ArticleThe Lancet regional health. Southeast Asia2025
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.
Article in The Lancet regional health. Southeast Asia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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.
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Who cites it
3 citing papers in PubMed.
- Antibiotic development and a path to access in India.Nature communications · 2026Article
- Nafithromycin in CABP: promise and precaution.The Lancet regional health. Southeast Asia · 2025Article
- Nafithromycin in CABP: promise and precaution-authors' reply.The Lancet regional health. Southeast Asia · 2025Article
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14 authors.
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Abstract
Background: Nafithromycin, a novel macrolide belonging to the lactone ketolide subclass, exhibits excellent Methods: This was a phase III, randomized, double-blind, non-inferiority study in adults with CABP (PORT risk class II, III, IV), conducted at 31 sites across India. Patients were randomized (1:1) via block randomisation using interactive voice/web response system to receive oral nafithromycin 800 mg q24h for 3 days or oral moxifloxacin 400 mg q24h for 7 days. The primary efficacy endpoint was the proportion of patients with early clinical response (ECR) at Day 4 in the modified-intent-to-treat population (MITT). Favourable ECR was defined as alive and ≥1 level improvement in ≥2 CABP symptoms compared to baseline and without worsening of other CABP symptoms. A non-inferiority margin of 12.5% was utilised. This trial is registered with Clinical Trial Registry-India (CTRI/2019/11/021964). Findings: Between February 2021 and June 2023, 488 patients were enrolled with 244 randomized to each treatment. MITT population included 477 patients with 40% belonging to PORT risk class III/IV. Demography and baseline characteristics were comparable between groups. ECR was observed in 91.3% (220/241) of patients in nafithromycin group and 89.0% (210/236) of patients in moxifloxacin group of the MITT population [difference, 2.3%; 95% CI (-3.1, 7.8)] establishing statistical non-inferiority between treatments. Most common treatment-emergent adverse events reported (≥2% patients in any treatment group) were abdominal pain, diarrhoea, headache and nausea, which were all mild in severity. Interpretation: A 3-day regimen of oral nafithromycin was non-inferior to a 7-day regimen of oral moxifloxacin for the treatment of CABP. Funding: Co-funded by Wockhardt and BIRAC, Department of Biotechnology, Government of India.
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