Efficacy and Safety of Fosfomycin Single-Dose Therapy Compared to Nitrofurantoin and Cephalosporin in Pregnant Women with Lower Urinary Tract Infection: A Randomized Controlled Trial

Abstract

Background: Fosfomycin is a bactericidal drug that inhibits bacterial cell wall and also reduces the adherence ability of bacteria to uro-epithelial cells with a broad anti-bacterial activity against both Gram-negative and Gram-positive. Objective: To compare the efficacy and safety of fosfomycin compared to nitrofurantoin and cephalosporin in pregnant women presented with lower urinary tract infection. Patients and Methods: This was a double blinded, randomized controlled trial conducted at Shebin El-Kom Teaching Hospital from Aug 2019 to Aug 2020. Patients experienced uncomplicated lower urinary tract infection either asymptomatic bacteriuria or cystitis were recruited. Patients were randomly allocated via a random table number into three groups, each group comprised 35 patients. Group I received 3 g oral fosfomycin weekly, group II received 100 mg oral nitrofurantoin three times daily, and group III received 500 mg oral cephalosporin three times daily. After 7 days of treatment, all studied groups were subjected to urine sampling and culture analysis and were examined for occurrence of side effects. Results: All patients enrolled in our study had uncomplicated lower urinary tract infection either cystitis (n=85 cases) or asymptomatic bacteriuria (n=20 cases). There was clinical difference in urine pus cells and urine culture in fosfomycin after treatment compared to other groups. The side effects were reported in 7 cases with fosfomycin compared to 14 in other two groups with significant difference. \nConclusion: Fosfomycin tromethamine was proved to be more effective, safe, and fewer side effects were reported, which makes fosfomycin the drug of choice for uncomplicated lower urinary tract infection during pregnancy.