Clinical Trials Logo
  1. Home
  2. Cystitis
  3. NCT00361998
  4. Details
NCT00361998 Clinical Trial

Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis

Cystitis Clinical Trial

Official title:
Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00361998
Other study ID # 0706
Secondary ID
Status Withdrawn
Phase Phase 4
First received August 8, 2006
Last updated March 1, 2007
Start date September 2006
Est. completion date January 2007

Study information
Verified date March 2007
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 400
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. Premenopausal healthy women

2. Uncomplicated cystitis

Exclusion Criteria:

1. Postmenopausal women

2. Complicated UTI

3. Women with catheter

4. Women with recurrent UTI

5. Pregnancy

6. Diabetes Mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NITROFURANTOIN MACROCRYSTALS

Locations
Country Name City State
Israel Research Unit, Clalit Health Services, Haifa and Western Galillee District Haifa

Sponsors (2)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microbiological efficacy
Secondary Clinical efficacy and side effects
See also
  Status Clinical Trial Phase
Completed NCT03275623 - Management of Sub-Clinical Bacteriuria in Pregnancy Phase 4
Not yet recruiting NCT05055544 - Bearberry in the Treatment of Cystitis N/A
Active, not recruiting NCT01966653 - Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women Phase 4
Withdrawn NCT01527019 - Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI) Phase 3
Completed NCT03877289 - Efficacy of Oxybutynin in Paediatric Cystitis Phase 4
Completed NCT05584657 - Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women Phase 3
Terminated NCT00164099 - The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study Phase 4
Completed NCT00528476 - Risk Factors for Recurrent Urinary Tract Infection in Children N/A
Completed NCT04987164 - Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics
Completed NCT01861353 - Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children N/A
Completed NCT00957333 - Effects of Ketamine on Human Bladders and Its Possible Mechanisms N/A
Completed NCT05945667 - Efficacy and Safety of Uronext® in Women With Cystitis N/A
Recruiting NCT05360914 - Hospital at Home for Elderly Acute Ill Patients N/A
Completed NCT04272281 - Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care N/A
Completed NCT03425396 - Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis Phase 2
Completed NCT05260554 - Effect of Cranberry Extract on the Urinary System
Unknown status NCT00622076 - Postoperative Catheterization After Anterior Colporrhaphy N/A
Completed NCT00801021 - Treatment and/or Prevention of Urinary Tract Infections Phase 1
Terminated NCT01060254 - A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain Phase 2
Not yet recruiting NCT06391164 - Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis Phase 2