CLINICAL TRIALS PROFILE FOR FOSFOMYCIN DISODIUM
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All Clinical Trials for FOSFOMYCIN DISODIUM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02178254 ↗ | Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2014-08-01 | The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug, Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to dosing on Day 1 of Period 1 prior to study screening. |
| NCT03235947 ↗ | Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients | Completed | Laboratorios Senosiain, S.A. de C.V. | Phase 4 | 2016-09-07 | A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate. |
| NCT03235947 ↗ | Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients | Completed | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Phase 4 | 2016-09-07 | A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate. |
| NCT03709914 ↗ | PK Study of Single-Dose ZTI-01 in Children ( | Recruiting | Nabriva Therapeutics AG | Phase 1 | 2018-05-24 | Phase 1 study, a single dose of ZTI-01 given to pediatric subjects (under 12 years of age) who require antibiotic therapy to see what the body does to the drug (pharmacokinetics) and to compare if these effects are similar to those observed in adults at a 6g ZTI-01 dose. Study will help establish pediatric dosing in younger children by age cohort. This is a multiple-center, open-label, PK study of ZTI-01 (fosfomycin for injection) single dose scaled by allometric weight-modeling from an adult ZTI-01 dose of 6 grams. Eligible subjects must be receiving standard of care antibiotics for proven or suspected bacterial infection or for peri-operative prophylaxis surgery (in or out of hospital). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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