Drugs / Ampicillin
Ampicillin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | OMNIPEN (AMPICILLIN) | — | 1965-12-17 | fda.gov ↗ |
Trials 26 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01433757 Comparator | Sep 2011 → Jun 2017 | inherited dystonia | University of Florida | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07318584 Comparator | Mar 2026 → Feb 2028 expected | escherichia coli discitis | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03453177 Background | Mar 2018 → Mar 2019 | neonatal sepsis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2 | NCT02424734 Background | Aug 2015 → Dec 2017 | neonatal sepsis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00760006 Comparator | May 2008 → Aug 2015 | cleft palate | Joseph Losee | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT05051163 Comparator | Jun 2021 → Jun 2024 | HIV infectious disease, protein-energy malnutrition | Makerere University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02605122 Comparator | Apr 2016 → Mar 2018 | bacterial pneumonia | Melinta Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT01994993 Comparator | Dec 2013 → Jan 2017 | — | Michael Cohen-Wolkowiez | Completed | No outcome recorded |
| Phase 2/3 | NCT00879190 Comparator | May 2009 → Jun 2012 | chorioamnionitis | Stanford University | Completed | No outcome recorded |
| Phase 2/3 | NCT01633294 Comparator | Oct 2008 → Jan 2011 | chorioamnionitis, endometritis, infectious meningitis, neonatal sepsis | Hospital de Santa Maria, Portugal | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07326540 Comparator | Mar 2026 → Dec 2027 expected | Acinetobacter infectious disease, bacterial pneumonia | BioVersys SAS | Recruiting | No outcome recorded |
| Phase 3 | NCT05977400 Comparator | Apr 2024 → Mar 2029 expected | neurodevelopmental disorder | Sharp HealthCare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06048692 Comparator | Jan → Sep 2023 | — | Beni-Suef University | Unknown | No outcome recorded |
| Phase 3 | NCT03060473 Background | Feb 2017 → Dec 2023 | preterm premature rupture of the membranes | The University of Texas Medical Branch, Galveston | Terminated | No outcome recorded |
| Phase 3 | NCT02579161 Comparator | Sep 2014 → Mar 2018 | urolithiasis | Northwell Health | Completed | No outcome recorded |
| Phase 3 | NCT01551394 Comparator | Sep 2012 → Dec 2014 | infectious disease with sepsis | PENTA Foundation | Completed | No outcome recorded |
| Phase 3 | NCT01045902 Comparator | Feb 2001 → Jan 2005 | aspiration pneumonia, lung abscess | Bayer | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT07563504 Comparator | Jul 2026 → Jan 2027 expected | — | Sarawak General Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06712641 Comparator | Apr 2026 → Jun 2028 expected | infectious disease with sepsis | University Hospital, Akershus | Recruiting | No outcome recorded |
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT07183462 Background | Sep 2025 → Jun 2029 expected | pregnancy disorder, preterm premature rupture of the membranes | Sheba Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06440304 Comparator | Jan 2025 → Dec 2026 expected | bacterial infectious disease with sepsis | Clinical Hospital Centre Zagreb | Recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05206500 Background | May 2022 → Dec 2028 expected | urinary tract infection | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT03997266 Comparator | Aug 2020 → Jan 2026 | neonatal sepsis, perinatal necrotizing enterocolitis | Michael Morowitz | Completed | No outcome recorded |
| Phase 4 | NCT02819570 Comparator | Nov 2015 → Dec 2017 | preterm premature rupture of the membranes | Western Galilee Hospital-Nahariya | Unknown | No outcome recorded |
| Phase 4 | NCT02384200 Background | Mar 2015 → Feb 2017 | nephrolithiasis, urinary tract infection | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT01888822 Comparator | Jun 2013 → Jun 2016 | cholelithiasis | University of Roma La Sapienza | Terminated | No outcome recorded |
| Phase 4 | NCT00887276 Comparator | Nov 2008 → Jan 2011 | — | University of Ulm | Terminated | No outcome recorded |
