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 Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design (NCT01785186), a randomized phase 2 study. The primary outcome is Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01785186 |
| Phase | Phase 2 |
| Condition | Tuberculosis, Pulmonary |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 365 |
| Arms in the primary outcome | 5 |
| Lead sponsor | Michael Hoelscher |
| Results posted | Yes |
2. Clinical Question
Population
Adults with newly diagnosed, smear-positive pulmonary tuberculosis. The primary endpoint was analysed in a modified intention-to-treat population; the exact rules defining that population are not reported in the registry record.
Intervention
Four experimental regimens were evaluated: HR35ZE, HRZQ, HR20ZQ, and HR20ZM. They used combinations of isoniazid, rifampicin at standard or increased doses, pyrazinamide, ethambutol, SQ109, or moxifloxacin. The experimental regimens were planned for 12 weeks, followed by 14 weeks of continuation treatment with standard-dose rifampicin and isoniazid.
Comparator
The trial description identifies a standard control regimen, HRZE. However, the endpoint results designate Arm 1 (R35), rather than HRZE, as the control. The registry record does not explain this inconsistency, so the identity of the intended endpoint comparator is unclear from the posted record.
Primary question
How long did it take participants to achieve stable sputum culture conversion in liquid media, defined as two consecutive negative weekly cultures, during the 0 - 12 weeks after enrollment? The registry reports medians and inter-quartile ranges by arm, but does not report a comparative treatment-effect estimate.
3. Trial Design
This was a randomized, open-label, phase 2 trial using a multiple-arm, multiple-stage design. The registry reports enrollment of 365 participants and describes five regimens: four experimental regimens and a standard control. Allocation was planned in the ratio 2:1:1:1:1. The record lists the trial as completed.
The experimental arms varied the antimicrobial combinations. HR35ZE included isoniazid, rifampicin 35 mg/kg, pyrazinamide, and ethambutol. HRZQ included isoniazid, standard-dose rifampicin, pyrazinamide, and SQ109 300 mg. HR20ZQ used rifampicin 20 mg/kg and SQ109 300 mg with isoniazid and pyrazinamide. HR20ZM used rifampicin 20 mg/kg and moxifloxacin 400 mg with isoniazid and pyrazinamide. HRZE was described as the standard regimen, containing isoniazid, standard-dose rifampicin, pyrazinamide, and ethambutol.
The trial description says that interim efficacy analyses were planned, with recruitment to experimental arms to stop if an arm fell below a prespecified efficacy threshold. It also reports that recruitment to HRZQ and HR20ZQ was stopped after the first scheduled interim analysis, following a recommendation from the independent data monitoring committee and a decision by the Trial Steering Committee. The reason given was that these arms did not meet the prespecified gain in efficacy over control; the description says safety concerns did not prompt the decision. Further details of the interim analysis and its statistical boundaries are not reported in the registry record.
Although the trial description names HRZE as the standard control, the primary endpoint results identify Arm 1 (R35) as the control. The record does not reconcile those labels. This matters when interpreting any apparent arm-to-arm comparison.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | HRZQ | Arm 1 (R35) | HR20ZQ | HR20ZM | HRZE |
|---|---|---|---|---|---|
| STARTED | 59 | 63 | 57 | 63 | 123 |
| COMPLETED | 53 | 57 | 52 | 58 | 117 |
| NOT COMPLETED | 6 | 6 | 5 | 5 | 6 |
Analysis population for the primary outcome, as defined in the registry: Modified intention to treat analysis
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.
| Characteristic | Unit | HRZQ | Arm 1 (R35) | HR20ZQ | HR20ZM | HRZE | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 59 | 63 | 57 | 63 | 123 | 365 | |
| Age, Customized | years | 32 (25 to 40) | 33 (23 to 40) | 34 (27 to 41) | 31 (24 to 38) | 34 (26 to 41) | 32.9 (23.8 to 40.2) |
| Sex: Female, Male: Female | Participants | 21 | 21 | 12 | 24 | 29 | 107 |
| Sex: Female, Male: Male | Participants | 38 | 42 | 45 | 39 | 94 | 258 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 50 | 51 | 50 | 48 | 101 | 300 |
| Race (NIH/OMB): White | Participants | 0 | 1 | 1 | 0 | 0 | 2 |
| Race (NIH/OMB): More than one race | Participants | 9 | 11 | 6 | 15 | 19 | 60 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 3 | 3 |
| HIV Positive Participants | participants | 5 | 4 | 3 | 3 | 9 | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media, measured over 0 - 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint was time from enrollment to stable culture conversion in liquid media. Conversion required two consecutive negative weekly cultures. The assessment window was 0 - 12 weeks, and the outcome was summarized as a median number of days with an inter-quartile range for the modified intention-to-treat population.
