Double-blind, multi-centre trial to compare a once-daily combination of trimethoprim and sulfamethopyrazine with ampicillin 4-times daily in patients with urinary infections.

Sixty-eight patients with urinary infection were allocated at random to receive treatment with either 500 mg ampicillin 4-times daily or a trimethoprim (250 mg)/sulfamethopyrazine (200 mg) combination given once daily after a double, loading dose on the first day. All patients complained of urinary symptoms and showed significant bacteriuria, E. coli being the pathogen most frequently recovered. Clinical and microbiological assessments were carried out on entry and, as a rule, after 3 to 4 days and 1 to 2 weeks of treatment. In the 35 patients receiving trimethoprim/sulfamethopyrazine, 40 (95%) of the 42 original infecting organisms were eradicated. In the 33 patients on ampicillin, the eradication rate was 32 (89%) out of 36 organisms. The course of urinary symptoms was similarly favourable in the two groups. Overall response was considered as 'excellent' or 'good' in 89% of the patients receiving the combination preparation and in 82% of those given ampicillin. Clinical and biological tolerance was satisfactory under both regimens. A longer follow-up control should confirm the value of the new combination in the treatment of urinary infections.

Clinical assessment of a trimethoprim-sulfamethopyrazine combination (Kelfiprim) in lower respiratory tract infections.

The new combination of trimethoprim 250 mg and sulfamethopyrazine 200 mg was used in fourteen out-patients and eighteen in-patients with acute exacerbation of chronic bronchitis, pneumonia or bronchopneumonia due to sensitive bacteria. The drug was given for 1 to 2 weeks as one capsule daily (following a double loading dose on the first day), and ampicillin, 500 mg capsules q.i.d., was administered to another group of eleven in-patients for comparison. Overall results, based on clinical, radiological and laboratory findings, were excellent or good in 85% and 67%, respectively, of out- and in-patients receiving the combination drug; definite failures were one out of fourteen and two out of eighteen cases, and the remainder were assessed as fair. In three out of thirty-two patients mild to moderate gastro-intestinal side-effects were observed during treatment. The drug compared favourably to ampicillin for both effectiveness and safety.