First use of nitazoxanide in Kelleni’s protocol for managing severe bronchiolitis in a 9-month-old infant: A case report and review of literature

Abstract

BACKGROUND

Lower respiratory tract viral infections are a major cause of mortality in children under five years old, leading to hundreds of thousands of fatalities annually. The highest risk is observed in infants under one year old, underscoring the critical need for safe and effective antiviral protocols.

CASE SUMMARY

A 9-month-old infant suffered from severe bronchiolitis as manifested by high fever (39 °C), decreased appetite, tachypnea, wheezing, and oxygen desaturation (SpO₂ 84% on room air) and was effectively managed at home using Kelleni’s protocol, which includes age-adjusted dose of nitazoxanide (60 mg twice daily), ibuprofen and azithromycin, complemented by selective antihistaminic, antitussive and mucolytic immunomodulatory treatment. The fever resolved, wheezing became more prominent but without respiratory distress, and oxygen saturation gradually increased to 92% by day 10. Nitazoxanide exerts broad antiviral and immunomodulatory effects by enhancing host interferon responses and inhibiting viral replication, potentially attenuating airway inflammation and accelerating resolution of bronchiolitis. The nitazoxanide dose (60 mg twice daily for five days) was carefully adjusted based on the developmental expression and activity of the uridine diphosphate-glucuronosyltransferase 1A1 enzyme, responsible for its metabolism, ensuring safe age-appropriate administration. The infant’s clinical status steadily improved, and by day 14 the infant achieved full recovery with normalization of oxygen saturation (96% on room air). No adverse events occurred, and follow-up at day 28 confirmed sustained recovery.

CONCLUSION

To the best of my knowledge, this report presents, for the first time globally, a potential of nitazoxanide within Kelleni’s protocol to early manage infants younger than one year suffering from severe lower respiratory tract viral infection at home. Selective antitussive treatment, using agents such as low dose benproperine, was employed to mitigate troublesome cough and improve patient comfort without compromising respiratory function. Additionally, alpha amylase was used to facilitate pulmonary secretion clearance. The protocol aims to reduce morbidity and mortality from viral lower respiratory tract infections in this vulnerable population.

Keywords: SARS-CoV-2; COVID-19; Nitazoxanide; Benproperine; Alpha-amylase; Levocetrizine; Ambroxol; Kelleni’s protocol; Case report

Core Tip: This report presents the first documented use of nitazoxanide incorporated within Kelleni’s protocol to manage severe bronchiolitis in a 9-month-old infant. The infant presented with SpO₂ 84% on room air, tachypnea, and diffuse wheezing which was clinically consistent with severe viral bronchiolitis. Bronchiolitis is a leading cause of infant hospitalization and mortality worldwide, with limited effective antiviral treatments. Early administration of nitazoxanide, alongside other immunomodulatory therapies, showed clinical improvement as shown with resolution of fever and progressive improvement in in all symptoms, SpO₂ rising from 84% to 92% and then 96% at full recovery in this severe case within two weeks. This approach highlights the potential to repurpose nitazoxanide and Kelleni’s protocol to safely manage severe lower viral respiratory tract infections in infants younger than one year.