that study. The start date is 2022-02-05 and the primary completion date is 2022-07-17. The summary identifies Cambodia as the study location, but further site details are not reported in the registry record.

The moxidectin arm description specifies 8 mg orally at day 0; the ivermectin arm description specifies 200 ug/kg orally at day 0. The intervention list also contains entries named Moxidectin 2 mg, Ivermectin 3 mg, and Placebo. The registry record does not explain the relationship between those intervention labels and the arm descriptions, so the arm descriptions are the clearest available statements of the intended treatment regimens for the posted comparison.

The summary describes efficacy, safety, and pharmacokinetic measures as study aims. It says efficacy assessment involved three stool samples before treatment and three samples 21-28 days after treatment, analyzed by a quantitative duplicate Baermann assay. The primary outcome entry, however, gives a 14-21 day timeframe. The registry record does not explain whether these are different assessment descriptions or how the primary outcome timing was determined.

Enrollment, outcome denominators, and safety denominators are not identical as reported: enrollment is 332, the primary outcome groups are 154.0 and 161.0, and the safety groups at risk are 166 each. The registry record does not explain the analysis populations, exclusions, or missing observations that account for these different reported counts. It also does not report the original design assumptions or sample-size justification.

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

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 Cure Rate Against Strongyloides Stercoralis, measured over 14-21 days after treatment.

The primary endpoint is the cure rate against Strongyloides stercoralis, expressed as the percentage of participants who changed from larvae-positive before treatment to larvae-negative after treatment. It is a binary outcome: each participant’s recorded status is classified as meeting or not meeting that definition at the stated follow-up. The registry gives the primary timeframe as 14-21 days after treatment.

This outcome is used to compare the proportion meeting the same prespecified clinical-laboratory definition in each treatment group. A cure rate provides a direct description of the observed results in the analyzed groups, while a between-group contrast describes how far those proportions differ. The record reports group percentages with 95% confidence intervals and a risk-difference comparison. Those summaries address different questions: the group estimates describe each arm, and the risk difference describes the contrast between arms.

The endpoint is based on larvae status, not on a broader claim about long-term outcomes. The record does not report longer-term follow-up for this primary measure. Nor does it give details such as the handling of indeterminate assays or missing post-treatment samples. The brief summary describes stool collection and a quantitative duplicate Baermann assay, but its stated follow-up timing of 21-28 days differs from the primary endpoint timeframe. The registry record does not resolve that discrepancy.

Because the official title describes a non-inferiority trial, interpretation would ordinarily depend on a prespecified margin and an analysis appropriate to that question. The margin, the formal decision criterion, and the primary analysis population are not reported in the registry record. The posted cure rates and risk difference can therefore be described, but they do not by themselves establish whether the trial met its stated non-inferiority objective.

7. Results Posted in the Registry

• Ivermectin: 99.4% (160/161) versus 94.8% (146/154) on control; risk difference 4.6 percentage points (95% CI 0.9 to 8.3), risk ratio 1.05 (1.01–1.09); unadjusted two-proportion z-test p = 0.015.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Ivermectin: 81.0% (81/100) versus 82.0% (91/111) on control; risk difference -1.0 percentage points (95% CI -11.5 to 9.5), risk ratio 0.99 (0.87–1.12); unadjusted two-proportion z-test p = 0.854.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Ivermectin and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes covering larvae reduction rate, cure rates for concomitant Ascaris lumbricoides, Trichuris trichiura, and hookworm infections, and the number of participants reporting adverse events. The detailed numerical secondary comparison available in the record concerns hookworm cure. Numerical results for the other listed secondary outcomes are not reported in the registry record.

The posted hookworm estimates are 82.0% for moxidectin and 81.0% for ivermectin. The risk difference is -0.010, with a 95% confidence interval from -0.115 to 0.095, and the unadjusted p-value is 0.854. The interval spans differences in either direction and is broad relative to the point estimate. This result is therefore much less precise as a comparison than the primary result and does not establish that the groups are equivalent on hookworm cure.

