Adults with upper respiratory tract scleroma were more likely to show short-term clinical improvement when they received levofloxacin than when they received third-generation cephalosporins, according to a randomized study from Egypt. Improvement was reported in 80% of the levofloxacin group, compared with 60% of the cephalosporin group, a difference of 20 percentage points. The reported P value was 0.038. No confidence interval for the between-group comparison was reported.
The study enrolled 90 adults at Minia University Hospital between September 2024 and August 2025. Participants were aged 18 to 60 and had upper respiratory tract scleroma confirmed through clinical and histopathological assessment. Clinical improvement was judged from changes in presenting symptoms and clinical signs during clinical and endoscopic follow-up. Because treatment and follow-up covered three months, the results address early response rather than long-term recurrence.
How the comparison was made
Participants were randomly allocated to equal treatment groups using sealed, opaque envelopes, with allocation concealed until after enrollment. Forty-five received levofloxacin and 45 received third-generation cephalosporins. Both antibiotics were administered for three months.
Clinical improvement meant resolution or improvement of the symptoms and clinical signs present at the start of treatment, based on clinical and endoscopic findings during follow-up. The minimum sample size was set at 90 patients, 45 per group, using an assumed Cohen’s h effect size of 0.60, a two-sided significance level of 0.05 and 80% statistical power.
For the predictor analysis, variables with p-values below 0.05 in an initial univariate analysis were entered into a stepwise multivariable binary logistic regression model. The researchers reported adjusted odds ratios and 95% confidence intervals from that model.
Improvement was not uniform
Follow-up comparisons favored levofloxacin for several nasal and smell-related outcomes, pharyngeal findings, voice problems and vocal-fold findings. Other assessed symptoms and laryngeal findings did not show a significant difference between the groups. The paper used P values below 0.05 for results described as significant and did not report an adjustment for the number of comparisons made.
In the multivariable analysis, treatment type and pharyngeal involvement remained significant predictors of clinical improvement. Levofloxacin was associated with higher odds of improvement, with a reported odds ratio of 5.8 and P = 0.015. This is a model-based group estimate, not a guarantee that an individual patient will improve. The supplied analysis also flags apparent formatting anomalies in the displayed regression table, so the exact estimate merits caution.
The predictor findings support the study authors’ interpretation that less extensive disease, particularly the absence of pharyngeal involvement, was more favorable for improvement. Those findings need confirmation in larger studies involving more varied patients and longer follow-up.
The key question is durability
The study cannot show whether the difference between the treatments lasts beyond the three-month follow-up. The authors considered the follow-up too short to assess long-term recurrence, treatment sustainability or relapse rates. The study measured clinical improvement rather than microbiological eradication, and it did not show that levofloxacin was better for every symptom or laryngeal finding.
The evidence came from a single tertiary hospital in a highly endemic region, so its findings may not apply in the same way to other populations or clinical settings. The study’s adult age range and patient selection also limit how broadly the results can be applied.
Longer studies across multiple centers will be needed to test whether the treatment difference persists and whether the reported predictors hold in broader populations. For now, the study offers evidence about short-term clinical improvement in this particular hospital setting, not a final answer about long-term treatment effectiveness.
Study disclosures
The study received ethics approval from the Medical Research Ethics Committee of Minia University under the Declaration of Helsinki. Open-access funding came from the Science, Technology & Innovation Funding Authority in cooperation with the Egyptian Knowledge Bank, and the manuscript reported no commercial financial support or other benefits. The authors declared no competing interests.
The datasets are available from the corresponding author on reasonable request, and no software application or custom code was used. The manuscript records receipt on 3 January 2026 and acceptance on 10 August 2026.
Paper data and sources
Original title: Comparative effectiveness of levofloxacin versus third-generation cephalosporins and predictors of treatment outcomes in upper respiratory tract scleroma: a tertiary center experience.
Authors: Ahmed Ibrahim Khaleel, Rabeh Khairy Saleh, Chrestina Monir Fekry, Fatma Wafik Shahin
Journal/Repository: Scientific reports
Status: Peer-reviewed
First online: 2026-08-20
DOI: 10.1038/s41598-026-66683-y
Original paper · Full text