COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-83
SponsorShalamar Institute of Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult women aged 18 years and older presenting with at least 1 symptom of lower UTI such as dysuria, urgency, frequency, or suprapubic tenderness and a urine dipstick test result positive for either nitrites or leukocyte esterase. Confirmed UTI will require the presence of at least 1 of the 4 urinary symptoms required for inclusion and a positive urine culture (≥103 cfu/mL). 21

Disqualifiers

1) 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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nitrofurantoin 100 MG

    Drug

    Comparing two drugs in UTI treatment

  • Fosfomycin

    Drug

    treatment of UTI

Treatment groups

392 Participants
are divided into 2 treatment groups
Group A: nitrofurantoin groupActive comparator 1 intervention
Group B: Fosfomycin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

clinical response following completion of therapy by history

Time frame
7 days

Secondary outcomes

1

bacteriologic response after therapy completion by urine culture test result

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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