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

This study has been completed.
Sponsor:
Information provided by:
Mepha Ltd.
ClinicalTrials.gov Identifier:
NCT01092351
First received: March 15, 2010
Last updated: March 22, 2010
Last verified: March 2010
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Adrian Frentzel, Mepha Ltd.
ClinicalTrials.gov Identifier: NCT01092351     History of Changes
Other Study ID Numbers: NIT 001-2006
Study First Received: March 15, 2010
Last Updated: March 22, 2010
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Mepha Ltd.:
urinary tract infection
nitrofurantoin

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on July 20, 2014