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 IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis (NCT03757234), a randomized phase 2 study. The primary outcome is Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03757234 |
| Phase | Phase 2 |
| Condition | Acute Pyelonephritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 201 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Paratek Pharmaceuticals Inc |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned female adults with acute pyelonephritis, according to the brief summary. Its intent-to-treat population included all randomized participants, whether or not they received study drug. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
Participants were assigned to omadacycline regimens that began with intravenous treatment and continued with intravenous treatment or, in some regimens, oral treatment. The record lists four omadacycline groups: 200 iv/200 iv, 200 iv/100 iv, 200 iv/300 po or 100 iv, and 200 iv/450 po or 100 iv. The registry record does not report a complete description of every dosing instruction in the information.
Comparator
The comparator was levofloxacin 750 iv/750 po or iv. The listed regimen began with intravenous levofloxacin and continued with intravenous or oral levofloxacin. The study therefore included multiple omadacycline regimens and a levofloxacin group; it was not simply a single-dose comparison.
Primary question
The primary endpoint asked whether participants in the intent-to-treat population had an investigator assessment of clinical response at the post-therapy evaluation visit. The assessment classified outcomes as clinical success, clinical failure, or indeterminate. The registry record does not report the group-specific response counts or a statistical comparison for this endpoint, so the treatment groups’ clinical-response results cannot be interpreted from the posted primary endpoint information.
3. Trial Design
This was a randomized, triple-masked, parallel-group phase 2 study. The official title describes it as adaptive, but the specific adaptive features and how they affected allocation or analysis are not reported in the registry record. Enrollment was 201. The study is listed as completed, with a start date of 2018-11-19 and primary completion date of 2019-06-26.
The listed groups comprised four omadacycline regimens and a levofloxacin regimen. Omadacycline treatment began intravenously; some groups continued intravenously, while others could continue orally or intravenously. The levofloxacin regimen also began intravenously and allowed continued oral or intravenous treatment. The registry descriptions identify daily treatment over Days 1 through 7, although some of the arm descriptions are truncated in the registry record. Details beyond those descriptions are not reported in the registry record.
The study’s primary outcome was an investigator assessment of clinical response at the post-therapy evaluation visit in the intent-to-treat population. The visit was scheduled for Day 21, with a stated window of ± 2 days after the participant’s first dose. The investigator classified response as clinical success, clinical failure, or indeterminate. A secondary outcome listed in the record was the number of participants with treatment-emergent adverse events and serious adverse events.
The record does not report the randomization method, allocation concealment, the rationale for the number enrolled, or the detailed statistical analysis plan. The title’s use of “adaptive” does not establish which adaptations were planned or performed; those details are not reported in the registry record. Likewise, the record does not report whether any interim analyses were conducted or how masking was maintained.
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 | Omadacycline 200 iv/200 iv | Omadacycline 200 iv/100 iv | Omadacycline 200 iv/300 po or 100 iv | Omadacycline 200 iv/450 po or 100 iv | Levofloxacin 750 iv/750 po or iv |
|---|---|---|---|---|---|
| STARTED | 75 | 18 | 17 | 17 | 74 |
| Completed PTE Visit | 72 | 16 | 17 | 16 | 71 |
| COMPLETED | 72 | 16 | 17 | 16 | 70 |
| NOT COMPLETED | 3 | 2 | 0 | 1 | 4 |
Reasons for not completing this period:
| Reason | Omadacycline 200 iv/200 iv | Omadacycline 200 iv/100 iv | Omadacycline 200 iv/300 po or 100 iv | Omadacycline 200 iv/450 po or 100 iv | Levofloxacin 750 iv/750 po or iv |
|---|---|---|---|---|---|
| Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Lost to Follow-up | 1 | 0 | 0 | 0 | 1 |
| Withdrawal by Subject | 1 | 1 | 0 | 1 | 2 |
| Other | 1 | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.
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: The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.
| Characteristic | Unit | Omadacycline 200 iv/200 iv | Omadacycline 200 iv/100 iv | Omadacycline 200 iv/300 po or 100 iv | Omadacycline 200 iv/450 po or 100 iv | Levofloxacin 750 iv/750 po or iv | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 75 | 18 | 17 | 17 | 74 | 201 | |
| Age, Continuous | years | 38.2 (SD 14.97) | 33.9 (SD 14.48) | 37.1 (SD 15.97) | 38.2 (SD 17.66) | 38.8 (SD 14.74) | 37.9 (SD 15.07) |
| Sex: Female, Male: Female | Participants | 75 | 18 | 17 | 17 | 74 | 201 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 74 | 18 | 17 | 17 | 74 | 200 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 74 | 18 | 17 | 17 | 74 | 200 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population), measured over Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug)..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the number of participants in the intent-to-treat population with an investigator assessment of clinical response at the post-therapy evaluation visit. The registry record defines clinical success as complete resolution or significant improvement of baseline acute pyelonephritis signs and symptoms such that no additional antimicrobial therapy is required for the current infection. Clinical failure includes lack of apparent response, persistence or reappearance of signs or symptoms requiring additional systemic antimicrobial therapy, or death at or before the visit. If the post-therapy evaluation visit was not completed, the outcome was indeterminate.
