An infant with streptococcal uvulitis presenting with airway obstruction

We report a case of 7-month-old infant girl with severe uvulitis with airway obstruction. Her uvula was erythematous and markedly swollen. Stridor and retraction were noted. The symptoms were resolved after treatment with ampicillin, and a throat swab isolated Group A streptococcus. It is extremely rare in children for uvulitis to cause respiratory distress from airway obstruction. However, in infants with narrow airways, physicians should consider the risk of progression to respiratory distress

Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease

International audienceAbstract In children with congenital heart disease and/or chronic lung disease entering their second respiratory syncytial virus (RSV) season, 200 mg nirsevimab had a similar safety profile to that of palivizumab and resulted in nirsevimab serum exposures associated with efficacy in healthy infants, supporting efficacy in this population at risk of severe RSV disease

Lumicitabine, an orally administered nucleoside analog, in infants hospitalized with respiratory syncytial virus (RSV) infection: Safety, efficacy, and pharmacokinetic results.

Respiratory syncytial virus (RSV) infection is the leading cause of infant hospitalizations and mortality. Lumicitabine, an oral nucleoside analog was studied for the treatment of RSV. The phase 1b and phase 2b studies reported here assessed the safety, pharmacokinetics, and pharmacodynamics of lumicitabine in infants/neonates hospitalized with RSV. In the phase 1b study, infants (≥1 to ≤12 months) and neonates (<28 days) received a single-ascending or multiple-ascending doses (single loading dose [LD] then 9 maintenance doses [MD] of lumicitabine, or placebo [3:1]). In the phase 2b study, infants/children (28 days to ≤36 months old) received lumicitabine 40/20 mg/kg, 60/40 mg/kg LD/MD twice-daily or placebo (1:1:1) for 5 days. Safety, pharmacokinetics, and efficacy parameters were assessed over 28 days. Lumicitabine was associated with a dose-related increase in the incidence and severity of reversible neutropenia. Plasma levels of ALS-008112, the active nucleoside analog, were dose-proportional with comparable mean exposure levels at the highest doses in both studies. There were no significant differences between the lumicitabine groups and placebo in reducing viral load, time to viral non-detectability, and symptom resolution. No emergent resistance-associated substitutions were observed at the RSV L-gene positions of interest. In summary, lumicitabine was associated with a dose-related increase in the incidence and severity of reversible neutropenia and failed to demonstrate antiviral activity in RSV-infected hospitalized infants. This contrasts with the findings of the previous RSV-A adult challenge study where significant antiviral activity was noted, without incidence of neutropenia. Trial registration ClinicalTrials.gov Identifier: NCT02202356 (phase 1b); NCT03333317 (phase 2b)

Fig 4 -

Time to RSV Non-Detectability in MAD Phase (Study 1, Full Analysis Set)–(A) Nasal Aspirates and (B) Nasal Swabs. MAD, multiple-ascending dose; RSV, respiratory syncytial virus. Time to non-detectability was defined as the relative time in hours from the first dose of study drug until the first post-baseline time point when the viral load reached non-detectability. Subjects whose viral load did not reach non-detectability were censored at their last RSV assessment. Time to non-detectability was not defined if a subject did not have any post-baseline viral load result.</p

Demographics and baseline characteristics of Study 1 (ITT Analysis Set).

Demographics and baseline characteristics of Study 1 (ITT Analysis Set).</p

Summary of reported treatment-emergent AEs by treatment groups in Study 1 (Safety analysis set).

Summary of reported treatment-emergent AEs by treatment groups in Study 1 (Safety analysis set).</p

Time from first dose to RSV symptom resolution in MAD phase (Study 1, full analysis set).

MAD, multiple-ascending dose; RSV, respiratory syncytial virus.</p

Summary of clinical parameters and respiratory viruses detected.

Summary of clinical parameters and respiratory viruses detected.</p