Time to culture conversion captures both whether cultures become negative and how quickly that occurs within the assessment period. It is a time-to-event outcome: each participant contributes information about the time until the defined event, or may not have a recorded event during the period. In general, the median is the time by which half of the analysed group has experienced the event, when it can be estimated. The inter-quartile range describes the middle half of observed times and conveys how spread out those times are.
Culture conversion is a microbiological measure used to describe response during tuberculosis treatment. It is not, by itself, a complete account of later clinical outcomes or long-term disease status. The registry reports arm-level medians and inter-quartile ranges, but not comparative hazard ratios, confidence intervals, or p-values for this endpoint. The record also does not give further detail about handling participants without conversion during follow-up.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary endpoint, the reported median time to culture conversion was 48 days (inter-quartile range 34 to 69) in Arm 1 (R35), 63 days (48 to 83) in HRZQ, 66 days (41 to 83) in HR20ZQ, 55 days (41 to 69) in HR20ZM, and 62 days (41 to 83) in HRZE. These are descriptive summaries for each arm, not estimates of the difference between regimens. The ranges overlap, and the registry does not post a formal comparative estimate or its uncertainty.
A shorter median time indicates that the midpoint of observed conversion times occurred earlier in that arm. That descriptive interpretation should not be treated as proof of a between-arm effect. Comparing medians alone does not account for censoring, variation in follow-up, or the trial’s randomization and analysis procedures. A confidence interval around a comparative estimate would help describe the precision of the estimated treatment contrast; no such interval is reported for the primary endpoint.
The comparator designation also needs caution. The trial description calls HRZE the standard control, while the endpoint results mark Arm 1 (R35) as the control. Without clarification in the registry record, the medians should be read using their arm labels rather than assuming which one was the intended control. The reported values do not resolve this labeling issue.
The registry description states that HRZQ and HR20ZQ recruitment stopped after the first scheduled interim analysis because the arms did not meet a prespecified gain in efficacy over control. That is a reported decision about the trial’s interim assessment; it does not supply the numerical contrast, decision boundary, or uncertainty underlying the decision. The posted endpoint summaries alone do not allow the reader to reconstruct that assessment. The description explicitly says the recruitment decision was not prompted by a safety concern.
Safety results list serious adverse events affecting 4 of 59 participants in HRZQ, 4 of 63 in Arm 1 (R35), 5 of 57 in HR20ZQ, 4 of 63 in HR20ZM, and 6 of 123 in HRZE. These are counts of participants affected, not a comparative safety analysis. The registry does not report deaths in these groups. A count without event-level detail, follow-up context, or comparative uncertainty cannot establish whether the regimens differ in safety.
Overall, the record supports a description of the arm-level culture-conversion distributions and posted adverse-event counts. It does not provide enough comparative statistical output to quantify the magnitude or precision of differences between regimens. The observed summaries should not be interpreted as establishing that any regimen is superior or equivalent.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure. For each participant, the event is stable culture conversion, defined in the registry as two consecutive negative weekly cultures in liquid media. Time is counted from enrollment. In general, time-to-event methods are useful when the timing of an event matters and when some participants may not experience the event during the observation period. Participants without a recorded event by the end of follow-up may be censored, meaning their exact event time is unknown but their observed follow-up still contributes information. The registry record does not report the detailed censoring rules used for this analysis.
The reported arm summaries are medians and inter-quartile ranges. In general, the median locates the middle of a distribution, while the inter-quartile range describes the interval between its lower and upper quartiles. These summaries can describe skewed time distributions without requiring a normal distribution. They do not, on their own, estimate a treatment contrast or show the precision of a contrast. The registry record does not post confidence intervals or p-values for the arm comparisons.
For an inferential comparison of time-to-event outcomes, methods can use event timing and account for censoring. A hazard ratio is one possible comparative measure: in general, it summarizes the relative instantaneous event rate between groups over follow-up, under assumptions about how that relative rate behaves. It is not the same as a ratio of medians or a difference in median times. No sponsor-reported hazard ratios for this primary endpoint appear in the posted results, and the record does not report the model, covariates, or diagnostics that would be needed to evaluate such an analysis.