This endpoint combines clinical observations with a judgment about whether further antimicrobial therapy is needed. It therefore reflects more than a single symptom or laboratory measurement. General explanation: a clinical endpoint can be useful when the research question concerns how participants fare in terms meaningful to their condition and care, but an investigator-assessed classification also depends on clear definitions and consistent assessment. The registry record gives definitions for the response categories, but does not report procedures for ensuring consistency between investigators.
The assessment was scheduled for Day 21, with a visit window of ± 2 days after the first dose. The registry record does not report the number classified in each response category by group, or an effect estimate and confidence interval for the primary endpoint. As a result, the endpoint’s definition can be described, but its comparative results cannot be assessed from the posted primary outcome information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome information defines the clinical-response measure and its assessment time, but does not give the numbers of participants with success, failure, or indeterminate outcomes by treatment group. It also does not report a group comparison, effect estimate, confidence interval, or p-value for that endpoint. Consequently, the primary clinical-response findings cannot be summarized as a difference between omadacycline and levofloxacin from the registry record.
This absence is important because the primary outcome is categorical, with three possible classifications. A single count of participants assessed would not show how many had clinical success or failure, and the record does not provide the category-specific counts needed to understand the distribution. The registry’s stated reason for not reducing the endpoint to one comparison is that the primary outcome has several categories or time points. The endpoint definition identifies the post-therapy evaluation assessment, but the posted information does not supply the result details needed to resolve that limitation.
Safety information is reported as counts of participants at risk and counts affected in each listed group. Serious adverse events were reported for 2 participants in the Omadacycline 200 iv/300 po or 100 iv group, 2 in the Omadacycline 200 iv/450 po or 100 iv group, and 2 in the Levofloxacin 750 iv/750 po or iv group; none were reported in the other two omadacycline groups. The registry reports 0 deaths in each group. These figures describe the registry’s reported safety counts, not a formal comparison of risks. The record does not provide a comparative safety estimate or uncertainty interval alongside them.
Other adverse events were reported for 21 participants in the Omadacycline 200 iv/200 iv group, 6 in the Omadacycline 200 iv/100 iv group, 7 in the Omadacycline 200 iv/300 po or 100 iv group, 8 in the Omadacycline 200 iv/450 po or 100 iv group, and 16 in the levofloxacin group. These are counts, not adjusted comparisons. They should be read with their group-specific numbers at risk and with the registry’s event definitions and collection procedures in mind; further detail on those procedures is not reported in the registry record.
General explanation: an estimate describes the observed contrast, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. Without a posted primary estimate and its uncertainty, neither the direction nor the precision of a comparative clinical-response result can be evaluated. The reported enrollment and safety counts do not substitute for those missing primary endpoint results.
9. Statistical Methods Explained
The study is described as randomized, triple-masked, and parallel-group. Randomization is intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics, although it does not guarantee identical groups in a particular trial. Masking is intended to limit the influence of treatment knowledge on care, reporting, or assessment. The registry record does not report the randomization procedure, allocation concealment, or details of how masking was implemented. It also does not explain what “triple” refers to in this study.
The title identifies the trial as adaptive. General explanation: an adaptive trial may use prespecified rules to change aspects of its conduct in response to accumulating information. Such rules need to be understood because adaptation can affect how estimates and uncertainty are interpreted. The particular adaptations, decision rules, and any changes actually made are not reported in the registry record. The label alone is not enough to infer how the trial was conducted or analyzed.
The primary endpoint is a categorical investigator assessment with clinical success, clinical failure, and indeterminate outcomes. General explanation: for a categorical endpoint, analysts can describe counts and proportions in each category, then use a comparison method appropriate to the outcome and design. The choice depends on the planned estimand, handling of missing assessments, group structure, and any adjustment or stratification. The registry record does not report the specific statistical method for the primary comparison, an estimand, or a confidence interval. No primary group counts are reported in the available outcome information.
