Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01984684 (A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections), which is not on this map. Cited by 47 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.
A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Who cites it
47 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- Pooled it
- The efficacy and adverse events of delafloxacin in the treatment of acute bacterial infections: A systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2022Pooled it
- Comparative efficacy of delafloxacin for complicated and acute bacterial skin and skin structure infections: results from a network meta-analysis.BMC infectious diseases · 2021Pooled it
- A Randomized, Observer-Blinded, Active-Controlled, Phase IIIb Study to Compare IV/Oral Delafloxacin Fixed-Dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections: The DRESS Study.Open forum infectious diseases · 2025Trial
- Pharmacokinetics and pharmacodynamics of intravenous delafloxacin in healthy subjects: model-based dose optimization.Antimicrobial agents and chemotherapy · 2024Trial
- Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid.Antimicrobial agents and chemotherapy · 2020Trial
- Analysis of Pooled Phase III Efficacy Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Analysis of Pooled Phase 3 Safety Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Evaluation of in vitro activity of delafloxacin against Staphylococcus aureus MSSA and MRSA isolated from a Brazilian tertiary hospital.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2026Article
- ASP-COMPLEX: redefining antimicrobial stewardship to improve outcomes in high-risk patients with severe infections.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Review
- Delafloxacin: what does a new fluoroquinolone offer?Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Review
- The Next Frontier: Unveiling Novel Approaches for Combating Multidrug-Resistant Bacteria.Pharmaceutical research · 2025Review
- The future approach for the management of acute bacterial skin and skin structure infections.Current opinion in infectious diseases · 2025Review
- Review
- Prevention and Modern Strategies for Managing Methicillin-Resistant Staphylococcal Infections in Prosthetic Joint Infections (PJIs).Antibiotics (Basel, Switzerland) · 2024Review
- 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
- Exploration of a Potential Desirability of Outcome Ranking Endpoint for Complicated Intra-Abdominal Infections Using 9 Registrational Trials for Antibacterial Drugs.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Updated Review on Clinically-Relevant Properties of Delafloxacin.Antibiotics (Basel, Switzerland) · 2023Review
- Prevalence, antimicrobial susceptibility pattern and multidrug resistance of methicillin-resistantBMJ open · 2023Observational
Corrections and comments
- Commented on by
Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Delafloxacin is an intravenous (IV)/oral anionic fluoroquinolone with activity against gram-positive (including methicillin-resistant Staphylococcus aureus [MRSA]), gram-negative, atypical, and anaerobic organisms. It is approved in the United States for acute bacterial skin and skin structure infections (ABSSSIs) caused by designated susceptible gram-positive and gram-negative organisms, and is in development for the treatment of community-acquired bacterial pneumonia. Methods: A multicenter, randomized, double-blind trial of 850 adults with ABSSSI compared delafloxacin 300 mg IV every 12 hours for 3 days with a switch to 450 mg oral delafloxacin, to vancomycin 15 mg/kg IV with aztreonam for 5-14 days. The primary endpoint was objective response at 48-72 hours. Investigator-assessed response based on resolution of signs and symptoms at follow-up (day 14 ± 1), and late follow-up (day 21-28) were secondary endpoints. Results: In the intent-to-treat analysis set, the objective response was 83.7% in the delafloxacin arm and 80.6% in the comparator arm. Investigator-assessed success was similar at follow-up (87.2% vs 84.4%) and late follow-up (83.5% vs 82.2%). Delafloxacin was comparable to vancomycin + aztreonam in eradication of MRSA at 96.0% vs 97.0% at follow-up. Frequency of treatment-emergent adverse events between the groups was similar. Treatment-emergent adverse events leading to study drug discontinuation was higher in the vancomycin + aztreonam group (1.2% vs 2.4%). Conclusions: In ABSSSI patients, IV/oral delafloxacin monotherapy was noninferior to IV vancomycin + aztreonam combination therapy for both the objective response and the investigator-assessed response at follow-up and late follow-up. Delafloxacin was well tolerated as monotherapy in treatment of ABSSSIs. Clinical Trials Registration: NCT01984684.
Indexed as
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What OpenQuestion holds
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.