The study is described as randomized and open label. Randomization is intended, in general, to make assigned groups comparable on average with respect to both measured and unmeasured baseline characteristics. It does not guarantee balance in every realized trial, especially within individual arms. Open-label means treatment assignment was not masked; the registry says masking was none. For a laboratory outcome, the record does not say whether laboratory personnel were blinded to treatment assignment, so that detail is not reported in the registry record.
The trial used a multiple-arm, multiple-stage design. In general, this kind of design allows several experimental regimens to be assessed against a control and can include prespecified interim decisions about whether to continue recruiting to particular arms. Repeated interim looks and multiple comparisons create multiplicity concerns: unless the design accounts for them, the chance of a false-positive conclusion across a family of tests may differ from the nominal level for a single test. The record reports a planned interim efficacy process and stopping of recruitment to two arms, but the statistical boundaries, multiplicity adjustment, and full analysis plan are not reported in the registry record. The stopping information should therefore be read as the registry’s account of the trial decision, not as a complete statistical report.
The registry states that the primary analysis population was modified intention to treat. In general, an intention-to-treat analysis aims to retain participants in their randomized groups, while a modified version applies specified exclusions or eligibility rules. Those rules can affect which participants contribute to the endpoint and how departures from assigned treatment are handled. The exact modified intention-to-treat definition, participant flow, missing-data handling, and sensitivity analyses are not reported in the registry record. The results list different arm counts for the endpoint and safety summaries; the record does not explain these differences.
The record also includes planning assumptions for an illustrative sample-size exercise based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and target effects expressed as fractions of the observed effect. These are planning illustrations, not observed power and not evidence of the trial’s original design justification. The sample-size justification used to plan the actual trial is not reported in the registry record. The posted information does not give the numerical planning results, so no participant-count recommendations can be inferred from the assumptions alone.
For general interpretation, over-dispersion matters when outcome variability is greater than a statistical model expects. A model that understates variability can produce confidence intervals that are too narrow and tests that are too optimistic. The primary outcome is a time-to-event endpoint, and the record does not describe a count model or report whether over-dispersion was assessed. The concept is relevant to statistical modeling generally, but no conclusion about over-dispersion in this trial can be drawn from the posted results.
10. Multiplicity, Missing Data and Analysis Populations
The multiple-arm, multiple-stage design involved several experimental regimens and a planned interim efficacy process. In general, assessing several arms and examining results at interim stages raises multiplicity questions because repeated opportunities to make decisions can affect error rates. The registry describes the decision to stop recruitment to HRZQ and HR20ZQ after an interim assessment, but does not report the statistical boundaries, adjustment method, or full multiplicity strategy. Those details are not reported in the registry record.
The primary endpoint is reported as arm-level medians and inter-quartile ranges. Comparative estimates, confidence intervals, and p-values are not posted, so the precision and statistical evidence for pairwise contrasts cannot be assessed from these summaries. The record indicates that values were missing or not estimable for a two-arm comparison of the median-time endpoint. It does not explain which comparisons were affected or why they could not be estimated.
The primary analysis population is described as modified intention to treat, but the definition is not reported. Participant flow by randomized arm, reasons for exclusion, and the handling of missing culture measurements are also not reported in the registry record. In general, missing outcome data can affect both the estimated event-time distribution and the comparability of groups if missingness differs across arms or relates to participants’ outcomes. No sensitivity analyses addressing this issue are reported.
The record lists an overall enrollment of 365, while the endpoint and safety summaries give arm-specific counts that vary by outcome. It does not explain the relationship between those totals, the randomized population, and the analysed populations. The original sample-size justification and detailed statistical analysis plan are not reported 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 |
|---|---|---|---|
| HRZQ | 4 | 59 | 6.8% |
| Arm 1 (R35) | 4 | 63 | 6.3% |
| HR20ZQ | 5 | 57 | 8.8% |
| HR20ZM | 4 | 63 | 6.3% |
| HRZE | 6 | 123 | 4.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HRZQ | 49 of 59 |
| Arm 1 (R35) | 53 of 63 |
| HR20ZQ | 42 of 57 |
| HR20ZM | 49 of 63 |
| HRZE | 92 of 123 |
Most frequent serious adverse event terms
| Event term | Organ system | HRZQ | Arm 1 (R35) | HR20ZQ | HR20ZM | HRZE |
|---|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | 1 of 59 | 0 of 63 | 3 of 57 | 0 of 63 | 0 of 123 |
| Upper gastrointestinal bleeding | Gastrointestinal disorders | 0 of 59 | 0 of 63 | 0 of 57 | 1 of 63 | 0 of 123 |
| Psychosis | Psychiatric disorders | 0 of 59 | 0 of 63 | 0 of 57 | 1 of 63 | 0 of 123 |
| Arthritis of ankles | Musculoskeletal and connective tissue disorders | 0 of 59 | 0 of 63 | 0 of 57 | 1 of 63 | 0 of 123 |
| Acute Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 59 | 0 of 63 | 0 of 57 | 1 of 63 | 0 of 123 |
| Seizure | Nervous system disorders | 0 of 59 | 0 of 63 | 1 of 57 | 0 of 63 | 0 of 123 |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0 of 59 | 0 of 63 | 1 of 57 | 0 of 63 | 0 of 123 |
| left pneumothorax | Respiratory, thoracic and mediastinal disorders | 0 of 59 | 0 of 63 | 1 of 57 | 0 of 63 | 0 of 123 |
| Intrahepatic cholestasis | Hepatobiliary disorders | 0 of 59 | 0 of 63 | 1 of 57 | 0 of 63 | 0 of 123 |
| Parasuicide | Psychiatric disorders | 1 of 59 | 0 of 63 | 0 of 57 | 0 of 63 | 0 of 123 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HRZQ | Arm 1 (R35) | HR20ZQ | HR20ZM | HRZE |
|---|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 7 of 59 | 8 of 63 | 6 of 57 | 10 of 63 | 18 of 123 |
| Pruritus | Skin and subcutaneous tissue disorders | 6 of 59 | 11 of 63 | 5 of 57 | 9 of 63 | 17 of 123 |
| Vomiting | Gastrointestinal disorders | 5 of 59 | 11 of 63 | 8 of 57 | 8 of 63 | 15 of 123 |
| Nausea | Gastrointestinal disorders | 7 of 59 | 9 of 63 | 8 of 57 | 7 of 63 | 7 of 123 |
| headache | General disorders | 6 of 59 | 5 of 63 | 4 of 57 | 4 of 63 | 11 of 123 |
| haemoptysis | Blood and lymphatic system disorders | 7 of 59 | 3 of 63 | 4 of 57 | 5 of 63 | 7 of 123 |
| Rash | Skin and subcutaneous tissue disorders | 5 of 59 | 5 of 63 | 6 of 57 | 5 of 63 | 5 of 123 |
| Chest pain | Respiratory, thoracic and mediastinal disorders | 6 of 59 | 4 of 63 | 4 of 57 | 2 of 63 | 6 of 123 |
| Influenza | Infections and infestations | 5 of 59 | 4 of 63 | 1 of 57 | 4 of 63 | 7 of 123 |
| Diarrhoea | Gastrointestinal disorders | 4 of 59 | 2 of 63 | 2 of 57 | 5 of 63 | 4 of 123 |
Serious events with the highest arm-level rate: deep vein thrombosis (5.3%), seizure (1.8%), pulmonary embolism (1.8%), left pneumothorax (1.8%), intrahepatic cholestasis (1.8%).
The serious adverse-event figures count participants affected in each listed group: 4 of 59 in HRZQ, 4 of 63 in Arm 1 (R35), 5 of 57 in HR20ZQ, 4 of 63 in HR20ZM, and 6 of 123 in HRZE. These are participant counts, not counts of all serious events; one participant may have experienced more than one event, and the record does not give event totals by group. The registry does not report deaths for these groups.
The record also lists other adverse events affecting 49 of 59 participants in HRZQ, 53 of 63 in Arm 1 (R35), 42 of 57 in HR20ZQ, 49 of 63 in HR20ZM, and 92 of 123 in HRZE. These figures should be read as affected-participant counts, not as a comparative estimate of risk. The registry does not provide confidence intervals or a formal between-group safety analysis alongside these counts.
Serious-event terms listed include deep vein thrombosis (5.3%), seizure (1.8%), pulmonary embolism (1.8%), left pneumothorax (1.8%), intrahepatic cholestasis (1.8%), and parasuicide (1.7%). The record does not clarify the denominator or whether these percentages refer to participants, events, or a particular analysis population. It also does not give enough detail to infer how event severity, timing, or attribution differed by treatment group.
12. What the Result Does, and Does Not, Mean
The posted primary endpoint results describe the time to stable sputum culture conversion in liquid media for each arm. They show medians ranging from 48 days in Arm 1 (R35) to 66 days in HR20ZQ, with inter-quartile ranges reported for every arm. These values summarize the observed endpoint distributions; they are not, by themselves, formal estimates of treatment effects.
