CystitisPhase 4NCT00361998
Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis
A Phase 4 study testing NITROFURANTOIN MACROCRYSTALS in people with Cystitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystitis
- What is being tested?
- NITROFURANTOIN MACROCRYSTALS
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Jan 2007
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal healthy women
- Uncomplicated cystitis
Who cannot join
- Postmenopausal women
- Complicated UTI
- Women with catheter
- Women with recurrent UTI
- Pregnancy
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Israel1 site
Research Unit, Clalit Health Services, Haifa and Western Galillee District
Haifa, 35024
About this study
Official title: Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis
Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
Read the detailed description
The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.
- Conditions
- Cystitis
- Being tested
- NITROFURANTOIN MACROCRYSTALS
- Keywords
- Uncomplicated Cystitis, Nitrofurantoin Macrocrystals
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NITROFURANTOIN MACROCRYSTALSDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological efficacy
Secondary outcomes (1)
Clinical efficacy and side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startSep 2006
- Study completionJan 2007
Why it stopped: recruitment failed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Investigators
- Raul Raz, M.D., Principal investigator, Infectious Diseases Unit, HaEmek Medical Center, Afula, IsraelUzi Milman, M.D., Principal investigator, Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361998
- Sponsor's protocol ID
- 0706
- Status last verified
- Mar 2007
- First submitted
- 8 Aug 2006
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis
- ClinicalTrials.gov ID
- NCT00361998
- Acronym / sponsor ID
- 0706
- Conditions
- Cystitis
- Keywords
- Uncomplicated Cystitis, Nitrofurantoin Macrocrystals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment failed
- Enrolment
- 400 participants
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Sep 2006
- Study completion
- Jan 2007
- First posted
- 9 Aug 2006 (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.
Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
Detailed description
The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal healthy women
- Uncomplicated cystitis
Key exclusion criteria (6 listed)
- Postmenopausal women
- Complicated UTI
- Women with catheter
- Women with recurrent UTI
- Pregnancy
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 MACROCRYSTALS | Drug | – |
Primary outcome
Microbiological efficacy
1 secondary outcome
Clinical efficacy and side effects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
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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.
Raul Raz, M.D. principal investigator
Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
Uzi Milman, M.D. principal investigator
Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.
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 MACROCRYSTALS in people with Cystitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 2 Mar 2007. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Microbiological efficacy. 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 2 Mar 2007.