A clinical study comparing two antibiotic treatments (nitrofurantoin and fosfomycin) for uncomplicated urinary tract infection in women

A Randomised controlled trial on Efficacy of Single dose Oral Fosfomycin versus 5 day Nitrofurantoin Therapy in Management of Uncomplicated Lower Urinary Tract Infections in Women - FOS-NITRO Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109552

Enrollment

100

Registered

2026-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Oral Fosfomycin (Single Dose): Single oral dose of fosfomycin trometamol 3 g for treatment of uncomplicated lower urinary tract infection. Control Intervention1: Oral Nitrofurantoin (5-

Eligibility

Inclusion criteria

Inclusion criteria: 1)Consenting women aged more than 18yrs of age 2) Women with at least 1 symptom of acute lower UTI (dysuria, urgency, frequency or suprapubic tenderness 3) Women with a urine dipstick test result positive for either nitrates or leukocyte esterase

Exclusion criteria

Exclusion criteria: 1) All non consenting women 2) All women aged less than 18yrs 3) All women who are pregnant 4) All lactating mothers 5) All women with suspected upper UTI (fever, chills or flank pain) 6) All women on antibiotic use 7) All women with symptoms consistent with UTI in preceding 4 weeks 8) Women with indwelling urinary catheter or otherwise complicated UTI 9) Women with recurrent UTI 10) Immunosuppressed women ( untreated infection with HIV, ongoing chemotherapy, ongoing radiation therapy, use of high-dose corticosteroids or immunosuppressive medications) 11) Women with Diabetes Mellitus 12) Women with Renal insufficiency (Creatinine clearance less than 30ml/min 13) Women lost to follow up

Design outcomes

Primary

Measure	Time frame
Clinical Response (Clinical resolution/failure/indeterminate)Timepoint: 28(+/-7) days after completion of therapy	—

Secondary

Measure	Time frame
Bacteriological response (eradication/failure)Timepoint: 14 plus or minus 2 days after completion of therapy 28 plus or minus 7 days after completion of therapy;Clinical responseTimepoint: 14 plus or minus 2 days after completion of therapy;Duration of symptoms after treatment initiationTimepoint: During treatment until symptom resolution;Adverse events due to study antibioticTimepoint: Throughout study period upto 28 plus or minus 7 days after completion of therapy;Satisfaction with treatmentTimepoint: 28 plus or minus 7 days after completion of therapy	—

Measure

Time frame

Bacteriological response (eradication/failure)Timepoint: 14 plus or minus 2 days after completion of therapy 28 plus or minus 7 days after completion of therapy;Clinical responseTimepoint: 14 plus or minus 2 days after completion of therapy;Duration of symptoms after treatment initiationTimepoint: During treatment until symptom resolution;Adverse events due to study antibioticTimepoint: Throughout study period upto 28 plus or minus 7 days after completion of therapy;Satisfaction with treatmentTimepoint: 28 plus or minus 7 days after completion of therapy

—

Countries

India

Contacts

Public ContactDr Sindhuka Meka

Datta Meghe Institution of Higher Education and Research

meemakhatri619@yahoo.com9822239465

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026