The hookworm result concerns a concomitant infection and a different endpoint population from the primary Strongyloides cure outcome. It does not directly confirm or overturn the primary comparison. The primary result addresses conversion from Strongyloides larvae-positive to larvae-negative; the hookworm result addresses cure for a different infection among the participants contributing to that endpoint.

General: Secondary outcomes can help characterize other measured effects, but they usually carry less confirmatory weight when many outcomes are examined without a reported plan for controlling multiplicity. A collection of unadjusted comparisons increases the chance that at least one result will appear unusual by chance. The registry record does not report a multiplicity adjustment or a hierarchy for secondary analyses. It reports no analyses for the other secondary outcomes, so an overall pattern across all listed secondary endpoints cannot be established from the record.

The record lists eight outcome measures and five posted secondary outcomes, but the registry does not provide the full set of numerical results or analyses. The absence of reported results should not be interpreted as evidence of no effect or no events; it means those results are not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis
• CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides
• CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura
• CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm
• Number of Participants Reporting Adverse Events

9. Statistical Interpretation

10. Statistical Methods Explained

General: A randomized comparison is designed to make treatment groups comparable on average at the start of a study. Random allocation can reduce systematic differences between groups, but it does not guarantee that every characteristic is balanced in a particular trial. The registry identifies the allocation as randomized and the model as parallel. Details of the randomization sequence, allocation concealment, and any stratification are not reported in the registry record.

What does the cure rate describe?

The primary outcome is a binary percentage: it counts participants classified as cured under the stated definition, divided by the participants included in that group’s outcome analysis. Here, the definition is conversion from larvae-positive before treatment to larvae-negative after treatment. The posted group estimates are percentages, and the corresponding outcome denominators are reported separately. The record does not describe how missing or indeterminate test results were treated, so the percentages cannot be independently reconstructed from the registry description alone.

General: A percentage is useful for describing the frequency of an outcome within a group. A comparison between percentages can be reported as a risk difference, which expresses the difference between the groups’ event proportions on the original probability scale. The sign depends on the order in which the groups are subtracted. In this record, the posted comparison is ivermectin against moxidectin, and the positive estimate is consistent with the higher observed cure percentage in the ivermectin group.

How should the confidence intervals be read?

General: A confidence interval gives a range of values compatible with the data and the statistical procedure under its assumptions. It reflects sampling uncertainty in the estimated quantity; it is not a range containing a stated proportion of individual outcomes. The interval for a group cure rate concerns that group’s percentage. The interval for a risk difference concerns the between-group contrast. Those intervals answer distinct questions and should not be conflated.

The registry reports 95% confidence intervals for the cure rates and the risk difference. The primary risk-difference interval runs from 0.009 to 0.083. Its position is consistent with the positive point estimate, but its inferential meaning depends on the analysis method and the trial’s stated non-inferiority criterion. That criterion is not reported in the registry record.

What does the p-value add?

General: A p-value is calculated under a specified null model and summarizes how unusual data at least as incompatible with that model would be if the model were correct. It does not give the probability that the null hypothesis is true, the probability that the result will repeat, or the size of a treatment effect. The registry posts an unadjusted p-value of 0.015 for the primary comparison. The record does not identify the exact test or explain whether the p-value accounts for any other analyses.

Unadjusted means the reported value is not presented as adjusted for multiple comparisons. If several outcomes or comparisons are examined, the chance of obtaining a seemingly notable result somewhere among them can increase. The registry record lists multiple secondary outcomes but does not report a multiplicity procedure. The primary result’s p-value should therefore be interpreted alongside the confidence interval and the missing information about the formal analysis plan.

Why does the non-inferiority label matter?

General: A non-inferiority analysis asks whether the results exclude an unacceptable loss relative to a comparator, using a margin chosen before results are known. It is not equivalent to showing that two treatments have exactly the same effect. The interpretation depends on the margin, the direction of comparison, the confidence interval, and the planned analysis population. In this trial, the official title uses the non-inferiority label, but the margin, formal decision rule, and analysis populations are not reported in the registry record. The observed risk difference therefore cannot be assessed against the intended non-inferiority criterion from the registry information alone.

