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Trial record 94 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

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ClinicalTrials.gov Identifier: NCT03425396
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.

Condition or disease Intervention/treatment Phase
Uncomplicated Urinary Tract Infection Cystitis Drug: Omadacycline; po tablets Drug: Nitrofurantoin, po capsules Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of Oral Omadacycline and Oral Nitrofurantoin in the Treatment of Female Adults With Cystitis
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omadacycline; Omadacycline tablets Drug: Omadacycline; po tablets
Oral Omadacycline

Active Comparator: Nitrofurantoin; Nitrofurantoin capsules Drug: Nitrofurantoin, po capsules
Oral Nitrofurantoin




Primary Outcome Measures :
  1. Investigator's assessment of clinical response at Post Treatment Evaluation (PTE) based on microbiological response. [ Time Frame: 14 days ]

    Clinical success is defined as sufficient resolution of cystitis signs and symptoms such that no additional antibacterial therapy is required for the current infection. Clinical response will be determined by the judgement of the investigator at the subject's post-treatment evaluation and will be based on the following factors:

    Microbiological Response: The subjects will present a urine sample at each visit and pathogen load will be measured via urine culture and urine dipstick analysis. Investigators will examine the results of these tests across all visits and will measure clinical success as a significant reduction in pathogen load such that the subjects do not require additional antibacterial therapy at the end of their 14-day time frame. All of these factors will be aggregated into the clinician's assessment of the subject.


  2. Investigator's assessment of clinical response at Post Treatment Evaluation (PTE) based on subject's report of UTI signs and symptoms. [ Time Frame: 14 days ]
    Each subject will record her assessment of UTI signs and symptoms severity using the UTI Symptoms Assessment questionnaire (UTISA) during each visit. The UTISA is a 14-item instrument asking about the severity and bothersomeness of seven key uUTI symptoms, and applies a 4-point scale: No Symptoms, Mild, Moderate, Severe. The investigator will review each subject's responses and decide at the end of their treatment if there is sufficient resolution of UTI signs and symptoms.

  3. Investigator's assessment of clinical response at Post Treatment Evaluation (PTE) based on subject's report of health and adverse events. [ Time Frame: 14 days ]
    Investigators will interview the subjects at each visit to ask questions about their general health, how they feel, and to report on any adverse events they may be experiencing. Investigators will factor in adverse event reports to their decision on each subject's clinical outcome at the end of their 14-day time frame.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects, age 18 or older who have signed the informed consent form
  • Must have a qualifying uncomplicated urinary tract infection
  • Subjects must not be pregnant at the time of enrollment
  • Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

  • Males
  • Evidence of complicated UTI, upper UTI, vaginitis, or STI
  • Evidence of significant immunological disease
  • Has received an investigational drug within the past 30 days
  • Subjects who are pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425396


Contacts
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Contact: Alissa Sirbu 484-751-4926 alissa.sirbu@paratekpharma.com
Contact: Amy Manley 484-682-4976 amy.manley@paratekpharma.com

Locations
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United States, Arkansas
Site 129 Recruiting
Little Rock, Arkansas, United States, 72212
Contact: Simpson         
United States, California
Site 106 Recruiting
Chula Vista, California, United States, 91911
Contact: Waters         
Contact    (760) 631-3056      
Site 101 Recruiting
La Mesa, California, United States, 91942
Contact: Overcash         
Contact    (619) 567-1550      
Site 109 Recruiting
Los Angeles, California, United States, 90017
Contact: Kowalczyk         
Contact    (562) 693-4477      
Site 116 Recruiting
Palm Springs, California, United States, 92264
Contact: Stapleton         
United States, Florida
Site 114 Recruiting
Aventura, Florida, United States, 33180
Contact: Schatz         
Contact    (305) 501-2779      
Site 102 Recruiting
DeLand, Florida, United States, 32720
Contact: Oguchi         
Contact    (386) 279-6181      
Site 103 Recruiting
Hialeah, Florida, United States, 33015
Contact: Acosta         
Contact    (305) 424-7420      
Site 127 Recruiting
Miami Springs, Florida, United States, 33166
Contact: Terrelonge         
Contact    (305) 885-8983      
Site 121 Recruiting
Miami, Florida, United States, 33126
Contact: Duardo Guerra         
Contact    (305) 387-3300      
Site 130 Recruiting
Miami, Florida, United States, 33126
Contact: Lam         
Site 115 Recruiting
Miami, Florida, United States, 33134
Contact: Iglesias         
Contact    (305) 249-1183      
Site 126 Recruiting
Orlando, Florida, United States, 82306
Contact: Dever         
Contact    (407) 425-5100      
United States, Kansas
Site 113 Recruiting
Newton, Kansas, United States, 67144
Contact: Sletcha         
Contact    (316) 804-7304      
United States, Nebraska
Site 112 Recruiting
Omaha, Nebraska, United States, 68144
Contact: Dunn         
Contact    (402) 934-0044      
United States, Nevada
Site 108 Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Sholeff         
Contact    (702) 410-2970      
United States, New Jersey
Site 122 Recruiting
Berlin, New Jersey, United States, 08009
Contact: Hassman         
Contact    (856) 753-7335      
United States, Texas
Site 123 Recruiting
Dallas, Texas, United States, 75204
Contact: Rai         
Contact    (214) 871-7000      
Site 124 Recruiting
Dallas, Texas, United States, 75230
Contact: Anderson         
Contact    (972) 480-3400      
Site 131 Recruiting
Houston, Texas, United States, 77061
Contact: Mbogua         
Sponsors and Collaborators
Paratek Pharmaceuticals Inc

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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03425396     History of Changes
Other Study ID Numbers: PTK0796-UUTI-17201
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Cystitis
Infection
Urologic Diseases
Urinary Bladder Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents