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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092351
First Posted: March 24, 2010
Last Update Posted: March 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mepha Ltd.
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection Drug: Nitrofurantoin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study on the Bacteriological and Clinical Efficacy and Safety of a Nitrofurantoin Formulation Given Twice Daily (Bid) for Seven Days in Uncomplicated Urinary Tract Infection in Adults

Resource links provided by NLM:


Further study details as provided by Mepha Ltd.:

Primary Outcome Measures:
  • Evaluation of bacteriological efficacy [ Time Frame: after 12-42 days ]
    Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.


Secondary Outcome Measures:
  • Evaluation of clinical efficacy [ Time Frame: after 12-42 days ]
    Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).

  • Evaluation of safety and tolerability [ Time Frame: 1-42 days ]
    Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events


Enrollment: 37
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitrofurantoin
Adult patients with a microbiologically confirmed uncomplicated urinary tract infection
Drug: Nitrofurantoin
100 mg retard capsules to be taken twice daily for seven days
Other Name: Uvamin retard

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092351


Locations
Mexico
Cif Biotec, Medica Sur
Mexico City, Mexico, 14050
Sponsors and Collaborators
Mepha Ltd.
Investigators
Principal Investigator: Arturo Mendoza Valdes, MD Cif Biotec, Medical Sur
  More Information

Responsible Party: Dr. Adrian Frentzel, Mepha Ltd.
ClinicalTrials.gov Identifier: NCT01092351     History of Changes
Other Study ID Numbers: NIT 001-2006
First Submitted: March 15, 2010
First Posted: March 24, 2010
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Mepha Ltd.:
urinary tract infection
nitrofurantoin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents