This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia (NCT02605122), a randomized phase 2, phase 3 study. The primary outcome is Overview of Adverse Events By Treatment Arm.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02605122 |
| Phase | Phase 2, Phase 3 |
| Condition | Community-acquired Bacterial Pneumonia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 97 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Melinta Therapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Children and adolescents with suspected or confirmed community-acquired bacterial pneumonia were eligible for this study. The registry record does not report the specific age ranges or further eligibility criteria in the registry record for this analysis. The reported primary safety population is described as treatment through Day 28, with the timing stated as 28 days plus or minus 4 days after randomization.
Intervention
The intervention was solithromycin, administered according to age and weight. The registry describes oral capsules or suspension and intravenous treatment; patients could begin with intravenous therapy and switch to an oral formulation. The record does not give the individual dosing schedules in the information.
Comparator
The active comparator was standard of care. The registry lists age-dependent options, including intravenous ceftriaxone, ampicillin, or amoxicillin, and oral amoxicillin or amoxicillin-clavulanic acid. Azithromycin or erythromycin could also be added. The record does not report how many participants received each comparator option.
Primary question
The primary outcome was an overview of adverse events by treatment arm, expressed as participant counts. The registry describes treatment-emergent adverse events through the Day 16 visit and treatment-emergent serious adverse events through the Day 28 visit. The statistical question is therefore about the observed safety-event counts in each arm over these specified windows, not a single clinical-cure contrast. The registry record does not reduce the primary outcome to one comparison across all categories or time points.
3. Trial Design
This was a randomized, parallel-group, active-control study of solithromycin and standard of care for community-acquired bacterial pneumonia in children and adolescents. The registry identifies the study as phase 2/3 and multicenter. It records enrollment of 97 participants and lists the study status as terminated. The start is recorded as 2016-04, and primary completion as 2018-03-21. The reason for termination is not reported in the registry record.
The solithromycin arm allowed oral capsules, oral suspension, or intravenous treatment, with a possible switch from intravenous to oral administration. The regimen was age- and weight-based. Standard of care could involve different antibiotics selected according to age, and the registry lists both intravenous and oral options. This means the comparator was an active-care group rather than placebo, and the record does not identify one single standard-of-care drug used by all participants.
The registry describes the study as open-label, while its masking entry is recorded as single. These descriptions are not reconciled in the registry record, so the extent and operation of masking cannot be determined from the available information. Details such as allocation concealment, the randomization procedure, and whether outcome assessment was masked are not reported in the registry record.
The primary outcome concerns adverse events by treatment arm. The posted results report participant counts for serious events, other events, and deaths. The primary outcome description specifies treatment-emergent adverse events through the Day 16 visit and treatment-emergent serious adverse events through the Day 28 visit. The primary population is described as treatment through Day 28, with the timing stated as 28 days plus or minus 4 days after randomization. Early clinical response, clinical improvement, and clinical cure are listed as secondary outcomes. The registry record does not provide a single primary efficacy comparison in the reported information.
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
| Stage | Solithromycin | Standard of Care |
|---|---|---|
| STARTED | 73 | 24 |
| Received Study Drug | 70 | 24 |
| COMPLETED | 68 | 22 |
| NOT COMPLETED | 5 | 2 |
Reasons for not completing this period:
| Reason | Solithromycin | Standard of Care |
|---|---|---|
| Withdrawal by Subject | 4 | 1 |
| Lost to Follow-up | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Treatment through Day 28 (28 days +/- 4days after randomization)
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.
Population: All subjects who receive at least one dose of study drug (solithromycin or active comparator) were included in the analysis population.
| Characteristic | Unit | Solithromycin | Standard of Care | Total |
|---|---|---|---|---|
| Participants analysed | 70 | 24 | 94 | |
| Age, Categorical: <=18 years | Participants | 70 | 24 | 94 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 9.48 (SD 4.71) | 9.65 (SD 4.95) | 9.57 (SD 4.83) |
| Sex: Female, Male: Female | Participants | 30 | 11 | 41 |
| Sex: Female, Male: Male | Participants | 40 | 13 | 53 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 2 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 65 | 21 | 86 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 12 | 4 | 16 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 11 | 2 | 13 |
| Race (NIH/OMB): White | Participants | 47 | 16 | 63 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: Hungary | participants | 19 | 4 | 23 |
| Region of Enrollment: United States | participants | 18 | 9 | 27 |
| Region of Enrollment: Philippines | participants | 12 | 4 | 16 |
| Region of Enrollment: Bulgaria | participants | 21 | 6 | 27 |
| Region of Enrollment: Spain | participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Overview of Adverse Events By Treatment Arm, measured over Up to 28 days post-treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled an overview of adverse events by treatment arm, with results expressed as counts of participants. It is a safety outcome: it records how many participants experienced events during the specified observation period, rather than measuring symptom change or bacterial response. The description distinguishes treatment-emergent adverse events through the Day 16 visit from treatment-emergent serious adverse events through the Day 28 visit. The overall timeframe is stated as up to 28 days post-treatment, and the population description refers to treatment through Day 28, 28 days plus or minus 4 days after randomization.
