Trial reportAntimicrobial agents and chemotherapy2013
Phase II clinical study of BC-3781, a pleuromutilin antibiotic, in treatment of patients with acute bacterial skin and skin structure infections.
Trial report in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- Pooled it
- Pooled it
- Managing community acquired pneumonia in the elderly - the next generation of pharmacotherapy on the horizon.Expert opinion on pharmacotherapy · 2017Pooled it
- Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.The Journal of antimicrobial chemotherapy · 2019Trial
- Review
- Synthesis and Antibacterial Activity of Alkylamine-Linked Pleuromutilin Derivatives.Antibiotics (Basel, Switzerland) · 2024Article
- In Vivo Immune-Modulatory Activity of Lefamulin in an Influenza Virus A (H1N1) Infection Model in Mice.International journal of molecular sciences · 2024Article
- Target attainment of intravenous lefamulin for treatment of acute bacterial skin and skin structure infections.The Journal of antimicrobial chemotherapy · 2024Article
- Pharmacokinetic, Pharmacokinetic/Pharmacodynamic, and Safety Investigations of Lefamulin in Healthy Chinese Subjects.Antibiotics (Basel, Switzerland) · 2023Article
- Insufficient Representation of Patients With Obesity in Randomized Controlled Trials Evaluating the Efficacy and Safety of Antimicrobials for Treatment of Skin and Skin Structure Infections: A Scoping Review.Open forum infectious diseases · 2023Article
- Lefamulin.Hospital pharmacy · 2022Article
- Lefamulin: a New Hope in the Field of Community-Acquired Bacterial Pneumonia.Current pharmacology reports · 2022Review
- Ten decadal advances in fungal biology leading towards human well-being.Fungal diversity · 2022Review
- Emerging Treatment Options for Acute Bacterial Skin and Skin Structure Infections and Bloodstream Infections Caused byInfection and drug resistance · 2022Review
- Pharmacodynamic evaluation of lefamulin in the treatment of gonorrhea using a hollow fiber infection model simulatingFrontiers in pharmacology · 2022Article
- Overview of Changes to the Clinical and Laboratory Standards InstituteJournal of clinical microbiology · 2021Review
- Clinical Pharmacokinetics and Pharmacodynamics of Lefamulin.Clinical pharmacokinetics · 2021Review
- Treatment of methicillin-resistantJAC-antimicrobial resistance · 2021Review
- Treatment of Community-Acquired Pneumonia: A Focus on Lefamulin.Infectious diseases and therapy · 2021Review
- Review
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 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study investigated the potential of the novel systemic pleuromutilin antibiotic BC-3781 to treat patients with an acute bacterial skin and skin structure infection (ABSSSI) caused by a Gram-positive pathogen. Patients were randomized to intravenous BC-3781 100 mg, BC-3781 150 mg, or vancomycin 1 g every 12 h. Response to treatment was assessed daily and at test of cure (TOC). The primary endpoint was the clinical success rate at TOC in the modified intent-to-treat (MITT) and clinically evaluable (CE) analysis populations. Baseline characteristics, including the frequency of methicillin-resistant Staphylococcus aureus (MRSA), were comparable between the different treatment groups. Of 210 patients randomized, 186 (88.6%) patients completed the study. Clinical success at TOC in the CE population occurred in 54 (90.0%) patients in the BC-3781 100-mg group, 48 (88.9%) in the BC-3781 150-mg group, and 47 (92.2%) in the vancomycin group. At day 3, the clinical response rate was similar across the three treatment groups. Six patients discontinued study medication following an adverse event. The incidence rate for drug-related adverse events was lower for patients receiving BC-3781 (34.3% and 39.4% in the 100-mg and 150-mg groups, respectively) than those receiving vancomycin (53.0%). When BC-3781 was used to treat ABSSSIs caused by a Gram-positive pathogen, including MRSA, clinical success rates were comparable to those of the comparator, vancomycin. BC-3781 was generally well tolerated. These results provide the first proof of concept for the systemic use of a pleuromutilin antibiotic for the treatment of ABSSSIs.
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Registered trials
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.