The record reports that recruitment to HRZQ and HR20ZQ was stopped following an interim assessment because those arms did not meet a prespecified gain in efficacy over control. It states that safety concerns did not prompt that decision. However, it does not post the numerical interim comparisons or the details of the decision rule, so readers cannot independently assess the strength or precision of that evidence from the registry record.
The record does not establish that one regimen is better, worse, or equivalent to another based on the posted endpoint summaries. It also does not establish that the listed adverse-event counts differ statistically between regimens. Such conclusions would require appropriate comparative analyses and uncertainty estimates, which are not reported for these outcomes.
The findings are specific to the trial’s population, regimens, endpoint definition, and follow-up window. The primary endpoint concerns culture conversion during 0 - 12 weeks; it is not a direct report of outcomes after that window. The record does not provide enough information to infer long-term outcomes, generalize to other patient populations, or judge the relative clinical importance of the observed arm summaries. The unclear designation of the endpoint control further limits interpretation of comparisons.
Thus, the registry record is informative about which arms were studied, the reported arm-level conversion summaries, the interim stopping account, and counts of affected participants. It is incomplete as a statistical comparison report. Absence of a posted comparative estimate should not be interpreted as evidence that no difference exists.
13. Why This Trial Matters Statistically
This trial illustrates the statistical complexity of evaluating multiple regimens within a single randomized study. A multiple-arm, multiple-stage design can make interim decisions part of the study strategy, but those decisions need to be interpreted alongside the prespecified statistical rules. The registry reports that two arms stopped recruitment after an interim efficacy assessment, yet the boundaries and comparative estimates underlying that decision are not reported. That gap makes it difficult to evaluate the decision quantitatively from the posted record.
It also demonstrates why descriptive summaries and comparative inference are different. Arm-level medians provide an accessible description of event timing, while comparative methods are needed to estimate how outcomes differ between groups and how precisely those differences are measured. Without comparative estimates and uncertainty intervals, readers cannot distinguish a potentially meaningful contrast from variation in observed data.
Clear labeling of treatment groups is equally important. The registry describes HRZE as the standard control but identifies Arm 1 (R35) as the control in the endpoint results. When the comparator is unclear, even correctly reported arm summaries can be difficult to interpret as a treatment comparison.
Finally, reporting the analysis population, participant flow, missing-data approach, and safety denominators would help readers assess how each result was produced and whom it represents. These details are central to interpreting multi-arm trials, particularly when arm recruitment stops at an interim stage. The posted record offers useful descriptive information, but its limits should remain visible when drawing statistical conclusions.
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 most important endpoint-reporting limitation is the absence of comparative estimates for the median-time outcome. The record provides arm-level medians and inter-quartile ranges, but not hazard ratios, confidence intervals, or p-values. It also states that values were missing or not estimable for a two-arm comparison without identifying the specific comparison or explaining the reason.
The control designation is inconsistent across the record: HRZE is described as the standard control regimen, while Arm 1 (R35) is marked as the control in the endpoint results. The registry record does not explain the discrepancy, limiting interpretation of the intended treatment contrasts.
The modified intention-to-treat population is not defined, and participant flow and exclusions are not reported. The record does not describe how missing cultures, participants without conversion, or differences in follow-up were handled. Endpoint and safety counts differ by arm, but their relationship to the randomized population is not explained.
Although the trial description reports interim stopping of HRZQ and HR20ZQ, it does not provide the interim estimates, statistical boundaries, multiplicity method, or complete analysis plan. The original sample-size justification is also not reported. Safety reporting gives affected-participant counts, but not event totals, deaths, comparative uncertainty, or clear denominators for the listed serious-event percentages. These reporting limitations prevent a full assessment of comparative efficacy and safety from the registry record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design — NCT01785186.
- Registry record last updated 2017-09-20; status last verified 2017-08.
- Results first posted 2017-09-20.
- 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
NCT01785186 was a completed, randomized, open-label phase 2 trial in adults with newly diagnosed, smear-positive pulmonary tuberculosis. It enrolled 365 participants and evaluated four experimental regimens alongside a standard control regimen in a multiple-arm, multiple-stage design.
The primary endpoint was time from enrollment to stable culture conversion in liquid media, defined as two consecutive negative weekly cultures, during 0 - 12 weeks. Arm-level medians and inter-quartile ranges were posted for the modified intention-to-treat population. The record also reports that recruitment to HRZQ and HR20ZQ stopped after an interim efficacy assessment, and lists serious and other adverse-event counts by group.
Comparative endpoint estimates, detailed interim methods, the modified intention-to-treat definition, and the original sample-size justification are not reported in the registry record. The difference between the described standard control and the endpoint’s control label is unresolved.