Comparison · NCT06059846-sae
TBP-PI-HBr vs Imipenem-cilastatin: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. TBP-PI-HBr vs Imipenem-cilastatin: serious adverse events. Trial comparisons, record NCT06059846-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06059846-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0344 | 0.0241 | 0.049 | wilson | |
| Risk in group 2 | 0.0261 | 0.0173 | 0.0392 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00833 | -0.00835 | 0.0253 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.765 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.758 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TBP-PI-HBr than on Imipenem-cilastatin | 120 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TBP-PI-HBr | Participants received TBP-PI-HBr 600 mg, two x 300mg film-coated tablets, PO and a dummy infusion IV, q6h from Day 1 through Day 10. Participants with estimated baseline CrCl \>30 mL/min and ≤ 50 mL/min received TBP-PI-HBr 300 mg q6h. | 29 | 843 | EG000 |
| Group 2 | Imipenem-cilastatin | Participants received imipenem-cilastatin 500 mg, IV and matched dummy tablets, PO, q6h from Day 1 through Day 10. Dose adjustments for imipenem-cilastatin were made for participants with estimated baseline CrCl \< 90mL/min per approved imipenem-cilastatin package insert. Participants with baseline CrCl ≥ 60 to \< 90 mL/min were administered imipenem-cilastatin, 400 mg IV q6h and participants with baseline CrCl levels \>30 to \<60 mL/min, were administered 300mg IV, q6h. | 22 | 844 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug (Day 1) up to last follow-up visit (Day 28)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- NCT number
- NCT06059846
- Phases
- PHASE3
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion, Dummy Tablets
- Lead sponsor
- Spero Therapeutics
- Results first posted
- 2026-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06059846?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT06059846-sae