The record reports 332 enrolled, while the primary outcome denominators are 154.0 and 161.0. It reports safety groups at risk of 166 each. These counts are not interchangeable: an enrollment figure, an outcome analysis denominator, and a safety denominator may refer to different analysis sets. The registry does not explain the differences, so no conclusion about participant flow or exclusions should be inferred from them.

The brief summary describes stool samples collected before treatment and again 21-28 days after treatment. The primary endpoint entry gives a 14-21 day timeframe. Follow-up timing is part of the endpoint definition because it determines when the outcome is assessed. The registry record does not explain the differing timing descriptions, so they should be retained as separately reported details rather than reconciled by assumption.

11. Confidence Intervals and Precision

The primary group estimates are 94.8% for moxidectin and 99.4% for ivermectin. Their 95% confidence intervals are 90.0% to 97.7% and 96.6% to 100.0%, respectively. These intervals communicate uncertainty in each group’s cure-rate estimate. The interval for ivermectin reaches the upper boundary of 100.0%, which is possible for a percentage outcome and signals that the estimate is close to that boundary.

For the direct comparison, the reported risk difference is 0.046, with a 95% confidence interval from 0.009 to 0.083. This interval is the more direct measure of precision for the contrast between the two groups. Its width indicates that the exact size of the difference is uncertain, even though the point estimate has a clear direction. The interval should be interpreted in light of the registry’s non-inferiority title, but the margin required for that interpretation is not reported in the registry record.

General: Greater precision means a narrower interval around an estimate, while less precision means a wider interval. Precision is affected by the amount of information available and by outcome variability. A confidence interval is not a guarantee that the true value falls within the particular reported range; it is a measure produced by a method with stated assumptions. Those assumptions and the exact analysis procedure are not described in sufficient detail in the registry record.

The group confidence intervals overlap, but overlap between separate group intervals is not a formal test of the difference. The risk-difference interval directly addresses the contrast and should be used for that purpose. The record does not report adjusted estimates or additional sensitivity analyses that would show how robust the interval is to different analysis choices.

Precision also depends on which participants contributed outcome data. The primary outcome denominators differ from enrollment and from the safety denominators, and the record does not explain the analysis populations or missing data. As a result, the reported intervals describe the posted estimates, while the record leaves uncertainty about the participant set and procedures underlying those estimates.

12. 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 planning illustrations are based on the observed effect and use equal allocation between the two arms, a two-sided significance level of 0.05, and a normal approximation. Each planning scenario considers detecting a stated fraction of the observed effect. The primary comparison figures are participants per arm, not total participants. The hookworm planning figures are also participants per arm; the registry’s general note about total event counts applies only to time-to-event calculations, and the outcomes are not time-to-event outcomes.

The 80% power column gives the number of participants per arm in the planning illustration for a design with an 80% chance of detecting the specified effect under the stated assumptions. The 90% power column describes the corresponding planning target for a 90% chance. These are prospective planning quantities, not counts observed in this completed trial.

Rows describing 100% of the observed effect use the observed contrast as the planning target; rows describing 75% or 50% use smaller target effects. Smaller effects are harder to distinguish from random variation and therefore require more participants per arm under the same assumptions. This is why the planning quantities increase as the assumed effect becomes smaller. The particularly small observed hookworm contrast produces much larger planning requirements than the primary comparison.

These values are not observed power. They are illustrations calculated from the posted effects and the stated assumptions, rather than the trial’s original design calculation. The original sample-size justification, including any assumptions used when the trial was planned, is not reported in the registry record. The planning illustrations should not be read as evidence that the completed trial had a particular probability of detecting an effect.

