Single-Dose ZTI-01 for Pediatric Patients

(Pediatric_PK Trial)

This trial tests a single dose of ZTI-01, an antibiotic, in children under 12 who need treatment for bacterial infections. The goal is to understand how their bodies process the drug compared to adults, which can help determine the right dose for children. Children already receiving antibiotics for a known or suspected infection or for surgery preparation might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

The trial does not specify if you need to stop taking your current medications. However, you must be receiving standard antibiotics for a bacterial infection to participate.

Research has shown that fosfomycin, the main ingredient in ZTI-01, is very safe for children and is well-tolerated even with long-term use. Studies have found that fosfomycin can be safely combined with many other intravenous drugs, allowing it to be administered alongside other treatments. Although data on high doses is limited, existing evidence supports its safety in children. Overall, current studies and its use in other conditions consider fosfomycin safe.¹²³⁴⁵

Researchers are excited about ZTI-01 because it offers a fresh approach to treating bacterial infections in children using the active ingredient fosfomycin. Unlike many standard antibiotics, fosfomycin works by uniquely targeting bacterial cell wall synthesis, which can be effective against resistant strains. Additionally, ZTI-01 is administered as a single intravenous dose, potentially simplifying treatment and improving compliance compared to multi-dose regimens. This combination of a novel action mechanism and simplified delivery makes ZTI-01 a promising candidate in the fight against pediatric bacterial infections.

Research has shown that ZTI-01, also known as fosfomycin for injection, effectively treats serious infections in children, particularly those caused by bacteria resistant to other treatments. It has successfully treated complicated urinary tract infections and pneumonia in both adults and children. Studies have found that fosfomycin works well against tough bacteria often resistant to other antibiotics. Although fosfomycin is mainly used for urinary tract infections, researchers are exploring its use for other serious infections due to its effectiveness. Early findings suggest that fosfomycin could be a valuable option for treating severe infections in children, offering a new way to combat resistant germs. Participants in this trial will receive a single dose of ZTI-01, with different cohorts based on age to evaluate its safety and effectiveness in pediatric patients.¹⁶⁷⁸⁹