We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Treatment of pulmonary mucormycosis with adjunctive nebulized amphotericin B (MUCONAB trial): Results of an open‐label randomized controlled trial.
- Authors
Muthu, Valliappan; Gogineni, Ratnakara Rao; Agarwal, Ritesh; Prasad, Kuruswamy Thurai; Sehgal, Inderpaul Singh; Dhooria, Sahajal; Aggarwal, Ashutosh N.; Rudramurthy, Shivaprakash Mandya; Singh, Harkant; Garg, Mandeep; Chakrabarti, Arunaloke
- Abstract
Background: The role of nebulized amphotericin B (NAB) in managing pulmonary mucormycosis (PM) is unknown. Methods: In this open‐label trial, we randomized PM subjects to receive either intravenous liposomal amphotericin B (control arm, 3–5 mg/kg/day) alone or along with nebulized amphotericin B deoxycholate (NAB, 10 mg twice a day, every alternate day). The primary outcomes were: (1) overall response ('success' [complete or partial response] or 'failure' [stable disease, progressive disease, or death]) at 6 weeks; and (2) the proportion of subjects with adverse events (AE). The key secondary outcome was 90‐day mortality. We performed a modified intention‐to‐treat (mITT) analysis where we included only subjects receiving at least a single dose of NAB. Results: Fifteen and 17 subjects were randomized to the control and NAB arms; two died before the first dose of NAB. Finally, we included 30 subjects (15 in each arm; mean age 49.8 years; 80% men) for the mITT analysis. Diabetes mellitus (n = 27; 16/27 were COVID‐19‐associated PM) was the most common predisposing factor. The overall treatment success was not significantly different between the control and the NAB arms (71.4% vs. 53.3%; p =.45). Twenty‐nine subjects experienced any AE, but none discontinued treatment. The 90‐day mortality was not significantly different between the control (28.6%) and NAB arm (53.3%; p =.26). Conclusion: Adjunctive NAB was safe but did not improve overall response at 6 weeks. A different dosing schedule or nebulized liposomal amphotericin B may still need evaluation. More research is needed to explore other treatment options for PM.
- Subjects
AMPHOTERICIN B; RANDOMIZED controlled trials; MUCORMYCOSIS
- Publication
Mycoses, 2023, Vol 66, Issue 8, p688
- ISSN
0933-7407
- Publication type
Article
- DOI
10.1111/myc.13591