Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults

NCT01092351 | Completed Phase 4

• 1 other identifier: NIT 001-2006
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given twice daily for seven days in the treatment of adult patients with microbiologically confirmed uncomplicated urinary tract infection. Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.

Conditions

Urinary Tract Infection

Keywords

urinary tract infection; nitrofurantoin

Outcome Measures

Primary Outcomes (1)

• Evaluation of bacteriological efficacy

  Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.

  after 12-42 days

Secondary Outcomes (2)

• Evaluation of clinical efficacy

  after 12-42 days

• Evaluation of safety and tolerability

  1-42 days

Study Arms (1)

Nitrofurantoin

EXPERIMENTAL

Adult patients with a microbiologically confirmed uncomplicated urinary tract infection

Drug: Nitrofurantoin

Interventions

Nitrofurantoin DRUG

100 mg retard capsules to be taken twice daily for seven days

Also known as: Uvamin retard

Nitrofurantoin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-pregnant women and men aged above 18 years old
• presence of ≥ 2 signs or symptoms suggestive of a UTI (dysuria, urinary frequency, urgency, suprapubic pain) with onset 10 days before enrollment
• asymptomatic patients with available positive urine culture
• pyuria defined as positive leucocyte esterase (LE) test with any color change after two minutes
• collection of clean-voided midstream urine sample for culture and susceptibility testing to confirm bacteriuria
• normal renal function (defined as blood creatinine \< 1.4 mg/100 ml)
• able to take oral medication on an outpatient basis
• written informed consent before enrollment

You may not qualify if:

• suspicion of complicated UTI (presence of fever above 38°C, flank pain, known urologic structural abnormality) or prostatitis
• negative urine dipslide results (uropathogen \< 100000 CFU (colony-forming units)/mL) or presence of nitrofurantoin resistant isolate uropathogens or mixed cultures of more than two isolates
• symptoms of UTI within the past 4 weeks
• evidence of predisposing factor to UTI (e.g. calculi, stricture, primary renal disease like polycystic renal diseases and neurogenic bladder)
• medical history of anaemia, complicated diabetes mellitus, peripheral neuropathy, vitamin B deficiency, renal insufficiency, other significant renal, hepatic or lung diseases
• medical history of glucose-6-phosphate dehydrogenase deficiency (G6PD)
• electrolytes disorders
• pregnant, breast-feeding women or not using medically accepted, effective method of birth control
• history of nitrofurantoin hypersensitivity
• use of systemic bacteriological agent within 48 hours before enrollment

Sponsors & Collaborators

• Mepha Ltd.: lead

Study Sites (1)

Cif Biotec, Medica Sur

Mexico City, 14050, Mexico

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Nitrofurantoin

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

Study Officials

• Arturo Mendoza Valdes, MD

  Cif Biotec, Medical Sur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 24, 2010
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 24, 2010

Record last verified: 2010-03

Locations

ME (1)