Uncomplicated Urinary Tract InfectionPhase 2NCT03425396
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
A Phase 2 study testing Omadacycline tablets and Nitrofurantoin capsules in people with Uncomplicated Urinary Tract Infection and Cystitis, run by Paratek Pharmaceuticals Inc at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uncomplicated Urinary Tract Infection, Cystitis
- What is being tested?
- Omadacycline tablets and Nitrofurantoin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 23 sitesUnited States
- Study dates
- 4 Jan 2018to 5 Jun 2019
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants, age 18 or older who have signed the informed consent form
- Must have a qualifying uncomplicated urinary tract infection
- Participants 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
Who cannot join
- Males
- Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
- Evidence of significant immunological disease
- Has received an investigational drug within the past 30 days
- Participants who are pregnant or nursing
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Site 114
Aventura, Florida, 33180
Site 122
Berlin, New Jersey, 08009
Site 106
Chula Vista, California, 91911
Site 102
DeLand, Florida, 32720
Site 103
Hialeah, Florida, 33015
Site 131
Houston, Texas, 77061
Site 104
Jackson, Tennessee, 38305
Site 125
Jacksonville, Florida, 32256
Site 101
La Mesa, California, 91942
Site 132
Las Vegas, Nevada, 89106
Site 108
Las Vegas, Nevada, 89109
Site 109
Los Angeles, California, 90017
Site 121
Miami, Florida, 33126
Site 130
Miami, Florida, 33126
Site 115
Miami, Florida, 33134
Site 127
Miami Springs, Florida, 33166
Site 113
Newton, Kansas, 67114
Site 112
Omaha, Nebraska, 68144
Site 126
Orlando, Florida, 82306
Site 118
Raleigh, North Carolina, 27612
Site 120
San Antonio, Texas, 78229
Site 105
Smyrna, Tennessee, 37167
Site 110
Wichita, Kansas, 67207
About this study
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
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.
Read the detailed description
Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.
- Conditions
- Uncomplicated Urinary Tract Infection, Cystitis
- Being tested
- Omadacycline tablets, Nitrofurantoin capsules
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omadacycline tabletsDrug
Oral Omadacycline
Nitrofurantoin capsulesDrug
Oral Nitrofurantoin
| Study group | Role | What they receive |
|---|---|---|
| Omadacycline 300/300 once every 24 hours | Experimental | Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. Receives: Drug: Omadacycline tablets |
| Omadacycline 450/300 once every 24 hours | Experimental | Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. Receives: Drug: Omadacycline tablets |
| Omadacycline 450/450 once every 24 hours | Experimental | Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. Receives: Drug: Omadacycline tablets |
| Omadacycline 450/450 once every 12 hours | Experimental | Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. Receives: Drug: Omadacycline tablets |
| Nitrofurantoin 100/100 once every 12 hours | Active comparator | Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. Receives: Drug: Nitrofurantoin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Measured: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Secondary outcomes (12)
Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
Measured: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
Measured: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Measured: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Measured: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure or indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Measured: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed
Measured: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Measured: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed.
Measured: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population)
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at <10^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
Measured: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population)
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at <10^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
Measured: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at <10^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
Measured: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population)
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at <10^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
Measured: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start4 Jan 2018
- Primary completion15 May 2019
- Study completion5 Jun 2019
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425396
- Sponsor's protocol ID
- PTK0796-UUTI-17201
- Status last verified
- Jun 2020
- First submitted
- 28 Dec 2017
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03425396
- Acronym / sponsor ID
- PTK0796-UUTI-17201
- Conditions
- Uncomplicated Urinary Tract Infection, Cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Omadacycline 300/300 once every 24 hours | Experimental | Drug: Omadacycline tabletsParticipants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. |
| Omadacycline 450/300 once every 24 hours | Experimental | Drug: Omadacycline tabletsParticipants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. |
| Omadacycline 450/450 once every 24 hours | Experimental | Drug: Omadacycline tabletsParticipants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. |
| Omadacycline 450/450 once every 12 hours | Experimental | Drug: Omadacycline tabletsParticipants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. |
| Nitrofurantoin 100/100 once every 12 hours | Active comparator | Drug: Nitrofurantoin capsulesParticipants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants, age 18 or older who have signed the informed consent form
- Must have a qualifying uncomplicated urinary tract infection
- Participants 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
Key exclusion criteria (5 listed)
- Males
- Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
- Evidence of significant immunological disease
- Has received an investigational drug within the past 30 days
- Participants who are pregnant or nursing
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 |
|---|---|---|
| Omadacycline tabletsOral Omadacycline | Drug | Omadacycline 300/300 once every 24 hours, Omadacycline 450/300 once every 24 hours, Omadacycline 450/450 once every 12 hours, Omadacycline 450/450 once every 24 hours |
| Nitrofurantoin capsulesOral Nitrofurantoin | Drug | Nitrofurantoin 100/100 once every 12 hours |
Primary outcome
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
12 secondary outcomes
Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population)
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population)
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population)
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population)
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population)
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population)
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omadacycline tablets and Nitrofurantoin capsules in people with Uncomplicated Urinary Tract Infection and Cystitis, run by Paratek Pharmaceuticals Inc at 23 sites in United States.
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 4 inclusion and 5 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Jun 2020). 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 an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) (time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)). 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 9 Jun 2020.