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The primary objective of the study was to evaluate the taste of two formulations of phenoxymethylpenicillin suspension in children. The two suspensions, designated Test and Standard, differed only in their flavouring and sweetening agents. The secondary objectives were to study age-related differences in taste perception, to evaluate the acceptability of the suspensions, and to determine patient compliance. In 319 children with acute otitis media a taste description was recorded after a single therapeutic dose. The patient's own spontaneous verbal judgements, directly after the dose intake and also 3-4 minutes later, were recorded. The parents were asked about the child's acceptance of the suspension after finalized treatment. For 214 patients compliance was calculated from the remaining amount of suspension in the returned medication bottles. The study indicated that children aged 6 years or older considered the test formulation to be better-tasting than the standard formulation. The judgements by the parents also indicated that the test suspension was more acceptable. In children below 6 years there was no significant difference between the two suspensions with regard to taste or acceptance. A high patient compliance (greater than or equal to 90%) was obtained in 88% of the patients.

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A double-blind, randomized, placebo-controlled clinical trial was conducted to evaluate one month of amoxicillin-clavulanate potassium treatment of children with secretory otitis media. In total, 264 children, aged 1 to 10 years, were randomly assigned to either antibiotic or placebo treatment; 43 patients were excluded during treatment, equally distributed in both groups, leaving 221 patients completing the trial. The inclusion criterion was a type C2 and type B tympanometry result of at least three months' duration. Tympanometry was performed every month for 12 additional months. At the end of the treatment period, the disease was reversed in 61% in the antibiotic-treated group compared with 30% in the placebo-treated group (P less than .0001), and the improvement was persistently significant in favor of antibiotic for eight months. The effect was present in all age groups and independent of laterality of disease. The middle-ear status at the end of treatment was the determining factor for the outcome of tympanometry the year following treatment. From the end of treatment, there was no difference between tympanometry in a patient having been treated with the antibiotic and a patient having been treated with placebo. Antibiotic treatment shifts the individual patient from poor to better tympanometric conditions, so antibiotics can be recommended in the treatment of secretory otitis media before inserting ventilating tubes.

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A total of 97 children with acute otitis media were entered into a single-blind, parallel-group study to compare the efficacy and tolerance of suspensions of bacampicillin, given twice daily, with amoxycillin, given three times daily. The daily dosage was about 40 mg/kg body weight in each case and the duration of treatment was 10 days. Patients were examined before the start of treatment, at an early follow-up visit within 2-3 weeks after the start of treatment and at a late follow-up visit 4-6 weeks after the start of treatment. The initial bacteriology revealed a relatively high proportion of Branhamella catarrhalis and a low incidence of pneumococci. In total, 92 patients were evaluated for efficacy at early follow-up, where both bacampicillin and amoxycillin showed equal and good treatment results in approximately 90% of cases. Evaluation at the last valid visit showed that 80-90% of the patients were either cured or improved. The failure frequency tended to be somewhat higher with amoxycillin.

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Clinical and bacteriological studies were performed in 122 children, aged 1-10 years, with recurrent otitis media or failed therapy with phenoxymethyl penicillin. A specimen for bacteriological culture was taken from the nasopharynx in all patients, and in our material Haemophilus influenzae, Branhamella catarrhalis and Streptococcus pneumoniae were equally distributed, each forming one-third of the total bacterial count. Thus, H. influenzae and B. catarrhalis (as well as their betalactamase-producing strains) were found more frequently than is generally reported for acute otitis media. Treatment with amoxycillin/clavulanate (Spektramox) gave a high and satisfactory effect comparable to the treatment result of cefaclor (Kefolor). The eradication of the initial pathogens was achieved to a significantly higher extent with Spektramox than with Kefolor. Both drugs were well tolerated.

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71 children and adults (median age 7 years) with chronic obstructive pulmonary disease in which ampicillin-sensitive Haemophilus influenzae were isolated from lower airway secretions were included in a single-blind study comparing amoxycillin/clavulanate and amoxycillin alone. The dosage of amoxycillin was 50 mg/kg/day given together with probenecid and divided in 3 doses. Duration of treatment was 14 days. Clinical and bacteriological examinations were performed at study entry and again immediately after the treatment period. A late bacteriological follow-up 1.5 months after entry was performed. 65 patients were eligible for analysis of clinical outcome, and no difference between the groups was found. Side-effects were mild at a frequency of 3% for either preparation. In terms of eradication of the initially isolated H. influenzae amoxycillin/clavulanate tended to be better than amoxycillin, although the difference was not significant (70% and 57%, respectively). In a subset of 33 patients with polymicrobial flora amoxycillin/clavulanate was significantly more effective than amoxycillin. However, amoxycillin/clavulanate did not significantly reduce the emergency of beta-lactamase producing H. influenzae during treatment, and thus offers no advantage over amoxycillin in patients with amoxycillin-sensitive H. influenzae. The combination should be reserved to patients with either polymicrobial flora or ampicillin-resistant H. influenzae.

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The two KDO analogues 2,6-anhydro-3-deoxy-D-glycero-D-galacto-octonate and 2,6-anhydro-3-deoxy-D-glycero-D-talo-octonate were synthesized and tested as inhibitors of the enzyme CTP:CMP-deoxyoctulosonate cytidylyltransferase (CMP-KDO synthetase) from Gram-negative bacteria. Only compound 4, the 2-deoxy analogue of beta-KDO-pyranose, was found to be an inhibitor with a Ki of 3.9 microM.

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