13. 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 = 0.948; treatment proportion p₁ = 0.994; average p̄ = 0.971.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.2376 = 0.4657.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.2354 = 0.1981.
4. n = (0.4657 + 0.1981)² / (0.0457)² = 210.7, rounded up to 211 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 <- 0.948051948051948                          # control proportion
p1 <- 0.993788819875776                          # 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(4848688)
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 = 211 (80% power), 282 (90% power)
 75% of observed effect: n per arm = 447 (80% power), 598 (90% power)
 50% of observed effect: n per arm = 1,166 (80% power), 1,560 (90% power)
power.prop.test: 210.7 
Simulated power at n = 211 per arm: 0.859 (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.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary outcome and several secondary outcomes, including larval reduction, cure for concomitant soil-transmitted helminth infections, and adverse events. It reports an unadjusted p-value for the primary comparison and an unadjusted p-value for the posted hookworm comparison. No multiplicity adjustment, testing hierarchy, or distinction between confirmatory and exploratory secondary analyses is reported in the registry record.

General: When multiple outcomes or comparisons are tested, each test creates another opportunity for a result to appear notable by chance. A prespecified testing order or an adjustment procedure can address that issue, but the record does not say whether either was used. Consequently, the p-values should be treated as unadjusted summaries, rather than as proof that the overall family of analyses controlled false-positive risk.

The trial’s official title identifies a non-inferiority objective, but the non-inferiority margin, formal decision rule, and analysis population are not reported. The registry record also does not identify whether the primary result was analyzed in an intention-to-treat population, a per-protocol population, or another set of participants. Those omissions prevent a full assessment of whether the posted estimate was analyzed according to a non-inferiority plan.

Missing-data methods are not reported in the registry record. The record does not state how missing post-treatment stool samples, incomplete assays, or indeterminate results were handled. Nor does it provide a participant-flow account explaining why the primary outcome denominators are 154.0 and 161.0 while enrollment is 332 and safety groups at risk are 166 each. These differences should be noted, but their cause cannot be inferred from the reported counts.

The brief summary describes stool collection 21-28 days after treatment, whereas the primary outcome entry states 14-21 days after treatment. The registry does not explain whether this difference reflects different assessment schedules, a change to the endpoint, or another reason. It also does not report interim analyses, stopping rules, or sensitivity analyses. The absence of these details limits independent evaluation of the analysis strategy; it does not establish that such procedures were or were not used.

15. 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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety results report 0 serious adverse events in the moxidectin group and 0 in the ivermectin group. Each safety group is listed as having 166 participants at risk. The record also reports 0 deaths in each group. These figures describe the safety counts posted in the registry; they do not establish that no less serious events occurred.

For other adverse events, the record reports 15 affected in the moxidectin group and 19 in the ivermectin group, with 166 at risk in each. The registry does not provide event types, severity details, timing, or an analysis comparing these counts. It also does not explain how these safety groups relate to the primary outcome denominators.

General: A count of zero observed serious events is not proof that the underlying risk is zero. The amount of information available and the way events were defined and collected affect what can be concluded. The registry record does not provide enough detail to assess event ascertainment, follow-up completeness, or the statistical precision of safety comparisons. These figures should therefore be read as reported counts, not as a complete characterization of safety.

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

The registry results show a high posted short-term cure proportion in both treatment groups, with the ivermectin estimate higher than the moxidectin estimate. The direct risk-difference estimate is 0.046, and its 95% confidence interval runs from 0.009 to 0.083. The unadjusted p-value is 0.015. These figures describe the observed primary outcome and its statistical uncertainty; they do not by themselves provide a complete interpretation of the trial’s stated non-inferiority objective.

The official title calls the study a non-inferiority trial. To determine whether that objective was met, the result must be evaluated against the non-inferiority margin and formal decision rule. Neither is reported in the registry record. The analysis population and missing-data methods are also not reported, which further limits interpretation of a non-inferiority result. The posted numbers should not be converted into a claim that the treatments were equivalent or that a non-inferiority criterion was satisfied.

The primary endpoint is a short-term laboratory-based outcome defined by larvae status before and after treatment. It does not, by itself, establish longer-term outcomes. The registry summary describes stool sampling 21-28 days after treatment, while the primary outcome entry gives 14-21 days; the record does not resolve this difference. The posted result should be understood in the context of that uncertainty about timing.

The safety counts report no serious adverse events or deaths in either group, alongside other adverse-event counts of 15 and 19. These counts are not a complete safety comparison because the record gives no event descriptions, analysis, or detailed follow-up information. They should not be used to infer that either treatment has no safety risks.

