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

Primary Purpose

Urinary Tract Infection

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Nitrofurantoin

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring urinary tract infection, nitrofurantoin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cif Biotec, Medica Sur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitrofurantoin

Arm Description

Adult patients with a microbiologically confirmed uncomplicated urinary tract infection

Outcomes

Primary Outcome Measures

Evaluation of bacteriological efficacy

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

Secondary Outcome Measures

Evaluation of clinical efficacy

Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).

Evaluation of safety and tolerability

Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events

Full Information

NCT ID

NCT01092351

First Posted

March 15, 2010

Last Updated

March 22, 2010

Sponsor

Mepha Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01092351

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mepha Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infection

Keywords

urinary tract infection, nitrofurantoin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nitrofurantoin

Arm Type

Experimental

Arm Description

Adult patients with a microbiologically confirmed uncomplicated urinary tract infection

Intervention Type

Drug

Intervention Name(s)

Nitrofurantoin

Other Intervention Name(s)

Uvamin retard

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation of bacteriological efficacy

Description

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

Time Frame

after 12-42 days

Secondary Outcome Measure Information:

Title

Evaluation of clinical efficacy

Description

Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).

Time Frame

after 12-42 days

Title

Evaluation of safety and tolerability

Description

Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events

Time Frame

1-42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arturo Mendoza Valdes, MD

Organizational Affiliation

Cif Biotec, Medical Sur

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cif Biotec, Medica Sur

City

Mexico City

ZIP/Postal Code

14050

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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