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Comparison of Fosfomycin versus Ciprofloxacin in the initial management of uncomplicated UTI

Fosfomycin tromethamine versus ciprofloxacin in the initial treatment of symptomatic UTI- a prospective randomized clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009922
Enrollment
120
Registered
2017-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Urinary Tract Infection Health Condition 2: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Fosfomycin Tromethamine: One Sachet containing 3gms of fosfomycin trometamine in powder form to be taken as a single dose in a glass of water. Control Intervention1: Ciprofloxacin: Tab

Sponsors

University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients aged above 18 years giving informed consent to participate in the study 2. Patients with clinical symptoms of uncomplicated UTI 3. Patients with pyuria documented on dipstick leucocyte esterase or by urine microscopy with pus cells.

Exclusion criteria

Exclusion criteria: 1. Patients not willing for consent for inclusion in the above study. 2. Asymptomatic bacteriuria 3. Complicated UTI 4. Patients on any antibiotic therapy in the last 48 hours 5. Patients with known drug allergy to Ciprofloxacin or Fosfomycin 6. Patients with known contraindications to Ciprofloxacin or Fosfomycin 7. Patients on Metoclopromide, pregnancy, children

Design outcomes

Primary

MeasureTime frame
1. Subjective Clinical relief of symptoms. 2. Absence of pyuria by negative urine dipstick leucocyte esterase test . Timepoint: 3rd day

Secondary

MeasureTime frame
1. Bacterial spectrum, antimicrobial sensitivity pattern, of symptomatic UTI (with special reference to Fosfomycin). 2. Incidence of UTI caused by extended spectrum β-lactamase producing (ESBL) strains of Escherichia coli. 3. To evaluate the possible risk factors in the causation of UTI in our patient setting. 4. Side effects, ADRs and ADEs following administration of the drugs. Timepoint: 3rd day

Countries

India

Contacts

Public ContactDr Sheikh Mohd Murtaza

University College of Medical Sciences University of Delhi GTB Hospital

murtazasm2009@gmail.com22586262

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026