Polichem (Switzerland)

Acute respiratory infections (ARI) still represent a big challenge for paediatricians, especially in those children defined as "ailed" as they are more susceptible to such kinds of disease. In this paediatric population, the immune system is still under-developed with an evident alteration in cytokine levels. A clinical study was carried out in 5 sites in Russia with the intention to enroll children particularly susceptible to contract respiratory infections (defined as "ailing"), assigning them to a treatment group with pidotimod in comparison with a control group, treating them for 30 days and observing the reduction in the number of ARI episodes throughout the follow-up period (6 months). Moreover, changes in serum immunological markers were evaluated at baseline and 30 days after treatment discontinuation. One hundred and fifty-seven ailing children were enrolled and assigned to two arms: a main pidotimod treatment group or a control group. The percentage of incidence of ARIs in the observation period at three different time points was statistically significant (p < 0.05). At the end of the follow-up period (after 6 months), ARIs had developed in 72 children (92.3%) in the main group and in 79 patients (100%) in the control group. Concerning changes of the immunological markers, the treatment group showed a better profile of normalization compared to the control group. The 30-day pidotimod therapy course led to improvement/reduction in the rate of acute respiratory infection recurrence in ailing children within a 3-month period, with a quick elimination of symptoms and signs of infection and, as a result, a faster recovery. The normalisation of the content of the pro-inflammatory cytokine interleukin-8 confirmed the immune-modulatory effect of the investigational drug, underlying its prophylactic effect.

BackgroundBacterial vaginosis (BV) is a polymicrobial infection and the most common cause of vaginal discharge in women during their reproductive years. A randomised, evaluator-blinded, parallel group pivotal study was carried out to assess the efficacy and safety of the local treatment with nifuratel vaginal tablets in comparison with metronidazole vaginal suppositories in premenopausal, non-pregnant women suffering from BV.MethodsA total of 727 adult women in 38 German sites, with BV diagnosed by Amsel and Nugent criteria, were enrolled after providing their written informed consent. Patients received one course of vaginal treatment with metronidazole 100 mg once daily (o.d.) for six days or nifuratel 250 mg o.d. for ten days. The test of cure visit was performed on day 24 ± 3 after the beginning of the treatment. The efficacy was evaluated using the therapeutic cure rate defined as a combined endpoint including Amsel criteria, clinical signs and symptoms and Nugent score evaluated by a blinded central assessor. The non-inferiority of nifuratel compared to metronidazole at the pre-specified margin of Δ-15% was defined as the clinically acceptable difference between the two active treatments.ResultsThe therapeutic cure rate was achieved in the per protocol data set by the 53.7% of women: 54.5% in the nifuratel group and 52.9% in metronidazole treated patients (p = 0.0002). Concerning Nugent score (0–3), the two treatments had similar responder rates: 66.2% nifuratel vs. 66.8% metronidazole (p = 0.0006), same results were obtained in terms of Amsel criteria normalisation 78.9% nifuratel vs. 78.6% metronidazole (p = 0.0001). Nifuratel was slightly better to metronidazole curing vulvovaginal signs and symptoms: 81.2% vs. 78.6% (p < 0.0001).ConclusionThe study results suggest that nifuratel 250 mg vaginal tablet o.d. for 10 days may be recommended as first-line treatment in BV as well as the golden standard metronidazole since their efficacy is comparable.