Comparison · NCT01570192-sae
IV Meropenem; Parenteral Aminoglycoside vs I.V. Meropenem: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. IV Meropenem; Parenteral Aminoglycoside vs I.V. Meropenem: serious adverse events. Trial comparisons, record NCT01570192-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01570192-sae
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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 | 0.462 | 0.232 | 0.709 | wilson | |
| Risk in group 2 | 0.367 | 0.219 | 0.545 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0949 | -0.196 | 0.383 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.593 | 2.67 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.396 | 5.54 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IV Meropenem; Parenteral Aminoglycoside than on I.V. Meropenem | 10.5 | 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 | IV Meropenem; Parenteral Aminoglycoside | Subjects assigned to this group will receive:~* IV meropenem (2 g infused over 3 hrs q 8 hr);~* a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~* tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day | 6 | 13 | EG000 |
| Group 2 | I.V. Meropenem | Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~\*\*NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage. | 11 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Clinical Trials to Reduce the Risk of Antimicrobial Resistance
- NCT number
- NCT01570192
- Phases
- PHASE2
- Conditions
- Bacterial Pneumonia
- Interventions
IV meropenem, I.V. Meropenem, Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h, Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage., tobramycin nebulization
- Lead sponsor
- University of Florida
- Results first posted
- 2017-04-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01570192?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
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GET https://conductscience.org/api/comparisons/v1/NCT01570192-sae