Comparison of safety and efficacy of foam‐based versus solution‐based ciprofloxacin for acute otitis externa
Bibliographic record
Abstract
OBJECTIVE: To compare and evaluate the efficacy and safety of a foam-based antibiotic formulation in the treatment of acute otitis externa (AOE) with the more conventional solution-based formulation. STUDY DESIGN: Phase 2, open-label, randomized controlled trial. SETTING: Multicenter. SUBJECTS AND METHODS: Sixty-three eligible adult patients with unilateral AOE were randomly assigned to one of two treatment groups: an experimental 0.3 percent foam-based ciprofloxacin, (FoamOtic Cipro) or 0.3 percent solution-based ciprofloxacin (Ciloxan). All patients received the same dose regime (twice daily for 7 days). The primary efficacy variable was response to therapy (cure) in the test-of-cure visit. Secondary variables included improvement of the disease symptoms otalgia, tenderness, edema, and otorrhea. RESULTS: Sixty-four patients were enrolled in the study. Seven patients were excluded from the per-protocol analysis due to major deviations from the protocol. Per-protocol analysis (n = 57) showed that cure was achieved in all the patients (P = 1.000). No significant differences were found between groups for symptomatic relief, resolution of otic discharge, or onset of pain reduction. Both treatments were found to be highly efficacious and safe, demonstrating the noninferiority of the experimental drug. CONCLUSION: Foam-based ciprofloxacin is a safe and an effective new treatment for AOE.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".