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

Abstract

BACKGROUND:

Antiadhesive compounds are promising candidates for prevention or treatment of infections. We have investigated the efficacy of such an agent, 3'-sialyllacto-N-neotetraose (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 placebo-controlled 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.

• Authors: P Ukkonen, K Varis, M Jernfors, E Herva, J Jokinen, E Ruokokoski, D Zopf, T Kilpi
• Journal: Lancet (London, England) (Lancet) Vol. 356 Issue 9239 Pg. 1398-402 (Oct 21 2000) ISSN: 0140-6736 [Print] England
• PMID: 11052582 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• NE 1530
• Oligosaccharides

Topics

• Acute Disease
• Bacterial Adhesion (drug effects)
• Double-Blind Method
• Female
• Haemophilus influenzae (drug effects, isolation & purification)
• Humans
• Infant
• Male
• Moraxella catarrhalis (drug effects, isolation & purification)
• Nasal Mucosa (drug effects, microbiology)
• Oligosaccharides (therapeutic use)
• Otitis Media (drug therapy, microbiology)
• Streptococcus pneumoniae (drug effects, isolation & purification)