Trial reportAntimicrobial agents and chemotherapy2004
Single-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 27 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
27 citing papers in PubMed, 101 citations in OpenAlex.
- Multiple-dose pharmacokinetics and safety of a novel broad-spectrum cephalosporin (BAL5788) in healthy volunteers.Antimicrobial agents and chemotherapy · 2004Trial
- Treatment of MRSA Infection: Where are We?Current medicinal chemistry · 2024Review
- 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
- Safety and tolerability of ceftobiprole.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Review
- Ceftobiprole: pharmacokinetics and PK/PD profile.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
- 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
- Probability of target attainment for ceftobiprole as derived from a population pharmacokinetic analysis of 150 subjects.Antimicrobial agents and chemotherapy · 2007Article
- Time-kill and synergism studies of ceftobiprole against Enterococcus faecalis, including beta-lactamase-producing and vancomycin-resistant isolates.Antimicrobial agents and chemotherapy · 2007Article
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 2 countries.
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 activities against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae. We investigated the safety and pharmacokinetics of BAL5788 in a double-blind, single-ascending-dose study with 40 healthy male subjects. The subjects were randomized to receive placebo (n = 2 subjects per dose) or BAL5788 (n = 6 subjects per dose) as a 200-ml intravenous infusion over 30 min. The BAL5788 doses used were 125, 250, 500, 750, and 1,000 mg (BAL9141 equivalents). All doses were well tolerated, with no severe or serious adverse events (AEs). The most frequent AE was taste disturbance. No electrocardiographic abnormalities and no trends or clinically significant changes in laboratory parameters or vital signs were observed. The maximum concentration of drug in serum and the area under the concentration-time curve for BAL9141 were dose proportional over the dosing range. 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, and the rate of renal clearance of free drug corresponded to the normal glomerular filtration rate for adults. More than 70% of the administered dose was excreted as BAL9141 in the urine, and almost no prodrug was detected. After the infusion of 750 mg, the mean plasma BAL9141 concentrations exceeded the MIC at which 100% of MRSA isolates are inhibited (4 microg/ml) for approximately 7 h, or 58% of a 12-h dosing interval. These results indicate that infusions of 750 mg twice a day should be adequate for the treatment of infections caused by MRSA.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.