In general, safety outcomes are used to characterize events observed while participants receive treatment and during a defined follow-up period. Participant counts give a direct summary of how many people had an event, but a count alone does not describe the event’s duration, intensity, clinical consequences, or the participant’s experience. The registry’s primary outcome description also does not establish whether an event was caused by treatment. Those details are not reported in the registry record.
The results distinguish serious events from other events, and deaths are listed separately. The posted counts should be read within their stated observation windows and alongside the number at risk in each arm. They do not, by themselves, answer a broader question about comparative efficacy or provide a complete account of safety beyond the reported period.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results list 1 participant with a serious adverse event among 70 at risk in the solithromycin arm and 1 among 24 at risk in the standard-of-care arm. The registry also lists 24 participants with other adverse events among 70 at risk for solithromycin and 7 among 24 at risk for standard of care. Deaths are reported as 0 in each arm. These are participant counts, not a complete description of event frequency, severity, timing, or clinical course.
The matching serious-event counts do not imply that the arms had identical safety profiles. The numbers at risk differ, the record does not give a single adjusted comparison, and the event counts are sparse. No uncertainty interval or inferential test for these safety counts is reported in the registry record. It would therefore be inappropriate to treat a simple visual comparison of counts as a precise estimate of a treatment difference. The posted figures describe what was recorded in each arm during the registry’s specified windows.
The registry lists pneumonia viral at 4.2% and pneumonia at 1.4% among the top serious adverse event terms. The record does not assign these term percentages to a particular treatment arm in the information. They should not be read as arm-specific estimates, nor do they substitute for the participant counts in the arm-level results.
There are important limits to the interpretation. The study status is terminated, but the reason is not reported in the registry record. The record reports enrollment of 97 and the safety counts at risk, but does not explain the differences between enrollment and the arm-level risk counts. The exact analysis populations, handling of missing safety observations, and any adjustments are not reported in the registry record. In addition, the study allowed multiple standard-of-care options and more than one route of solithromycin administration, so the arm labels summarize treatment strategies rather than one identical regimen for every participant.
These data support a descriptive reading of the posted events, not a claim that one treatment is safer or less safe. The registry record does not present a single statistical comparison for the primary outcome across its categories or time points. Any planning illustrations based on observed effects are not measures of the trial’s observed power and do not resolve the uncertainty in these safety results.
9. Statistical Methods Explained
What does a participant count represent?
The primary outcome is reported as the number of participants experiencing events. A participant count answers a direct question: how many people in the listed group had an event during the stated observation period? The posted results pair event counts with the number at risk in each arm. They distinguish serious adverse events, other adverse events, and deaths. These categories should be kept separate when interpreting the results, because the registry reports them as distinct summaries.
General statistical explanation: counts are easy to interpret, but they are influenced by the number of people observed. A count without its group size can be misleading when comparing groups of different sizes. Even with group sizes, a count does not tell how often an individual experienced repeated events, how long events lasted, how severe they were, or whether they were judged related to treatment. The registry’s participant-count summaries do not supply those details.
Why do the observation windows matter?
The event summaries use defined follow-up windows. Treatment-emergent adverse events are described through the Day 16 visit, while treatment-emergent serious adverse events are described through the Day 28 visit. The overall timeframe is stated as up to 28 days post-treatment, and the population description refers to treatment through Day 28, 28 days plus or minus 4 days after randomization. A result collected over one window should not be treated as if it covered a longer period. The registry record does not report safety follow-up beyond the described timeframe in the registry record for this analysis.
General statistical explanation: an observation window defines which events can contribute to an outcome. Comparisons can be affected when observation time differs across participants or when missing visits are handled differently. The registry record does not report the methods used to account for incomplete follow-up or differing time under observation.
How should the arm comparison be read?
The primary outcome is an overview with several categories or time points, rather than one reduced comparison. The posted results give counts by arm, but the registry record does not report an inferential test, an adjusted estimate, or a confidence interval for these safety results. A confidence interval, in general, is a way to communicate the precision and uncertainty of an estimated quantity. Without one reported for these comparisons, the precision of a treatment contrast cannot be assessed from the registry results alone.
General statistical explanation: randomization is intended to support fair comparisons by assigning participants to groups through a chance-based process. It does not guarantee that all groups will have matching characteristics, particularly in a study with limited event counts. The registry identifies randomized allocation but does not report the randomization procedure, allocation concealment, or baseline balance in the information. No conclusions about those features should be inferred.
