Urinary Tract InfectionPhase 4NCT01092351
Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
A Phase 4 study testing Nitrofurantoin in people with Urinary Tract Infection, run by Mepha Ltd. at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Nitrofurantoin
- Keywords
- urinary tract infection, nitrofurantoin
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Uvamin retard
100 mg retard capsules to be taken twice daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantoin | Experimental | Adult patients with a microbiologically confirmed uncomplicated urinary tract infection Receives: Drug: Nitrofurantoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bacteriological efficacy
Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.
Measured: after 12-42 days
Secondary outcomes (2)
Evaluation of clinical efficacy
Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).
Measured: after 12-42 days
Evaluation of safety and tolerability
Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events
Measured: 1-42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mepha Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arturo Mendoza Valdes, MD, Principal investigator, Cif Biotec, Medical Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092351
- Sponsor's protocol ID
- NIT 001-2006
- Status last verified
- Mar 2010
- First submitted
- 15 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01092351
- Acronym / sponsor ID
- NIT 001-2006
- Conditions
- Urinary Tract Infection
- Keywords
- urinary tract infection, nitrofurantoin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mepha Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantoin | Experimental | Drug: NitrofurantoinAdult patients with a microbiologically confirmed uncomplicated urinary tract infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitrofurantoinAlso: Uvamin retard100 mg retard capsules to be taken twice daily for seven days | Drug | Nitrofurantoin |
Primary outcome
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.
2 secondary outcomes
Evaluation of clinical efficacy
Time frame: after 12-42 days
Evaluation of safety and tolerability
Time frame: 1-42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Mendoza Valdes, MD principal investigator
Cif Biotec, Medical Sur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin in people with Urinary Tract Infection, run by Mepha Ltd. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of bacteriological efficacy (time frame: after 12-42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.