ArticleOpen forum infectious diseases2020
A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP).
Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03534622 (A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
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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.
A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- 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
- Clinical applications of mesenchymal stromal cell-based therapies for pulmonary diseases: An Update and Concise Review.International journal of medical sciences · 2021Pooled it
- Managing community acquired pneumonia in the elderly - the next generation of pharmacotherapy on the horizon.Expert opinion on pharmacotherapy · 2017Pooled it
- Etiology and efficacy of anti-microbial treatment for community-acquired pneumonia in adults requiring hospital admission in Ukraine.Acta bio-medica : Atenei Parmensis · 2022Trial
- Some Newer Antibiotics Active AgainstAntibiotics (Basel, Switzerland) · 2026Review
- Challenges and opportunities in the management of severe pneumonia. Key concepts from the Seventh Annual Meeting of Spanish Experts 2025.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
- Omadacycline Pharmacokinetics: Characteristics, Contributing Factors, and Clinical Significance.Drugs in R&D · 2025Review
- Nafithromycin in CABP: promise and precaution-authors' reply.The Lancet regional health. Southeast Asia · 2025Article
- Efficacy and safety of a 3-day once-daily regimen of oral nafithromycin in comparison to oral moxifloxacin for the treatment of community-acquired bacterial pneumonia in adults: a phase III, randomized, double-blind controlled trial.The Lancet regional health. Southeast Asia · 2025Article
- Towards a holistic approach to pulmonary infections. Insights from the Sixth Annual Meeting of Spanish Experts 2024.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025Review
- Using delafloxacin, a 4th generation fluoroquinolone, in combination with nebulised tobramycin to eradicateRespiratory medicine case reports · 2025Article
- Guidelines for Antibiotics Prescription in Critically Ill Patients.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024Article
- Advancements in the Management of Severe Community-Acquired Pneumonia: A Comprehensive Narrative Review.Cureus · 2023Review
- New Antimicrobials for Gram-Positive Sustained Infections: A Comprehensive Guide for Clinicians.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Updated Review on Clinically-Relevant Properties of Delafloxacin.Antibiotics (Basel, Switzerland) · 2023Review
- Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?Pharmaceutics · 2023Review
- Antibiotics in the pipeline: a literature review (2017-2020).Infection · 2022Review
- Review
- Urgent need for novel antibiotics in Republic of Korea to combat multidrug-resistant bacteria.The Korean journal of internal medicine · 2022Review
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe clinical and economic burden of community-acquired bacterial pneumonia (CABP) is significant and is anticipated to increase as the population ages and pathogens become more resistant. Delafloxacin is a fluoroquinolone antibiotic approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections. Delafloxacin's shape and charge profile uniquely impact its spectrum of activity and side effect profile. This phase 3 study compared the efficacy and safety of delafloxacin with moxifloxacin for the treatment of CABP.
methodsA randomized, double-blind, comparator-controlled, multicenter, global phase 3 study compared the efficacy and safety of delafloxacin 300 mg twice daily or moxifloxacin 400 mg once daily in adults with CABP. The primary end point was early clinical response (ECR), defined as improvement at 96 (±24) hours after the first dose of study drug. Clinical response at test of cure (TOC) and microbiologic response were also assessed.
resultsIn the intent-to-treat analysis population (ITT), ECR rates were 88.9% in the delafloxacin group and 89.0% in the moxifloxacin group. Noninferiority of delafloxacin compared with moxifloxacin was demonstrated. At TOC in the ITT population, the success rates were similar between groups. Treatment-emergent adverse events that were considered at least possibly related to the study drug occurred in 65 subjects (15.2%) in the delafloxacin group and 54 (12.6%) in the moxifloxacin group.
conclusionsIntravenous/oral delafloxacin monotherapy is effective and well tolerated in the treatment of adults with CABP, providing coverage for Gram-positive, Gram-negative, and atypical pathogens. CLINICALTRIALSGOV IDENTIFIER: NCT03534622.
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