SynthesisClinical pharmacokinetics2005
Pharmacodynamic analysis of the microbiological efficacy of telithromycin in patients with community-acquired pneumonia.
Synthesis in Clinical pharmacokinetics, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed, 11 citations in OpenAlex.
- Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.Antimicrobial agents and chemotherapy · 2018Article
- Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.Antimicrobial agents and chemotherapy · 2016Article
- Telithromycin in the treatment of acute bacterial sinusitis, acute exacerbations of chronic bronchitis, and community-acquired pneumonia.Therapeutics and clinical risk management · 2006Article
- Clinical pharmacokinetics of telithromycin, the first ketolide antibacterial.Clinical pharmacokinetics · 2005Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveTelithromycin, a ketolide antibacterial, demonstrates concentration-dependent bactericidal activity against the major pathogens causing community-acquired respiratory tract infections. The objective of this study was to explore the relationships between pharmacokinetic/pharmacodynamic predictor variables, such as area under the plasma concentration-time curve (AUC) over minimum inhibitory concentration (MIC) [AUC/MIC], maximum plasma concentration (C(max)) over MIC (C(max)/MIC) and microbiological outcome from telithromycin therapy for community-acquired pneumonia (CAP). PATIENTS AND
methodsData were pooled from five phase III studies of oral telithromycin (800 mg once daily for 7-10 days) for the outpatient treatment of adults with CAP. Only subjects with a single pathogen isolated at baseline, a telithromycin MIC determination and at least one plasma pharmacokinetic sample were included. Bacteriologically modified intent-to-treat (bmITT) and bacteriologically evaluable per protocol (PPb) populations were analysed. Individual AUC and C(max) Bayesian estimates were obtained with a population pharmacokinetic model. Logistic regression, nonparametric smoothing, and classification analysis and regression tree (CART) were used to assess the relationship between AUC/MIC and C(max)/MIC and microbiological outcome by pathogen.
resultsThe bmITT population included 224 patients (Streptococcus pneumoniae in 113, Haemophilus influenzae in 89 and Staphylococcus aureus in 22). Median telithromycin MIC was 0.015 microg/mL for S. pneumoniae, 2.0 microg/mL for H. influenzae and 0.12 microg/mL for S. aureus, with median AUC/MIC of 907.1, 6.9 and 98.4, and median C(max)/MIC of 172.0, 1.3 and 20.4 for the three pathogens, respectively. Both logistic regression and nonparametric smoothing showed the probability of microbiological cure to be consistently greater than 90% over the observed range of predictor variables. No reliable AUC/MIC or C(max)/MIC breakpoints were identified by CART.
conclusionTelithromycin exhibits near-maximal efficacy against three major pathogens causing CAP at a dose of 800 mg once daily.
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