trimethoprim--sulfamethoxazole-drug-combination and kelfiprim

Kelfiprim (KP) is a new bactericidal agent containing trimethoprim (T) and sulfametopyrazine (S), a long-acting sulfonamide (ratio 5:4). The posology is one capsule (T 250 mg + S 200 mg) daily, after a loading dose of two capsules on the first day. To evaluate the clinical value of Kelfiprim (KP) vs co-trimoxazole (CO) in urinary tract infection (UTI) a controlled multicenter double-blind trial (MDBT) was carried out in 76 patients suffering from persistent and recurrent UTIs. About 90 per cent response rate (sterile urine at the end of treatment) was obtained for KP and about 85 per cent for CO in recurrent UTI. In persistent UTI the rate of recovery was 66.8 per cent and 53 per cent for KP and CO, respectively. Safety of treatments was excellent in 97 per cent of patients treated with Kelfiprim and 87 per cent treated with co-trimoxazole. Two patients, one in each group, were dropped from the study because of adverse reactions.

Topics: Anti-Infective Agents, Urinary; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Random Allocation; Recurrence; Sulfalene; Sulfamethoxazole; Sulfanilamides; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections

A double-blind, multi-centre trial was carried out in 72 patients with acute or chronic infections of the lower respiratory tract to compare the efficacy and tolerance of a sulfamethopyrazine (200 mg)/trimethoprim (250 mg) combination with that of the established combination co-trimoxazole (400 mg sulphamethoxazole plus 80 mg trimethoprim). Patients received treatment for 10 days either with 2 capsules of co-trimoxazole twice daily or in the newer combination group with 2 capsules on Day 1 but then only 1 capsule daily for the remainder of the treatment period. The results of clinical, bacteriological and functional tests showed an excellent or good response in over 90% of patients in each group. There was no statistically significant difference in effectiveness of treatment with the once-daily sulfamethopyrazine/trimethoprim regime compared with co-trimoxazole given twice daily, and both treatments were well tolerated, with only a few mild side-effects, mainly gastro-intestinal ones, being reported.

Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Drug Combinations; Female; Humans; Lung; Male; Middle Aged; Respiratory Tract Infections; Sputum; Sulfalene; Sulfamethoxazole; Sulfanilamides; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Two fixed trimethoprim-sulfonamide combinations were compared in a clinical trial for their effectiveness and safety in the treatment of patients with acute lower respiratory tract infections (pneumonia, bronchopenumonia, purulent tracheobronchitis, ect.). 46 in-patients were randomly allocated to Kelfiprim (trimethoprim 250 mg + sulfalene (sulfamethopyrazine) 200 mg) or to co-trimoxazole (trimethoprim 320 mg + sulfamethoxazole 1600 mg) and were treated for 1-2 weeks under double-blind conditions. Assessment of effectiveness was based on daily follow-up of subjective and objective signs and symptoms, on changes in X-ray picture, and on microbiological and laboratory findings. Response to therapy was excellent or good in 86% of patients receiving Kelfiprim and in 79% of those given cotrimoxazole. Transient side-effects were observed in three patients under Kelfiprim (two allergic reactions and one G.I. complaint) and in one under co-trimoxazole (altered kidney function).

Topics: Adult; Aged; Blood Cell Count; Blood Urea Nitrogen; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Respiratory Tract Infections; Sulfalene; Sulfamethoxazole; Sulfanilamides; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

A new combination of trimethoprim with a sulphonamide, named Kelfiprim, differs from cotrimoxazole in that: a) the sulpha drug is sulphamethopyrazine instead of sulphamethoxazole; b) the trimethoprim to sulpha ratio is 5:4 instead of 1:5; c) the presence of a long-acting sulphonamide allows the administration of a daily dose of one capsule, following an initial loading dose of two capsules; d) a reduced amount of trimethoprim is given, as compared to cotrimoxazole, without any decrease of efficacy. Kelfiprim [KP] was compared to cotrimoxazole [Co] in a multicentre double blind trial. Sixty four patients suffering from acute and chronic infections of the upper and lower urinary tract entered the study. Urine sterilisation and clinical improvement without relapses showed no differences from the two treatment groups. Tolerance was excellent except in two patients, one treated with KP and the other treated with Co, who showed a transient exanthema.

Topics: Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Sulfalene; Sulfamethoxazole; Sulfanilamides; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections