Comparison · NCT04983901-e7204583
Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the mMITT Analysis Set at LFU.
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. Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the mMITT Analysis Set at LFU. Trial comparisons, record NCT04983901-e7204583. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04983901-e7204583
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 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.242 | 0.354 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | 0 | 7 | OG000 |
| Group 2 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. | 0 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Infection-related Mortality in the mMITT Analysis Set at LFU.
- Description
- The secondary efficacy outcome is Infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU).
- Time frame
- 35 to 42 days after the start of inpatient IV study drug.
- Population
Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
Source ClinicalTrials.gov
Trial
- Title
- PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
- NCT number
- NCT04983901
- Phases
- PHASE2
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Interventions
- Imipenem/Cilastatin/Relebactam, Cefepime, Meropenem, Piperacillin-Tazobactam, Vancomycin, Daptomycin, Linezolid
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2024-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04983901?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/NCT04983901-e7204583