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Kelfiprim versus co-trimoxazole in recurrent and persistent urinary tract infections: multicenter double-blind trial
Abstract:
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.
Insights
Kelfiprim (trimethoprim and sulfametopyrazine) demonstrated high efficacy and safety in treating persistent and recurrent urinary tract infections (UTIs). This new bactericidal agent showed comparable or superior results to co-trimoxazole in a clinical trial.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Medicine
Background:
- Urinary tract infections (UTIs) represent a significant public health challenge, often requiring effective antimicrobial therapy.
- Persistent and recurrent UTIs necessitate the evaluation of novel therapeutic agents with improved efficacy and safety profiles.
- Kelfiprim (KP), a combination of trimethoprim (T) and sulfametopyrazine (S), is a novel bactericidal agent developed for antimicrobial treatment.
Purpose of the Study:
- To evaluate the clinical value and comparative efficacy of Kelfiprim (KP) against co-trimoxazole (CO) in patients with persistent and recurrent UTIs.
- To assess the safety and tolerability of Kelfiprim (KP) compared to co-trimoxazole (CO) in the treatment of UTIs.
Main Methods:
- A controlled, multicenter, double-blind trial (MDBT) was conducted involving 76 patients diagnosed with persistent or recurrent UTIs.
- Patients received either Kelfiprim (KP) or co-trimoxazole (CO) with a specified daily dosage and a loading dose on the first day.
- Clinical response was assessed by urine culture, with a sterile urine sample at the end of treatment indicating a positive response.
Main Results:
- Kelfiprim (KP) achieved a response rate of approximately 90% in recurrent UTIs, compared to 85% for co-trimoxazole (CO).
- In persistent UTIs, Kelfiprim (KP) showed a recovery rate of 66.8%, outperforming co-trimoxazole (CO) at 53%.
- Treatment safety was excellent, with 97% of patients on Kelfiprim (KP) and 87% on co-trimoxazole (CO) experiencing no adverse reactions, with only two patients discontinued due to adverse events.
Conclusions:
- Kelfiprim (KP) is a clinically valuable therapeutic option for managing persistent and recurrent urinary tract infections.
- The efficacy and safety profile of Kelfiprim (KP) suggest it is a promising alternative to co-trimoxazole for UTI treatment.
- Further research may explore Kelfiprim's role in broader antimicrobial resistance strategies.