The endpoint’s intent-to-treat population includes all randomized participants regardless of whether they received study drug. General explanation: an intent-to-treat analysis generally preserves the comparison created by randomization and reflects assignment to treatment rather than only treatment received. The registry’s definition establishes who belongs to this population, but it does not specify how participants with missing post-therapy assessments were handled in the analysis. The endpoint definition labels an incomplete visit as indeterminate; whether this classification was used in the analysis and how it was incorporated are not reported in the registry record.
The registry lists a secondary outcome concerning participants with treatment-emergent adverse events and serious adverse events. Safety counts are shown by treatment group, including the numbers at risk and affected. General explanation: counts provide a direct description of how many participants were reported with events, while a comparative safety analysis would also need a defined analysis population, event window, and suitable uncertainty estimates. The registry record does not report a comparative safety model or confidence intervals for these counts.
The sample-size assumptions described in the record are for a planning illustration computed from the observed effect, not the trial’s own design. The stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. The record also distinguishes participant-per-arm planning for outcomes other than time-to-event outcomes. These assumptions should not be read as the original justification for enrollment. They are planning illustrations, not observed power. The registry record does not report the trial’s sample-size justification or its original target by group.
General explanation: a significance level is a threshold used in a testing procedure, not the probability that a result is true. A confidence interval communicates statistical uncertainty around an estimate and can show whether the data are compatible with a range of effect sizes. Neither can be interpreted for the primary clinical-response comparison without the posted effect estimate and its uncertainty. A p-value alone, if one were available, would not establish clinical importance or resolve concerns about missing data, endpoint definitions, or multiple comparisons.
For count outcomes, general statistical methods may use models that account for the outcome’s distribution and the structure of the comparison. Over-dispersion matters in settings where the observed variability exceeds the assumptions of a simple model, because an unaccounted-for excess can make uncertainty appear too small. The registry record does not report a model for the primary endpoint or provide information indicating whether over-dispersion was assessed. No model choice should therefore be inferred from the endpoint description alone.
When a registry lists multiple groups, endpoints, categories, or analyses, interpretation also depends on which comparisons were prespecified and how multiplicity was addressed. General explanation: repeated testing can increase the chance of at least one apparently notable result when many hypotheses are examined. A prespecified testing hierarchy or other adjustment can help define how evidence is evaluated. The registry record does not report a multiplicity strategy, a primary contrast among the listed regimens, or the detailed analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint has three possible classifications: clinical success, clinical failure, and indeterminate. The registry indicates that this outcome has several categories or time points and was not reduced to one comparison. The record does not report category-specific results by group, a primary contrast among the four omadacycline regimens and levofloxacin, or how multiple comparisons were handled. A multiplicity plan is not reported in the registry record.
The intent-to-treat population is defined as all randomized participants, regardless of whether they received study drug. This specifies the population membership, but not the analysis method for missing outcome information. The endpoint definition classifies a participant as indeterminate when the post-therapy evaluation visit was not completed. The registry record does not report how many visits were incomplete, whether indeterminate outcomes were analyzed as a separate category, or whether any other missing-data methods were used.
General explanation: missing outcome information can affect interpretation when the likelihood of missingness differs between groups or relates to participants’ outcomes. An analysis that treats missing outcomes as a distinct category answers a different question from one that imputes an outcome or excludes missing observations. Without reported counts and methods, the extent and potential influence of missing primary endpoint data cannot be evaluated.
The record does not report interim analyses, stopping rules, or the specific adaptive procedures, despite describing the study as adaptive. Nor does it report whether any analysis populations beyond the intent-to-treat population were used for the primary endpoint. These details are needed to assess how the analysis addressed repeated looks at the data, participant exclusions, and multiple possible comparisons.
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 |
|---|---|---|---|
| Omadacycline 200 iv/200 iv | 0 | 75 | 0.0% |
| Omadacycline 200 iv/100 iv | 0 | 18 | 0.0% |
| Omadacycline 200 iv/300 po or 100 iv | 2 | 17 | 11.8% |
| Omadacycline 200 iv/450 po or 100 iv | 2 | 17 | 11.8% |
| Levofloxacin 750 iv/750 po or iv | 2 | 74 | 2.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Omadacycline 200 iv/200 iv | 0 of 75 |
| Omadacycline 200 iv/100 iv | 0 of 18 |
| Omadacycline 200 iv/300 po or 100 iv | 0 of 17 |
| Omadacycline 200 iv/450 po or 100 iv | 0 of 17 |
| Levofloxacin 750 iv/750 po or iv | 0 of 74 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Omadacycline 200 iv/200 iv | 21 of 75 |
| Omadacycline 200 iv/100 iv | 6 of 18 |
| Omadacycline 200 iv/300 po or 100 iv | 7 of 17 |
| Omadacycline 200 iv/450 po or 100 iv | 8 of 17 |
| Levofloxacin 750 iv/750 po or iv | 16 of 74 |
Most frequent serious adverse event terms
| Event term | Organ system | Omadacycline 200 iv/200 iv | Omadacycline 200 iv/100 iv | Omadacycline 200 iv/300 po or 100 iv | Omadacycline 200 iv/450 po or 100 iv | Levofloxacin 750 iv/750 po or iv |
|---|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 75 | 0 of 18 | 0 of 17 | 1 of 17 | 1 of 74 |
| Renal abscess | Infections and infestations | 0 of 75 | 0 of 18 | 1 of 17 | 0 of 17 | 0 of 74 |
| Pyelonephritis acute | Infections and infestations | 0 of 75 | 0 of 18 | 1 of 17 | 0 of 17 | 0 of 74 |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | 0 of 75 | 0 of 18 | 0 of 17 | 1 of 17 | 0 of 74 |
| Escherichia bacteraemia | Infections and infestations | 0 of 75 | 0 of 18 | 0 of 17 | 1 of 17 | 0 of 74 |
| Anaemia | Blood and lymphatic system disorders | 0 of 75 | 0 of 18 | 0 of 17 | 0 of 17 | 1 of 74 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Omadacycline 200 iv/200 iv | Omadacycline 200 iv/100 iv | Omadacycline 200 iv/300 po or 100 iv | Omadacycline 200 iv/450 po or 100 iv | Levofloxacin 750 iv/750 po or iv |
|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 8 of 75 | 0 of 18 | 2 of 17 | 3 of 17 | 5 of 74 |
| Nausea | Gastrointestinal disorders | 3 of 75 | 0 of 18 | 0 of 17 | 4 of 17 | 5 of 74 |
| Asymptomatic bacteriuria | Infections and infestations | 3 of 75 | 2 of 18 | 2 of 17 | 1 of 17 | 1 of 74 |
| Diarrhoea | Gastrointestinal disorders | 1 of 75 | 1 of 18 | 0 of 17 | 1 of 17 | 5 of 74 |
| Asthenia | General disorders | 2 of 75 | 0 of 18 | 0 of 17 | 0 of 17 | 1 of 74 |
| Dizziness | Nervous system disorders | 3 of 75 | 0 of 18 | 0 of 17 | 0 of 17 | 0 of 74 |
| Rash erythematous | Skin and subcutaneous tissue disorders | 3 of 75 | 0 of 18 | 0 of 17 | 0 of 17 | 0 of 74 |
| Vomiting | Gastrointestinal disorders | 0 of 75 | 0 of 18 | 0 of 17 | 1 of 17 | 1 of 74 |
| Alanine aminotransferase increased | Investigations | 1 of 75 | 1 of 18 | 0 of 17 | 0 of 17 | 0 of 74 |
| Body temperature increased | Investigations | 0 of 75 | 0 of 18 | 0 of 17 | 1 of 17 | 1 of 74 |
Serious events with the highest arm-level rate: renal abscess (5.9%), pyelonephritis acute (5.9%), duodenal ulcer haemorrhage (5.9%), pneumonia (5.9%), escherichia bacteraemia (5.9%).
The registry reports serious adverse event counts alongside the number at risk in each group. Serious events affected 0 of 75 participants in the Omadacycline 200 iv/200 iv group, 0 of 18 in the Omadacycline 200 iv/100 iv group, 2 of 17 in the Omadacycline 200 iv/300 po or 100 iv group, 2 of 17 in the Omadacycline 200 iv/450 po or 100 iv group, and 2 of 74 in the levofloxacin group. The record reports 0 deaths in each group.
Other adverse events affected 21 of 75, 6 of 18, 7 of 17, 8 of 17, and 16 of 74 participants in the listed groups, respectively. These counts describe participants reported as affected; they do not indicate the total number of events if a participant experienced more than one event. The registry record does not report details needed to determine that distinction or the methods used for comparative safety analysis.
The listed serious-event terms include Renal abscess, Pyelonephritis acute, Duodenal ulcer haemorrhage, Pneumonia, and Escherichia bacteraemia, each reported as 5.9%, and Anaemia, reported as 1.4%. These percentages are registry entries; the record does not give further context for their denominators in the information. Safety counts are descriptive and do not by themselves establish a difference between groups.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized phase 2 comparison involving four omadacycline regimens and a levofloxacin regimen for female adults with acute pyelonephritis. It defines the primary clinical-response endpoint and reports safety counts by group. Those features allow readers to understand the intended clinical question and the kinds of outcomes recorded.
