Drugs / Cefotaxime
Cefotaxime
also known as
Cefcil · Cefotaxim hikma · Cefotaxima · CEFOTAXIME SODIUM · Cefotaxime sodium salt · Claforan · HR 756 · Imetoxim · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CLAFORAN | — | 1996-09-27 | fda.gov ↗ |
| Approved | US (FDA) | CLAFORAN | — | 1981-03-11 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01059890 | Sep 2009 → Jun 2013 | bacterial infectious disease, brain injury | Poitiers University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00187655 | Jan 2004 → Dec 2011 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT02784821 | Jan 2017 → Sep 2019 | bacterial infectious disease, bronchopulmonary dysplasia, intestinal perforation, intracerebral hemorrhage +3 | University of Florida | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04168099 | Dec 2018 → Dec 2028 expected | infectious peritonitis | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT02389036 | May 2017 → Apr 2023 | critical illness polyneuropathy, infectious disease with sepsis | The George Institute | Completed | No outcome recorded |
| Phase 3 | NCT02795949 | Oct 2016 → Jan 2020 | bacterial infectious disease | Andalusian Public Foundation for Health Research in Seville | Completed | Met primary |
| Phase 46 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT06766461 | Jan 2025 → Dec 2026 expected | infectious disease with sepsis | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05427747 | Jan 2023 → Jan 2024 | infectious peritonitis | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03922919 | Apr 2018 → Apr 2020 | bacterial infectious disease | Centre Hospitalier Universitaire de Besancon | Unknown | No outcome recorded |
| Phase 4 | NCT02560207 | Nov 2015 → Jun 2016 | — | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 4 | NCT01540838 | Feb 2012 → Feb 2017 | bacterial meningitis | University of Helsinki | Completed | Missed primary |
| Phase 4 | NCT01559753 | Jan 1998 → Sep 2002 | — | Centre Hospitalier Universitaire de Besancon | Completed | Met primary |
| Phase not applicable2 trials | ||||||
| — | NCT04839653 | May 2021 → Apr 2022 | acute respiratory distress syndrome, bacterial infectious disease, infectious disease with sepsis, pneumonia | MEDSI Clinical Hospital 1, ICU | Unknown | No outcome recorded |
| — | NCT02388035 | Mar → May 2015 | infectious peritonitis | Dr Ahmed Ali Elbaz | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT04879030 Background | Jan → Aug 2020 | chronic obstructive pulmonary disease | Haiphong University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 3 | NCT02659033 Comparator | Mar 2016 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT02443285 Comparator | Jan 2015 → Dec 2019 | infectious peritonitis | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT01551394 Comparator | Sep 2012 → Dec 2014 | infectious disease with sepsis | PENTA Foundation | Completed | 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 | NCT02959957 Comparator | May 2016 → Aug 2019 | urinary tract infection | Håkan Hanberger | Completed | No outcome recorded |
| Phase 4 | NCT01820026 Comparator | Dec 2012 → May 2015 | cirrhosis of liver | University of Roma La Sapienza | Unknown | Met primary |
| Phase 4 | NCT02123628 Comparator | Jun 2007 → Jun 2010 | diabetes mellitus | Tourcoing Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01265173 Comparator | Apr 2007 → Jun 2018 | cirrhosis of liver | Korea University | Completed | Missed primary |
| — | NCT07043855 Comparator | May 2026 → Oct 2028 expected | infectious disease | Asan Medical Center | Enrolling by invitation | No outcome recorded |
| — | NCT05804123 Background | Oct 2021 → Apr 2024 | respiratory tract infectious disorder | Anabio R&D | Completed | No outcome recorded |
| — | NCT02800785 Comparator | May 2016 → Mar 2020 | appendicitis | University of Washington | Completed | No outcome recorded |
| — | NCT02515565 Background | Sep 2015 → Apr 2018 | pneumonia | University of Granada | Unknown | No outcome recorded |
| — | NCT01828892 Background | Mar 2014 → Jun 2017 | intestinal fistula | Jinling Hospital, China | Unknown | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cefotaxime | “Children aged 2 months to 15 years presenting to hospital with symptoms and signs of bacterial meningitis were randomized to receive, for the first 4 days, a continuous...” PMID 32246138 ↗ May 202130“Patients not already receiving a therapeutic antibiotic will be prescribed cefotaxime 1g six-hourly or ceftriaxone 1g daily, with dose adjusted as appropriate for organ...” NCT02389036 ↗ “Second- or third-generation cephalosporin (cefuroxime, cefotaxime, or ceftriaxone) with or without erythromycin, given parenterally; parenteral therapy should continue until...” NCT02515565 ↗ “The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam, ticarcillin-clavulanate, imipenem-cilastin, meropenem,...” NCT04879030 ↗ “standard to double dosing of beta-lactam antibiotics (cefuroxime, ceftazidime, ceftriaxone, cefotaxime, amoxicillin, amoxicillin/clavulanic acid,” PMID 40119275 ↗ Mar 2025 “followed by postoperative cefotaxime plus metronidazole for 3 days” NCT07043855 ↗ “2) cephalosporins; cefotaxime, cefuroxime, ceftriaxone” NCT07236944 ↗ “* Cefotaxime IV 100mg/kg in three IV infusions daily” NCT02123628 ↗ “Cefotaxime 1-2g IV/8h ó ceftriaxone 1 g/12-24h” NCT02795949 ↗ “Ampicillin or Gentamicin or Cefotaxime” NCT02784821 ↗ “Cefotaxime*” NCT02099240 ↗ |
| Known as | Cefcil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Cefotaxim hikma | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Cefotaxima | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | CEFOTAXIME SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Cefotaxime sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Claforan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | HR 756 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Imetoxim | “Imetoxim 1g (Cefotaxime 1g) (Imexpharm Pharmaceutical, product declaration No. VD-26846-17) is an injection or infusion-administrative antibiotic” NCT05804123 ↗ |
| Known as | NSC-756666 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Pretor | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | RU 24756 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Known as | Sodium cefotaxime | ChEMBL registry synonym — accepted as the source's own label CHEMBL1730 ↗ |
| Modality | Small molecule | “3rd Generation Cephalosporin” NCT03922919 ↗ |
| Route | Intravenous | “Cefotaxime is given intravenously” NCT00187655 ↗ |