Treatment of acute otitis media with an antiadhesive oligosaccharide: a randomised, double-blind, placebo-controlled trial

Autor: David Zopf, Mia Jernfors, Esa Ruokokoski, Pentti Ukkonen, Jukka Jokinen, Herva E, Terhi Kilpi, Kaapo Varis
Rok vydání: 2000
Předmět:
Zdroj: The Lancet. 356:1398-1402
ISSN: 0140-6736
DOI: 10.1016/s0140-6736(00)02843-9
Popis: Summary Background Antiadhesive compounds are promising candidates for prevention or treatment of infections. We have investigated the efficacy of such an agent, 3′-sialyllacto-Nneotetraose (NE-1530), given intranasally for prophylaxis of acute otitis media and for effect on nasopharyngeal carriage of bacteria. Methods We did a randomised, double-blind placebocontrolled study at one study site. 507 healthy children were randomly assigned either NE-1530 (n=254) or placebo (253) as intranasal sprays twice daily during 3 months. The children were examined by the study physicians once a month and during illness. Treatment efficacy was estimated from Cox proportional hazards model. A sample of nasopharyngeal secretion was taken at every visit for culture of Streptococcus pneumoniae, Haemophilus influenzae , and Moraxella catarrhalis. Adverse events were recorded in study diaries. Findings At least one event of acute otitis media was diagnosed in 108 (43%) of 254 children in the NE-1530 group and in 86 (34%) of 253 children in the placebo group. The efficacy of treatment was negative, −27% (95% CI −68 to 5; p=0·10). The nasopharyngeal carriage of S pneumoniae, H influenzae , and M catarrhalis was not affected by treatment, and the adverse event profiles were almost identical for NE-1530 and placebo. Interpretation NE-1530 did not have a beneficial effect on the occurrence of acute otitis media or on the nasopharyngeal carriage of bacteria in children.
Databáze: OpenAIRE
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