The posted information does not include the primary endpoint’s response counts by group or a comparative estimate with uncertainty. It therefore does not establish which group had more clinical successes, whether any observed contrast was precise, or whether differences were compatible with a range of clinically relevant effects. Without those results, the primary clinical-response findings cannot be interpreted from the registry record.
The safety information shows reported counts of participants with serious and other adverse events and reports no deaths in the listed groups. These counts are not a randomized comparative safety analysis on their own. They do not account for uncertainty, establish causation, or show whether event patterns differ reliably between regimens. The record’s event-term percentages also do not replace a complete account of definitions, timing, and analysis.
General explanation: a trial’s design and endpoint definitions describe how a question was intended to be studied; results are needed to determine what the observed data say. Statistical uncertainty is essential because an estimate based on trial data is not a perfectly precise description of an underlying treatment contrast. Clinical importance also requires interpretation of the endpoint and the magnitude and precision of any reported effect. Those considerations cannot be completed without the missing primary results.
The sample-size assumptions in the record are planning illustrations based on an observed effect, not the trial’s own design justification and not observed power. They cannot be used to infer the trial’s ability to detect a clinically meaningful difference. The registry record does not report the original sample-size justification, detailed statistical plan, or primary comparative results.
13. Why This Trial Matters Statistically
This study is statistically notable for combining several omadacycline regimens with a levofloxacin comparator in a randomized, parallel-group phase 2 design. That structure raises questions about which regimen-to-comparator contrasts were intended to guide interpretation and how those contrasts were handled analytically. The registry record does not report the planned comparison hierarchy or multiplicity strategy, so the intended inferential structure cannot be established from the posted details.
The primary endpoint is an investigator-assessed categorical outcome, and the record defines success, failure, and indeterminate classifications. Those definitions matter because they determine what counts as an outcome and how an incomplete post-therapy evaluation is represented. The visit’s timing is specified, but the primary group results and analysis method are not reported in the registry record. A clear endpoint definition without corresponding results is not enough to assess the treatment comparison.
The record also labels the study adaptive. General explanation: adaptation can change a trial’s conduct in ways that affect estimation and statistical error rates, so decision rules and their implementation are important for interpreting results. The registry record does not report the specific adaptations or whether interim analyses occurred. The label alone cannot answer those questions.
Finally, the record distinguishes planning illustrations from the trial’s design and reports safety counts without a comparative estimate. This is a useful reminder that planning calculations, observed outcomes, and inferential comparisons serve different purposes. The available information supports a description of the design and selected safety counts, but not a conclusion about comparative clinical-response effects.
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 main limitation for interpreting this trial from the registry record is that the primary endpoint results are not reported by group. The record describes clinical success, failure, and indeterminate outcomes, but does not give the counts in those categories or a comparative estimate and its uncertainty. The reason listed for not reducing the outcome to one comparison is its several categories or time points.
The study is described as adaptive, but the specific adaptation rules, implementation, and any interim analyses are not reported in the registry record. The record also does not provide the randomization procedure, allocation concealment details, or the method used to maintain masking. These omissions prevent a more detailed assessment of design and analysis choices.
The intent-to-treat population is defined, and an incomplete post-therapy evaluation is classified as indeterminate in the endpoint definition. However, the number of incomplete visits and the analysis method for those outcomes are not reported. The record does not explain whether additional analysis populations or missing-data approaches were used.
Safety counts are available, but comparative estimates, uncertainty intervals, and detailed event-collection methods are not reported. The registry’s list of serious-event terms includes percentages, but the relevant denominator details are not specified in the information. Some arm descriptions are truncated, limiting the amount of dosing detail that can be summarized. The sample-size assumptions are identified as planning illustrations, not the trial’s own design justification; the original sample-size rationale is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis — NCT03757234.
- Registry record last updated 2020-07-07; status last verified 2020-07.
- Results first posted 2020-07-07.
- 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
NCT03757234 is a completed randomized, triple-masked, parallel-group phase 2 study of intravenous or intravenous/oral omadacycline regimens and intravenous/oral levofloxacin for female adults with acute pyelonephritis. Enrollment was 201. The study started on 2018-11-19 and reached primary completion on 2019-06-26. Its official title describes it as adaptive.
The primary endpoint was investigator-assessed clinical response at the post-therapy evaluation visit in the intent-to-treat population, scheduled for Day 21 ± 2 days after the first dose. The registry defines clinical success, clinical failure, and indeterminate outcomes but does not report group-specific primary endpoint results. Safety counts, including serious adverse events and deaths, are reported by group. The detailed statistical plan, missing-data methods, multiplicity approach, adaptive procedures, and original sample-size justification are not reported in the registry record.