Issue: July 2010
July 01, 2010
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Topical antibiotic rapidly effective, easy to use in children with bacterial conjunctivitis

A study showed a faster cure rate for azithromycin by day 3 of treatment.

Issue: July 2010
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Azithromycin 1.5% eye drops lead to a more rapid clinical and microbiological treatment of bacterial conjunctivitis in pediatric patients than other topical antibiotics, according to a multicenter European study.

In addition, the study posits that azithromycin’s innovative twice-a-day dosing regimen over 3 days is easier to follow and therefore leads to better compliance.

Purulent bacterial conjunctivitis is a common disease in childhood, affecting one in eight children each year. Cases are often isolated, but epidemic spreads can occur in closed environments such as nurseries and schools.

“Current topical antibiotics require frequent instillations. Compliance is generally poor, and the treatment is often discontinued as soon as the external signs of the infection disappear, before complete recovery. With an improper regimen, the risks of reinfection, bacterial resistance and infection spread are high,” said Dominique Brémond-Gignac, MD, PhD, a professor in pediatric ophthalmology at the University of Amiens, France.

A topical antibiotic that treats the infection more rapidly with a reduced number of instillations is particularly suitable for children, she said.

Earlier efficacy

In a randomized, multicenter study of 1,043 adults and children, the efficacy and safety of Azyter (azithromycin 1.5%, Laboratoires Théa) and tobramycin drops were evaluated in 150 pediatric patients between the ages of 4 days and 17 years.

“Azithromycin was administered in one group of randomly selected children as a single drop twice a day for 3 days. Tobramycin was instilled, as recommended, every 2 hours during the day, up to eight times per day for 2 days, then four times a day for 5 days,” Dr. Brémond-Gignac explained.

Clinical and microbiological evaluations were carried out at day 0, day 3 and day 9. Considering the small number of patients in the two groups, statistical analysis using the bootstrap re-sampling technique was carried out.

At day 9, results in the two groups were comparable: Approximately 80% of the children were clinically cured, and about 90% were microbiologically cured. However, at day 3, results differed.

“Clinical cure was achieved in 48% of the children in the azithromycin group and 27% in the tobramycin group. The rate of microbiological cure was 94% vs. 76%. The difference was statistically significant,” Dr. Brémond-Gignac said.

This was shown by the bootstrap analysis with a significant difference between the two treatments at day 3.

“This comparison showed very clearly that azithromycin is effective earlier and after a significantly lower number of instillations,” she said.

Microbiological analysis also showed that some common pathogens of infectious conjunctivitis, such as Haemophilus influenzae, were neutralized at day 9 by azithromycin but not by tobramycin. Other bacteria known to be naturally resistant to systemic azithromycin, such as Acinetobacter and Pseudomonas, were killed by the topical azithromycin eye drops.

Azithromycin was also proven to be safe and well-tolerated by all children, including newborns. No treatment-related systemic or ocular adverse events or symptoms were observed. – by Michela Cimberle

  • Dominique Brémond-Gignac, MD, PhD, can be reached at University Hospital of Amiens, Ophthalmology Department, Centre St. Victor, 354 Bd. de Beauvillé, 80054 Amiens Cedex, France; +33-322824108; fax: +33-322824061; e-mail: bremond.dominique@chu-amiens.fr. Dr. Brémond-Gignac is a paid consultant for Laboratoires Théa but has no financial interest in Azyter.