Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 have evaluated ceftaroline fosamil to assess its dosage, safety, tolerability, and therapeutic efficacy across diverse patient populations. Sponsored by major pharmaceutical entities like Pfizer and Forest Laboratories as well as academic institutions such as Baylor College of Medicine, these studies focus on pharmacokinetic profiles in healthy volunteers alongside bacterial infectious diseases, including community-acquired bacterial pneumonia, MRSA bacteremia, complicated skin and soft tissue infections, osteomyelitis, and pediatric sepsis. While many of these trials are completed, others reflect statuses of active enrollment by invitation, withdrawal, or termination.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT02335905 COMPLETED
Hematogenously Acquired Staphylococcus Aureus Osteomyelitis; Bone Infection; Osteomyelitis
Baylor College of Medicine
 2015-06-03 PHASE1; PHASE2
NCT02424734 TERMINATED
Late-onset Sepsis
Pfizer
 2015-08-04 PHASE2
NCT02806882 COMPLETED
Meningitis; Ventriculitis
Centre Hospitalier Universitaire Dijon
 2015-04-29 PHASE1
NCT02582203 COMPLETED
Skin Diseases, Infectious; Staphylococcal Skin Infections
Wayne State University
 2012-02 PHASE4
NCT02202135 TERMINATED
Complicated Skin and Soft Tissue Infection
Pfizer
 2014-06 PHASE3
NCT01499277 COMPLETED
Complicated Skin and Soft Tissue Infection
Pfizer
 2012-05 PHASE3
NCT01669980 COMPLETED
Infections; Pneumonia
Forest Laboratories
 2012-10 PHASE4
NCT01400867 COMPLETED
Infections, Pediatrics
Forest Laboratories
 2011-12 PHASE2; PHASE3
NCT01701219 COMPLETED
Staphylococcus Aureus Bacteremia; Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
Forest Laboratories
 2013-01 PHASE4
NCT01530763 COMPLETED
Infections; Community Acquired Pneumonia
Forest Laboratories
 2012-09 PHASE2; PHASE3
NCT01645735 COMPLETED
Infections
Forest Laboratories
 2012-10 PHASE4
NCT01664065 COMPLETED
Renal Disease
Pfizer
 2013-02 PHASE1
NCT01666743 WITHDRAWN
Community-Acquired Bacterial Pneumonia (CABP)
Forest Laboratories
 2012-11 PHASE4
NCT01789528 Completed
Pharmacokinetics|Open Label|CAZ-AVI|CXL|Effect on Intestinal Flora|Safety
Pfizer
 2013-08 Phase 1
NCT01605864 COMPLETED
Community Acquired Bacterial Pneumonia
Albany Medical College
 2012-05 PHASE3
NCT01624246 COMPLETED
Augmented Renal Clearance (ARC); Systemic Inflammatory Response Syndrome (SIRS)
Forest Laboratories
 2012-05 PHASE1
NCT01298843 COMPLETED
Infections
Forest Laboratories
 2011-04 PHASE4
NCT01701219 Completed
Staphylococcus Aureus Bacteremia|Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
Forest Laboratories
 2013-01 Phase 4
NCT01666743 Withdrawn
Community-Acquired Bacterial Pneumonia (CABP)
Forest Laboratories
 2012-11 Phase 4
NCT01612507 COMPLETED
Healthy Volunteers
Pfizer
 2012-07 PHASE1
NCT01577589 COMPLETED
Healthy
Pfizer
 2012-04 PHASE1
NCT01612507 Completed
Healthy Volunteers
Pfizer
 2012-07 Phase 1
NCT01458743 COMPLETED
Healthy
Pfizer
 2011-10 PHASE1
NCT01281462 COMPLETED
Urinary Tract Infections
Forest Laboratories
 2010-12 PHASE2
NCT01290900 COMPLETED
Healthy Male Volunteers
Pfizer
 2011-02 PHASE1
NCT00621504 COMPLETED
Bacterial Pneumonia
Forest Laboratories
 2008-01 PHASE3
NCT00509106 COMPLETED
Bacterial Pneumonia
Forest Laboratories
 2007-07 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Ceftaroline Fosamil product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ceftaroline fosamil is converted into its active metabolite ceftaroline, which binds with high affinity to penicillin-binding proteins, particularly PBP2a, thereby blocking bacterial peptidoglycan cross-linking and triggering cell wall lysis. This targeted bactericidal inhibition directly underpins its efficacy in clinical trials targeting community-acquired bacterial pneumonia, methicillin-resistant Staphylococcus aureus bacteremia, and complicated skin and soft tissue infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.