Trial reportAntimicrobial agents and chemotherapy2004
Tolerability, pharmacokinetics, and serum bactericidal activity of intravenous dalbavancin 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 59 papers.
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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
59 citing papers in PubMed.
- Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients.Antimicrobial agents and chemotherapy · 2020Trial
- Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis.Clinical pharmacology in drug development · 2020Trial
- Production improvement of dalbavancin precursor A40926B0 inSynthetic and systems biotechnology · 2027Article
- Review
- A real-world implementation study of a TDM-guided dalbavancin model for bone and joint infections (101 Dalbatians).JAC-antimicrobial resistance · 2026Article
- Real world use of dalbavancin for bone and joint infections: a retrospective case series in adults and children.BMC research notes · 2026Article
- Negamycin: Nature's Forgotten Antibiotic.ACS infectious diseases · 2026Review
- Experience of use of dalbavancin for the treatment of unlicensed indications in a UK tertiary infectious diseases setting.Infection · 2025Article
- A Comparative Review of the Pharmacology of Dalbavancin and Oritavancin for Gram-Positive Infections: Birds of a Feather or Apples and Oranges?Infectious diseases and therapy · 2025Review
- Article
- Dalbavancin-resistantJAC-antimicrobial resistance · 2024Article
- Successful treatment of MSSA acute bacterial prostatitis using dalbavancin.JAC-antimicrobial resistance · 2024Article
- New Antimicrobials for Gram-Positive Sustained Infections: A Comprehensive Guide for Clinicians.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Staph wars: the antibiotic pipeline strikes back.Microbiology (Reading, England) · 2023Review
- Structure-activity relationships of antibacterial peptides.Microbial biotechnology · 2023Review
- Dalbavancin in clinical practice in Spain: a 2 year retrospective study.JAC-antimicrobial resistance · 2022Article
- Tissue- and cell-expression of druggable host proteins provide insights into repurposing drugs for COVID-19.Clinical and translational science · 2022Review
- Emergence of Dalbavancin, Vancomycin, and Daptomycin Nonsusceptible Staphylococcus aureus in a Patient Treated With Dalbavancin: Case Report and Isolate Characterization.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Recent Advances in the Development of Semisynthetic Glycopeptide Antibiotics: 2014-2022.ACS infectious diseases · 2022Review
- Population Pharmacokinetic and Pharmacodynamic Analysis of Dalbavancin for Long-Term Treatment of Subacute and/or Chronic Infectious Diseases: The Major Role of Therapeutic Drug Monitoring.Antibiotics (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Fifty-two healthy adult male and female volunteers were enrolled in this double-blind study to determine the maximum tolerated dose, characterize the pharmacokinetics, and obtain serum bactericidal activity (SBA) data for intravenous dalbavancin. Subjects were assigned to single- or multiple-dose groups and randomized to receive dalbavancin or placebo intravenously over 30 min. Doses started at 140 mg in the single-dose group and with a 300-mg loading dose (LD), followed by six daily 30-mg maintenance doses (MDs), in the multiple-dose cohort and escalated to a 1120-mg single dose and a 1000-mg LD and 100-mg MD regimen. Plasma, urine, and skin blister fluid aspirate drug concentrations were measured, and pharmacokinetic parameters were determined via noncompartmental methods. SBA against methicillin-resistant Staphylococcus aureus (MRSA) was determined at several time points. Adverse events and changes from the baseline for laboratory data, electrocardiograms, audiologic assessments, physical examinations, and vital signs were assessed. Concentrations increased in proportion to the dose. Steady-state concentrations were achieved by day 3 with the 10:1 LD-MD regimen. The half-life averaged 181 h, and the mean volume of distribution and clearance were 9.75 liters and 0.0473 liters/h, respectively. Mean values were similar in all groups and in males and females. The portion of the dose excreted renally averaged 33.5%. Bactericidal activity was demonstrated in serum at 7 days in all subjects receiving single doses of >or=500 mg. All doses were well tolerated. Dose-limiting toxicity was not encountered. No changes in auditory or vestibular function occurred. The long half-life and maintenance of SBA against MRSA for 1 week suggest that weekly dosing may be feasible.
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