Summary
Tazobactam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Sepsis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Sepsis. ClinicalTrials.gov lists 8 registered trials linking Tazobactam to Sepsis: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03671967). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2011 to 2026. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2016 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Sepsis ranks 518 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not applicable — sepsis is an acute life-threatening syndrome; hospital mortality 15-25% for sepsis, 30-45% for septic shock with standard care; long-term complications (post-sepsis syndrome) in 50-70% of survivors.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 77.0 (trials 27.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 1 active / not yet recruiting, 3 completed, 2 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADORA2A |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03671967 | PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN) 2019 | recruiting | Phase 4 | 1,084 |
| NCT05981079 | Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis. 2023 | status unknown | Phase 4 | 332 |
| NCT03108690 | Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia 2017 | withdrawn | Phase 4 | — |
| NCT02820987 | PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock 2016 | completed | Phase 3 | 119 |
| NCT07575009 | Continuous Antibiotic Infusion In Children 2026 | recruiting | Phase 3 | 150 |
| NCT01431326 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care 2011 | completed | Not applicable | 3,520 |
| NCT05971979 | Therapeutic Drug Monitoring - Targeting IMproved Effectiveness 2023 | completed | Not applicable | 30 |
| NCT06977165 | Investigating the Impact of Sepsis Phenotypes on Antibiotic Treatment in Patients With Severe Pneumonia and Sepsis 2025 | not yet recruiting | Not applicable | 119 |
Published literature
- Clinical trial publication Empiric Antibiotic Therapy in Suspected Sepsis: Impact of Gentamicin-Based Regimens on Incident Renal Failure and MortalityHovind MJ, Berdal JE, Dalgard O et al. · Open forum infectious diseases · 2025 · PMID 40568002
- Clinical trial publication Continuous versus intermittent bolus dosing of beta-lactam antibiotics in a South African multi-disciplinary intensive care unit: A randomized controlled trialKhan AB, Abdul-Aziz MH, Hindle L et al. · The Journal of infection · 2025 · PMID 40239817
- Clinical trial publication Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients (BEATLE): a randomized, multicentre, open-label, superiority clinical trialLaporte-Amargos J, Carmona-Torre F, Huguet M et al. · Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2025 · PMID 39433124
- Cochrane review Role of antibiotic prophylaxis in liver transplant patients undergoing endoscopic retrograde cholangiopancreatography: a systematic review and meta-analysisNadeem MA, Awan AR, Rao AG et al. · EClinicalMedicine · 2025 · PMID 41140449
- Clinical trial publication Unraveling the impact of therapeutic drug monitoring via machine learning for patients with sepsisAtes HC, Alshanawani A, Hagel S et al. · Cell reports. Medicine · 2024 · PMID 39127039
- Clinical trial publication Continuous vs Intermittent β-Lactam Antibiotic Infusions in Critically Ill Patients With Sepsis: The BLING III Randomized Clinical TrialDulhunty JM, Brett SJ, De Waele JJ et al. · JAMA · 2024 · PMID 38864155
- Randomized controlled trial Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis: the EASI-SWITCH RCTCoyle V, Forde C, Adams R et al. · Health technology assessment (Winchester, England) · 2024 · PMID 38512064
- Cochrane review Risk factors for vancomycin-associated acute kidney injury: A systematic review and meta-analysisKim JY, Yee J, Yoon HY et al. · British journal of clinical pharmacology · 2022 · PMID 35665530
- Cochrane review Infective endocarditis by Enterobacter cloacae: a systematic review and meta-analysisIoannou P, Vamvoukaki R, Kofteridis DP · Journal of chemotherapy (Florence, Italy) · 2022 · PMID 34369324
- Cochrane review Antibiotic regimens for early-onset neonatal sepsisKorang SK, Safi S, Nava C et al. · The Cochrane database of systematic reviews · 2021 · PMID 33998666
- Cochrane review Piperacillin/tazobactam vs carbapenems for patients with bacterial infection: Protocol for a systematic reviewPetersen MW, Perner A, Sjövall F et al. · Acta anaesthesiologica Scandinavica · 2019 · PMID 31020663
- Systematic review Major publications in critical care pharmacotherapy literature in 2018Newsome AS, Bissell BD, Burry LD et al. · Journal of critical care · 2019 · PMID 31100708
- Meta-analysis Continuous versus Intermittent β-Lactam Infusion in Severe Sepsis. A Meta-analysis of Individual Patient Data from Randomized TrialsRoberts JA, Abdul-Aziz MH, Davis JS et al. · American journal of respiratory and critical care medicine · 2016 · PMID 26974879
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Tazobactam approved for Sepsis?
Tazobactam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Sepsis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Sepsis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tazobactam in clinical trials for Sepsis?
ClinicalTrials.gov lists 8 registered trials linking Tazobactam to Sepsis: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03671967). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2011 to 2026.
What does the evidence show for Tazobactam in Sepsis?
Tazobactam has both completed registered trials and synthesis-level publications linked to Sepsis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.