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

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092351
• Other study ID #: NIT 001-2006
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: March 22, 2010
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Mepha Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Nitrofurantoin
100 mg retard capsules to be taken twice daily for seven days

Locations

Country	Name	City	State
Mexico	Cif Biotec, Medica Sur	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Mepha Ltd.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of clinical efficacy	Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).	after 12-42 days	No
Secondary	Evaluation of safety and tolerability	Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events	1-42 days	No