What does the record say about sample-size planning?
The registry record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated fraction of the observed effect is used as the effect to detect in those illustrations. Such calculations are planning aids, not evidence that the completed study had a particular power. They are not observed power and do not change the uncertainty in the trial’s posted results. The actual sample-size justification and the assumptions used in the trial’s original design are not reported in the registry record.
General statistical explanation: a planning calculation estimates the sample size that would be needed under chosen assumptions. It depends on the assumed effect, variability or event rate, significance level, power target, and allocation approach. If the effect used in a planning illustration comes from the observed trial results, it is especially important not to confuse the illustration with an independent confirmation of the result. No planning sample-size values are stated in the registry information.
How do multiple outcomes affect interpretation?
The registry lists four outcome measures and four analyses. It names early clinical response, clinical improvement, and clinical cure as secondary outcomes. The primary outcome itself covers several categories or time points and is not reduced to one comparison. The registry record does not report a statistical analysis plan explaining how results across outcomes, categories, or time points were prioritized or interpreted together.
General statistical explanation: when many outcomes or comparisons are examined, the chance of observing an apparently unusual result can increase if each is assessed separately. Methods for handling multiplicity can be prespecified, but the registry information does not describe such methods. This absence means the reader cannot determine whether any multiplicity adjustment or hierarchy was used; it does not establish that a particular method was or was not used outside the registry record.
The record also does not report the test used for the safety counts, any model specification, covariate adjustment, missing-data approach, or analysis population definitions beyond the primary population description. The results should consequently be treated as descriptive posted summaries, not as an account of a fully documented statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and four analyses. It names early clinical response, clinical improvement, and clinical cure as secondary outcomes, in addition to the primary safety outcome. The primary safety outcome includes several categories or time points and is not reduced in the registry record to a single comparison. The statistical plan for prioritizing outcomes or addressing multiple comparisons is not reported in the registry record.
Missing-data methods are not reported in the registry record. In particular, the record does not describe how participants without a Day 16 or Day 28 assessment were handled, whether event status was carried forward, or whether any sensitivity analyses were conducted. These details matter because incomplete observation can affect participant counts and the interpretation of group summaries. No method should be assumed from the posted counts alone.
The primary population is described as treatment through Day 28, with timing of 28 days plus or minus 4 days after randomization. The record does not provide further definitions of the analysis populations for the primary and secondary outcomes, or explain whether all randomized participants were included in each analysis. It also does not report the handling of protocol deviations or treatment discontinuation. Consequently, the safety figures can be described using the listed at-risk groups, but the broader population rules behind each result are not fully documented in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Solithromycin | 1 | 70 | 1.4% |
| Standard of Care | 1 | 24 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Solithromycin | 0 of 70 |
| Standard of Care | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Solithromycin | 24 of 70 |
| Standard of Care | 7 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Solithromycin | Standard of Care |
|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 70 | 0 of 24 |
| Pneumonia Viral | Infections and infestations | 0 of 70 | 1 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Solithromycin | Standard of Care |
|---|---|---|---|
| Infusion Site Pain | General disorders | 6 of 70 | 0 of 24 |
| Phlebitis | Vascular disorders | 5 of 70 | 0 of 24 |
| Diarrhoea | Gastrointestinal disorders | 1 of 70 | 4 of 24 |
| Alanine Aminotransferase Increased | Investigations | 3 of 70 | 0 of 24 |
| Hepatic Enzyme Increased | Investigations | 1 of 70 | 0 of 24 |
| Oxygen Saturation Decreased | Investigations | 1 of 70 | 0 of 24 |
| Transaminases Increased | Investigations | 1 of 70 | 0 of 24 |
| Bradycardia | Cardiac disorders | 0 of 70 | 1 of 24 |
| Anaemia | Blood and lymphatic system disorders | 1 of 70 | 0 of 24 |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 0 of 70 | 1 of 24 |
Serious events with the highest arm-level rate: pneumonia viral (4.2%), pneumonia (1.4%).
The registry reports 1 participant with a serious adverse event among 70 at risk in the solithromycin arm and 1 among 24 at risk in the standard-of-care arm. It reports 24 participants with other adverse events among 70 at risk for solithromycin and 7 among 24 at risk for standard of care. The death count is 0 in each arm. These summaries refer to participants with events, not to the total number of separate event episodes.
The registry’s top serious adverse event terms are pneumonia viral at 4.2% and pneumonia at 1.4%. The available record does not identify which arm or denominator applies to these term percentages. They should therefore be read only as the listed term summaries, not as arm-specific rates.
