Ciprofloxacin-fluocinolone combo effective for paediatric otitis media with tympanostomy tubes

Roshini Claire Anthony
29 Dec 2016
Ciprofloxacin-fluocinolone combo effective for paediatric otitis media

A combination of ciprofloxacin and fluocinolone is more effective at treating acute otitis media with tympanostomy tubes (AOMT) in children than either agent alone, according to two recent studies.

In patients receiving the ciprofloxacin-fluocinolone combination, median time to cessation of otorrhoea (the most common complication after tympanostomy tube insertion) was 4.23 days (95 percent confidence interval [CI], 3.65–4.95 days) compared with 6.95 days (95 percent CI, 5.66–8.20 days) in those receiving ciprofloxacin only (p<0.001). Median time to cessation of otorrhoea was not estimable in the fluocinolone group; however, the ciprofloxacin-fluocinolone combination was significantly better than fluocinolone alone (p<0.001). [JAMA Otolaryngol Head Neck Surg 2016;doi:10.1001/jamaoto.2016.3537]

“This difference in favour of ciprofloxacin plus fluocinolone is clinically meaningful because it represents a 64 percent improvement in clinical response and an important advantage over ciprofloxacin as a single-agent antibiotic therapy,” said the authors.

At the final visit, the clinical cure rate (complete resolution of clinical signs that were present at baseline visit) was superior in the ciprofloxacin-fluocinolone combination group (80.6 percent) compared with ciprofloxacin alone (67.4 percent; difference 13.2 percent; p=0.002) or fluocinolone alone (47.6 percent; difference 33.0 percent; p<0.001).

Likewise, the sustained microbiological cure rate (eradication of bacteria at visits 3 and 4) was better in the combination group (79.7 percent) compared with the ciprofloxacin group (67.7 percent; p=0.04) or the fluocinolone group (37.6 percent; p<0.001). However, the microbiological cure rate at the final visit was comparable between the combination (85.7 percent) and ciprofloxacin alone groups (87.1 percent; p=0.86) but not when compared with fluocinolone alone (72.3 percent; p=0.005).

Adverse events related to study drug were similar in the treatment arms (3.1, 3.6, and 4.7 percent of patients receiving ciprofloxacin plus fluocinolone, ciprofloxacin only, and fluocinolone only, respectively), and were mostly mild to moderate.

In these two multicentre, double-blind, identically designed clinical trials conducted between 2011 and 2014, 662 children (median age 2.5 years, n=331 in each trial) with AOMT in at least one ear and moderate or severe purulent otorrhoea for ≤3 weeks were randomized to receive topical ciprofloxacin 0.3% (n=221), fluocinolone acetonide 0.025% (n=218), or both (n=223), twice daily for 7 days. Patients were evaluated at four visits; day 1 (baseline visit), days 3–5 (undergoing therapy visit), days 8–10 (end-of-therapy visit), and days 18–22 (test-of-cure visit).

A previous study found that the combination of ciprofloxacin and dexamethasone was superior to ciprofloxacin alone in children with AOMT, which demonstrated the benefit of adding a corticosteroid to single-agent antibiotic therapy in AOMT treatment. However, there was no significant difference between treatments by day 14 of the study. [Laryngoscope 2003;113:2116-2122]

“Our studies found a significant and consistent benefit of ciprofloxacin plus fluocinolone combination throughout the study period to the test-of-cure visit. This outcome suggests that the addition of fluocinolone to ciprofloxacin may offer a more sustained treatment for AOMT than the addition of dexamethasone,” said the authors of the present studies. 

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