Summary
Sulbactam 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 6 registered trials linking Sulbactam to Sepsis: 4 are currently recruiting; 2 have completed. The most advanced is Phase 4 (NCT07004049). It plans or enrolled 600 participants. Registration activity spans 2019 to 2025. The literature layer holds 12 publications for this pair: 5 Cochrane reviews, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1989 to 2026. 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 | 6 total: 4 recruiting, 0 active / not yet recruiting, 2 completed, 0 other |
| Linked publications | 12 (5 Cochrane reviews, 5 clinical trial publications, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT07004049 | Optimising TREATment for Severe Gram-Negative Bacterial Infections 2025 | recruiting | Phase 4 | 600 |
| NCT06440304 | Therapeutic Options for CRAB 2025 | recruiting | Phase 4 | 108 |
| NCT03894046 | Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex 2019 | completed | Phase 3 | 207 |
| NCT04724044 | Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia 2021 | completed | Phase 3 | 278 |
| NCT06294600 | Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) 2024 | recruiting | Phase 3 | 330 |
| NCT07601711 | Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study 2025 | recruiting | Not applicable | 200 |
Published literature
- Cochrane review The Role of Combination Antibiotic Therapy in Combatting Drug-Resistant Acinetobacter baumannii Infections: A Systematic Review of Randomised Control TrialsGezmu AA, Tesfaye AW, Coates ARM · Antibiotics (Basel, Switzerland) · 2026 · PMID 42041319
- Clinical trial publication The clinical and paraclinical effectiveness of four-hour infusion vs. half-hour infusion of high-dose ampicillin-sulbactam in treatment of critically ill patients with sepsis or septic shock: An assessor-blinded randomized clinical trialMirjalili M, Zand F, Karimzadeh I et al. · Journal of critical care · 2023 · PMID 36272277
- Systematic review Hemoptysis caused by Parvimonas micra: case report and literature reviewShao A, He Q, Jiao X et al. · Frontiers in public health · 2023 · PMID 38389952
- Cochrane review Determining the optimal antibiotic regimen for chorioamnionitis: A systematic review and meta-analysisAlrowaily N, D'Souza R, Dong S et al. · Acta obstetricia et gynecologica Scandinavica · 2021 · PMID 33191493
- Cochrane review Effect on perinatal outcome of prophylactic antibiotics in preterm prelabor rupture of membranes: network meta-analysis of randomized controlled trialsChatzakis C, Papatheodorou S, Sarafidis K et al. · Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2020 · PMID 31633844
- Clinical trial publication A Non-inferiority Pilot Study Comparing the Clinical Efficacy and Safety of Generic Wide-spectrum Antibiotic Use in Septic Oncology PatientsAraya I, Fasce G, Núñez E et al. · Drug research · 2015 · PMID 25811220
- Cochrane review Antibiotic regimens for management of intra-amniotic infectionChapman E, Reveiz L, Illanes E et al. · The Cochrane database of systematic reviews · 2014 · PMID 25526426
- Cochrane review Antibiotics for meconium-stained amniotic fluid in labour for preventing maternal and neonatal infectionsSiriwachirachai T, Sangkomkamhang US, Lumbiganon P et al. · The Cochrane database of systematic reviews · 2014 · PMID 25374369
- Clinical trial publication Detection of interleukin-6 in maternal plasma predicts neonatal and infectious complications in preterm premature rupture of membranesLewis DF, Barrilleaux PS, Wang Y et al. · American journal of perinatology · 2001 · PMID 11731892
- Clinical trial publication A prospective, double-blind, randomized, controlled clinical trial of ampicillin-sulbactam for preterm premature rupture of membranes in women receiving antenatal corticosteroid therapyLovett SM, Weiss JD, Diogo MJ et al. · American journal of obstetrics and gynecology · 1997 · PMID 9166164
- Clinical trial publication Latency period after preterm premature rupture of membranes: a comparison of ampicillin with and without sulbactamLewis DF, Fontenot MT, Brooks GG et al. · Obstetrics and gynecology · 1995 · PMID 7651649
- Randomized controlled trial Randomised study of prophylactic parenteral sulbactam/ampicillin and cephazolin in biliary surgery: significant benefit in jaundiced patientsMorris DL, Jones JA, Harrison JD et al. · The Journal of hospital infection · 1989 · PMID 2567755
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 Sulbactam approved for Sepsis?
Sulbactam 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 Sulbactam in clinical trials for Sepsis?
ClinicalTrials.gov lists 6 registered trials linking Sulbactam to Sepsis: 4 are currently recruiting; 2 have completed. The most advanced is Phase 4 (NCT07004049). It plans or enrolled 600 participants. Registration activity spans 2019 to 2025.
What does the evidence show for Sulbactam in Sepsis?
Sulbactam 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.