COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN

NCT06518291 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB-741
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fosfomycin and nitrofurantoin are increasingly being prescribed in outpatients for the oral treatment of urinary tract infection (UTI). The newest guidelines for empirical treatment of women with uncomplicated urinary tract infections (UTIs) advise clinicians to choose among three venerable antibiotics: trimethoprim-sulfamethoxazole, nitrofurantoin, and fosfomycin. Although both nitrofurantoin and fosfomycin have shown efficacy against most urinary pathogens, no recent head-to-head comparisons have been reported. So, this study will be conducted to compare effectiveness of both drugs.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• clinical response following completion of therapy by history

  7 days

Secondary Outcomes (1)

• bacteriologic response after therapy completion by urine culture test result

  14 days

Study Arms (2)

nitrofurantoin group

ACTIVE COMPARATOR

Drug: Nitrofurantoin 100 MG

Fosfomycin group

ACTIVE COMPARATOR

Drug: Fosfomycin

Interventions

Nitrofurantoin 100 MG DRUG

Comparing two drugs in UTI treatment

nitrofurantoin group

Fosfomycin DRUG

treatment of UTI

Fosfomycin group

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) Pregnancy and lactation 2) Suspected upper UTI (presence of fever, chills, or flank pain) 3) Antibiotic use or any symptoms consistent with UTI in the preceding 4 weeks 4) Indwelling urinary catheter or otherwise complicated UTI 5) Immunosuppression (untreated infection with HIV, ongoing chemotherapy or radiation therapy, use of high-dose corticosteroids or other immunosuppressive medication) 6) Renal insufficiency (creatinine clearance \<30 mL/min).

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Nitrofurantoin; Fosfomycin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 24, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share