General statistical explanation: an adverse event recorded during a study is not necessarily caused by the study treatment. Counts also do not communicate the seriousness of every non-serious event, the timing or duration of events, or how many events an individual experienced. Those details, and the method for judging treatment relatedness, are not reported in the registry record. The figures are a bounded summary of recorded events over the stated follow-up windows, not a complete account of longer-term safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized phase 2/3 study comparing solithromycin with an active standard-of-care group in children and adolescents with community-acquired bacterial pneumonia. Its primary outcome is a safety overview based on participant counts, with adverse events summarized over defined time windows. The posted results show serious adverse event counts of 1 in each arm, other adverse event counts of 24 in the solithromycin arm and 7 in the standard-of-care arm, and no deaths reported in either arm.
These observations describe the participants included in the posted safety summaries. They do not establish that the treatments have the same safety profile, nor do they show that either treatment is safer. The number of events is limited, the arm-level numbers at risk differ, and the registry record does not provide a statistical comparison or uncertainty intervals for these counts. The results also do not establish that an event was caused by a treatment.
The primary outcome does not answer whether solithromycin improved clinical response, clinical improvement, or clinical cure. Those are listed as secondary outcomes, but no results for them are included in the registry record used for this analysis. The registry record also does not explain why the study was terminated, how missing observations were handled, or how multiplicity was addressed. Those omissions limit what can be concluded from the posted information.
General statistical explanation: a trial result is most useful when its estimated effect is considered alongside its precision, design, outcome definitions, and completeness of follow-up. A descriptive count is one component of that evidence, not a definitive verdict. Here, the posted safety summaries can be read as recorded counts over the stated windows, while broader claims about comparative safety or efficacy remain unsupported by the registry information.
13. Why This Trial Matters Statistically
This study illustrates why a registry result needs to be read in context rather than reduced to one number. The primary outcome is a safety overview containing several event categories and time points. The results include participant counts, arm-level numbers at risk, and a separate list of serious adverse event terms. These elements address related but different questions, and the term percentages are not assigned to an arm in the registry information.
The study also used an active comparator with multiple possible standard-of-care antibiotics, while solithromycin could be administered orally or intravenously. This makes the treatment strategies more complex than a comparison between two uniform drug regimens. The registry describes randomization, but the details of treatment distribution, masking, and analysis are not fully reported. The open-label description and the separate single-masking entry are not reconciled.
Statistically, the record is a reminder that participant counts need their observation windows and denominators, and that an equal event count across groups is not itself a formal comparison. The absence of reported uncertainty intervals, missing-data methods, and multiplicity procedures limits the precision of interpretation. The study’s terminated status is also relevant context, although the reason for termination is not reported in the registry record. These features help distinguish what the posted results document from questions they cannot settle.
14. 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 registry record identifies the study as terminated but does not report the reason. It records enrollment of 97, while the safety summaries list 70 at risk in the solithromycin arm and 24 at risk in the standard-of-care arm. The registry information does not explain the relationship between the enrollment figure and those safety populations, so the counts should be interpreted using the arm-specific numbers at risk shown with the results.
The treatment strategies were not necessarily uniform within arms. Solithromycin could be given orally or intravenously, with a possible switch in route, while standard-of-care options varied by age and included several antibiotics. The record does not report how many participants received each option, the extent of treatment switching, or the distribution of these regimens.
The registry describes the study as open-label and separately records masking as single, without reconciling the entries. Further details about masking, randomization procedures, allocation concealment, baseline characteristics, and eligibility criteria are not reported in the registry record. The exact methods for classifying, collecting, and analyzing adverse events are also not fully described in the information.
Follow-up for the primary safety outcome is limited to the described period through Day 28, with treatment-emergent adverse events through Day 16 and serious events through Day 28. Longer-term outcomes are not reported in the registry information used. Missing-data methods, analysis populations beyond the stated primary population, and inferential comparisons are not reported. These limitations make the posted counts useful as descriptive results, while restricting broader conclusions about comparative safety or efficacy.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia — NCT02605122.
- Registry record last updated 2019-01-03; status last verified 2018-11.
- Results first posted 2019-01-03.
- 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.
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18. Record Summary
NCT02605122 is a randomized, parallel, multicenter phase 2/3 study of solithromycin versus standard of care for suspected or confirmed community-acquired bacterial pneumonia in children and adolescents. The registry records enrollment of 97 and a terminated study status. It describes the study as open-label but separately records masking as single; the relationship between those entries is not explained.
The primary outcome is an adverse-event overview by treatment arm, measured as participant counts. Treatment-emergent adverse events are described through the Day 16 visit, and treatment-emergent serious adverse events through the Day 28 visit. The posted results list serious-event counts of 1 in each arm, other-event counts of 24 for solithromycin and 7 for standard of care, and 0 deaths in each arm. The reason for termination, detailed statistical methods, and the handling of missing observations are not reported in the registry record.