Finally, the available registry results do not answer every question raised by the study aims. The record lists pharmacokinetic measures and several secondary outcomes, but numerical results for most secondary outcomes and pharmacokinetic results are not reported in the registry record. A registry result is a report of the information posted there; it should not be treated as a substitute for the missing analysis details or for outcomes not reported.

17. Why This Trial Matters Statistically

This trial is statistically notable because its official title frames the main comparison as non-inferiority, while the registry record reports a risk difference and confidence interval without the margin needed to interpret that objective. Non-inferiority is not established merely because both groups have high observed cure rates or because a comparison does not show a particular kind of difference. The chosen margin and planned analysis determine what conclusion is supported.

The primary result illustrates why the direct contrast matters. Separate group percentages describe each arm, but the risk difference and its confidence interval describe the comparative question more directly. The interval gives information about the range of contrasts compatible with the analysis, while the unadjusted p-value is a different summary and does not replace the interval or the non-inferiority criterion.

The record also highlights the importance of clearly reported analysis populations. Enrollment is 332, while the primary outcome and safety denominators differ. Without an account of participant flow, missing data, and analysis-set definitions, readers cannot determine how the posted estimates relate to all enrolled participants. This is especially relevant when the trial’s stated objective is non-inferiority.

Finally, the record contains several secondary outcome categories but only one detailed numerical secondary comparison. A single secondary result cannot establish an overall pattern across the listed outcomes, especially when the multiplicity strategy is not reported. Clear reporting of endpoint timing, analysis populations, non-inferiority criteria, and secondary analyses is essential for evaluating what the numerical results support.

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 registry record leaves several trial-specific uncertainties. The most consequential is that the official title identifies a non-inferiority trial, but the non-inferiority margin, formal decision rule, and analysis population are not reported. Without those details, the posted primary contrast cannot be used to determine whether the stated objective was met.

Outcome timing is described differently in two parts of the record. The primary endpoint timeframe is 14-21 days after treatment, while the brief summary describes stool collection 21-28 days after treatment. The record does not explain this difference. The summary also describes three samples before treatment and three after treatment, but the endpoint entry does not provide further detail about how sample results were combined or how incomplete testing was handled.

The participant counts are also incompletely explained. The record reports enrollment of 332, primary outcome denominators of 154.0 and 161.0, and safety groups at risk of 166 each. It does not report a participant-flow account, exclusions, or the reasons for these differing counts. Missing-data methods and the treatment of indeterminate assay results are not reported.

The registry lists a placebo intervention as well as moxidectin and ivermectin intervention labels, but the posted primary comparison and arm descriptions concern moxidectin and ivermectin. The relationship between the intervention labels and the reported arms is not explained. The record also labels masking as quadruple while the summary describes the study as double-blinded, without specifying the masked roles.

Numerical results for most listed secondary outcomes and pharmacokinetic measures are not reported in the registry record. The record does not describe the multiplicity strategy, interim analyses, sensitivity analyses, or the original sample-size justification. These limitations restrict interpretation of the posted results but do not establish what procedures were or were not used.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis — NCT04848688.
• Registry record last updated 2024-01-25; status last verified 2024-01.
• Results first posted 2024-01-24.
• 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 phase 3 parallel-group trial comparing moxidectin and ivermectin in adults with Strongyloides stercoralis infection. It reports enrollment of 332 and identifies the official trial objective as non-inferiority. The summary states that the study was conducted in Cambodia.

The primary outcome is cure, defined as conversion from larvae-positive before treatment to larvae-negative after treatment, with a stated timeframe of 14-21 days. The posted cure rates are 94.8% for moxidectin and 99.4% for ivermectin; the risk difference is 0.046, with a 95% confidence interval from 0.009 to 0.083 and an unadjusted p-value of 0.015.

The registry does not report the non-inferiority margin, analysis populations, or missing-data methods. Its summary’s stool-sampling timeframe differs from the primary outcome timeframe. It reports 0 serious adverse events and 0 deaths in each safety group, but gives limited detail on other adverse events. Numerical results for most listed secondary outcomes are not reported in the registry record.