Effectiveness and Pharmacokinetic evaluation of Geonistin® (Oxytetracyline and Nystatin) Vaginal Tablets for Unspecific and Mixed Vulvovaginal Infections (GENIE Study).

The GENIE study was performed to evaluate the effectiveness and systemic exposure to oxytetracycline in local treatment of unspecific and mixed vulvovaginal infections characterized by vaginal discharge with Geonistin® vaginal tablets (100 mg oxytetracycline and 100 000 IU nystatin). The total number of subjects enrolled was 189. The treatment had beneficial effects in 100% of the study population. According to the Nugent score, the treatment had a positive effect in 89.2% of participants. The microbiological cure rate was 78.8%. Oxytetracycline concentration levels were from 13.3 to 32.2 ng/mL in 11 out of 15 subjects, and in four subjects the levels were below 10 ng/mL. Geonistin® had a beneficial effect on the unspecific and mixed vulvovaginal infections characterized by vaginal discharge in all efficacy and safety outcomes. Microbiological and the Nugent score efficacy measures confirmed clinical effectiveness. Beneficial efficacy results were achieved with only a few non-serious adverse events.

SAFETY AND EFFECTIVENESS OF AZITHROMYCIN IN THE TREATMENT OF LOWER RESPIRATORY INFECTIONS: AN INTERNATIONAL, MULTICENTER, NON-COMPARATIVE STUDY.

The aim of this study was to describe clinical effectiveness of azithromycin in the management of lower respiratory tract infections in daily clinical practice, to examine duration of symptoms after therapy initiation, and to record any possible adverse effects of azithromycin treatment. A total of 153 patients were included in the analysis of the effectiveness of azithromycin: 94 patients with community acquired pneumonia (CAP) and 59 with acute exacerbation of chronic bronchitis (AECB). Clinical effectiveness was assessed as improvement, cure or failure after three-day treatment with azithromycin. The assessment was based on a calculation of clinical score for each diagnosis before treatment and on days 4, 10 and 28 after treatment initiation. Clinical effectiveness of azithromycin was 93.6% in CAP group and 94.9% in AECB group. Azithromycin led to relief of symptoms within three days in 88.6% of CAP patients and 77.2% of AECB patients. Overall, 15 adverse events were reported in 14 (9.1%) patients. The most common adverse events were abdominal pain, diarrhea and vomiting, each reported in four (2.6%) patients. Accordingly, azithromycin was found to have high clinical effectiveness and a small number of adverse events in the treatment of lower respiratory tract infections. ISRCTN38391551.