Uncomplicated Bacterial CystitisPhase 4NCT01749605

A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department

A Phase 4 study testing Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days and ciprofloxacin 250 mg BID x 3 days in people with Uncomplicated Bacterial Cystitis, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Uncomplicated Bacterial Cystitis
What is being tested?: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days and ciprofloxacin 250 mg BID x 3 days
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Jan 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

pre-menopausal females
ages 18-45 years old
symptoms of a UTI (dysuria, frequency, urgency)

Who cannot join

Onset of symptoms >7 days prior to the ED visit
Non-English speaking
Symptoms of pyelonephritis
Diabetic
Indications of sepsis
Immunocompromised

Show all 16Show fewer

Currently using prophylactic antimicrobials
Medications that could interfere with study drug
Pregnant
Lactating
History of kidney or liver disease
Vaginal symptoms
Presence of a urinary catheter
Treatment for UBC <2 weeks prior to ED visit
Known allergy to study drug
Unavailable for follow-up

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.

Conditions: Uncomplicated Bacterial Cystitis
Being tested: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days, ciprofloxacin 250 mg BID x 3 days

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 daysDrug
ciprofloxacin 250 mg BID x 3 daysDrug

Study groups in NCT01749605
Study group	Role	What they receive
nitrofurantoin 100 mg	Active comparator	Not described Receives: Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
Ciprofloxacin 250 mg	Active comparator	Not described Receives: Drug: ciprofloxacin 250 mg BID x 3 days

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Cure at Day 7
Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jan 2012

First posted13 Dec 2012 (estimated)
Study startOct 2010
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Uncomplicated Bacterial CystitisStudies of the same condition, open and under way.
More trials run by University of IowaThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01749605
Sponsor's protocol ID: 201005757
Status last verified: May 2017
First submitted: 11 Dec 2012
Last updated: 31 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
ClinicalTrials.gov ID: NCT01749605
Acronym / sponsor ID: 201005757
Conditions: Uncomplicated Bacterial Cystitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: Oct 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 13 Dec 2012 (estimated)
Results: Posted 27 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
nitrofurantoin 100 mg	Active comparator	Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
Ciprofloxacin 250 mg	Active comparator	Drug: ciprofloxacin 250 mg BID x 3 days

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

pre-menopausal females
ages 18-45 years old
symptoms of a UTI (dysuria, frequency, urgency)

Key exclusion criteria (16 listed)

Onset of symptoms >7 days prior to the ED visit
Non-English speaking
Symptoms of pyelonephritis
Diabetic
Indications of sepsis

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
Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days	Drug	nitrofurantoin 100 mg
ciprofloxacin 250 mg BID x 3 days	Drug	Ciprofloxacin 250 mg

Primary outcome

Number of Participants With Clinical Cure at Day 7
Time frame: 7 days
Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)

Results and safety

Results posted to the registry on 27 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nitrofurantoin 100 mg	18	14
Ciprofloxacin 250 mg	17	14

Primary outcome: Number of Participants With Clinical Cure at Day 7

Time frame: 7 days. Number. Unit: participants

Measure	Nitrofurantoin 100 mg n = 14	Ciprofloxacin 250 mg n = 14
Value	13	12

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nitrofurantoin 100 mg	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Ciprofloxacin 250 mg	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 16 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 31 May 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Clinical Cure at Day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01749605.

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 31 May 2017.