Trial reportAntimicrobial agents and chemotherapy2004
Multiple-dose pharmacokinetics and safety of a novel broad-spectrum cephalosporin (BAL5788) in healthy volunteers.
Trial report in Antimicrobial agents and chemotherapy, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed.
- Review
- Article
- Ceftobiprole medocaril.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022Review
- Model-Based Approach for Optimizing Ceftobiprole Dosage in Pediatric Patients.Antimicrobial agents and chemotherapy · 2021Article
- Pharmacokinetics, pharmacodynamics, and safety of single- and multiple-dose intravenous ceftobiprole in healthy Chinese participants.Annals of translational medicine · 2021Article
- Ceftobiprole: pharmacokinetics and PK/PD profile.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Review
- Safety and tolerability of ceftobiprole.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Review
- Validation and Application of an HPLC-DAD Method for Routine Therapeutic Drug Monitoring of Ceftobiprole.Antimicrobial agents and chemotherapy · 2019Article
- Disposition of ceftobiprole during continuous venous-venous hemodiafiltration (CVVHDF) in a single critically ill patient.European journal of clinical pharmacology · 2018Article
- Pharmacokinetics and Dosing of Ceftobiprole Medocaril for the Treatment of Hospital- and Community-Acquired Pneumonia in Different Patient Populations.Clinical pharmacokinetics · 2016Review
- Ceftobiprole for the treatment of pneumonia: a European perspective.Drug design, development and therapy · 2015Review
- Ceftobiprole medocaril: a review of its use in patients with hospital- or community-acquired pneumonia.Drugs · 2014Review
- Efficacy of ceftobiprole Medocaril against Enterococcus faecalis in a murine urinary tract infection model.Antimicrobial agents and chemotherapy · 2012Article
- In vivo synergism of ceftobiprole and vancomycin against experimental endocarditis due to vancomycin-intermediate Staphylococcus aureus.Antimicrobial agents and chemotherapy · 2011Article
- Resistance and the management of complicated skin and skin structure infections: the role of ceftobiprole.Therapeutics and clinical risk management · 2010Article
- Emerging agents to combat complicated and resistant infections: focus on ceftobiprole.Infection and drug resistance · 2010Article
- Molecular basis and phenotype of methicillin resistance in Staphylococcus aureus and insights into new beta-lactams that meet the challenge.Antimicrobial agents and chemotherapy · 2009Review
- Population pharmacokinetic analysis of ceftobiprole for treatment of complicated skin and skin structure infections.Antimicrobial agents and chemotherapy · 2009Article
- Ceftobiprole, a Broad-Spectrum Cephalosporin With Activity against Methicillin-Resistant Staphylococcus aureus (MRSA).P & T : a peer-reviewed journal for formulary management · 2008Article
- Pharmacokinetics and pharmacodynamics of ceftobiprole, an anti-MRSA cephalosporin with broad-spectrum activity.Clinical pharmacokinetics · 2008Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BAL5788 is the water-soluble prodrug of BAL9141, a novel broad-spectrum cephalosporin with potent bactericidal activity against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae. Safety and pharmacokinetic data from a multiple-dose study with 16 healthy male volunteers are reported. Subjects were randomized to receive BAL5788 at 500 or 750 mg (as BAL9141 equivalents; n = 6 subjects per dose) or placebo (n = 2 subjects per dose). The doses were given as 200-ml infusions over 30 min once daily on days 1 and 8 and twice daily on days 2 to 7. BAL5788 was well tolerated, with no severe or serious adverse events (AEs) or dosing-related changes in laboratory parameters, electrocardiographic findings, or vital signs. Drug accumulation in plasma was negligible during the dosing period. The results of pharmacokinetic analyses agreed well with data reported from a previous single-ascending-dose study. The elimination half-life of BAL9141 was about 3 h. The volume of distribution at steady state was equal to the volume of the adult extracellular water compartment. BAL9141 was predominantly eliminated in urine, and renal clearance of the free drug corresponded to the normal glomerular filtration rate in adults. After multiple infusions of 750 mg, the mean concentrations of BAL9141 in plasma exceeded the MIC at which 100% of MRSA isolates are inhibited (4 microg/ml) for approximately 7 to 9 h, corresponding to 58 to 75% of a 12-h dosing interval.
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