| Phase 4 | NCT00630513 Comparator | Jan 2008 → Jun 2010 | infectious peritonitis | University of Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00368537 Comparator | Sep 2006 → Sep 2008 | skin disease caused by bacterial infection | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT07442357 Comparator | Jun 2026 → Jun 2029 expected | aortic valve stenosis | Rigshospitalet, Denmark | Not yet recruiting | No outcome recorded |
| — | NCT07118384 Comparator | May 2025 → Jan 2026 overdue | Acinetobacter infectious disease | Cairo University | Recruiting | No outcome recorded |
| — | NCT07148622 Comparator | Oct 2024 → Aug 2025 | preterm premature rupture of the membranes | Yuzuncu Yil University | Completed | No outcome recorded |
| — | NCT05469984 Comparator | Nov 2022 → Sep 2025 overdue | preterm premature rupture of the membranes | Western Galilee Hospital-Nahariya | Recruiting | No outcome recorded |
| — | NCT04202380 Background | Jan 2020 → Jan 2021 | preterm premature rupture of the membranes | Assiut University | Completed | No outcome recorded |
| — | NCT02865564 Comparator | Nov 2016 → Mar 2020 | digestive system disorder | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT03473210 Comparator | Oct 2016 → Dec 2017 | preterm premature rupture of the membranes | Cairo University | Completed | No outcome recorded |
| — | NCT02829060 Comparator | Jan 2016 → Jan 2025 | infectious disease with sepsis, nephrolithiasis, urinary tract infection | University of California, San Diego | Completed | No outcome recorded |
| — | NCT02477423 Comparator | Jul 2015 → Jun 2019 | perinatal necrotizing enterocolitis, pulmonary immaturity | University of Chicago | Completed | No outcome recorded |
| — | NCT01945450 Comparator | Jan 2014 → Sep 2016 | endometritis | Hadassah Medical Organization | Unknown | No outcome recorded |
| — | NCT00814905 Comparator | Nov 2008 → Jan 2012 | chorioamnionitis | United States Naval Medical Center, Portsmouth | Withdrawn | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ampicillin | “Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI” NCT07442357 ↗56“Empirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)” NCT06712641 ↗ “ampicillin 50mg/kg twice daily and gentamicin \[3mg/kg for babies \<2kg or 5mg/kg for babies \>2kg\] once daily for 7 days, as per Kenyan guidelines).” NCT03453177 ↗ “These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid.” NCT02605122 ↗ “ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days” NCT03473210 ↗ “Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours” NCT06917157 ↗ “Intravenous antibiotics: 1) Penicillins; ampicillin, piperacillin/tazobactam” NCT07236944 ↗ “Isolated strains sensitive to ampicillin: ampicillin 2g/6 or 8h (i.v)” NCT05394298 ↗ “Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion.” NCT06423898 ↗ “Ampicillin or Gentamicin or Cefotaxime” NCT02784821 ↗ “Ampicillin/Amoxicillin” NCT05206500 ↗ “Ampicillin 2g IV/6h” NCT02795949 ↗ “Ampicillin” NCT02099240 ↗ “Ampicillin” NCT03108690 ↗ |
| Known as | Ampicillin/sulbactam | “Beta lactam antibiotics for non-ESBL E. coli infections include preferred ceftriaxone or alternative cephalosporins (cefepime, ceftazidime), penicillins...” NCT07318584 ↗14“To compare the clinical effectiveness of two different sulbactam-based regimens (ampicillin-sulbactam versus cefoperazone-sulbactam) in the treatment of Acinetobacter baumannii...” NCT07118384 ↗ “Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD” NCT06048692 ↗ “Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study.” PMID 21118502 ↗ Nov 2010 “Ampicillin-Sulbactam*” NCT02099240 ↗ |
| Known as | AMS | “Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD” NCT06048692 ↗ |
| Known as | Unasyn | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00760006 ↗ |
| Action | Inhibit | “Sulbactam, a beta-lactamase inhibitor, is commercially available mainly in combination with β-lactam antibiotics” NCT07118384 ↗ |
| Route | Oral | “second oral course of antibiotics consisting of metronidazole and ampicillin or placebo every 4 hours” NCT00021671 ↗ |