Trial · NCT03425396
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
NCT03425396, Phase 2, Completed, Paratek Pharmaceuticals Inc; results first posted 2020-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis. Trials, record NCT03425396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03425396
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
- NCT number
- NCT03425396
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 225 participants, actual
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Conditions
- Uncomplicated Urinary Tract Infection, Cystitis
- Interventions
- Omadacycline tablets, Nitrofurantoin capsules
- First posted
- 2018-02-07
- Last updated
- 2020-06-09
- Results first posted
- 2020-06-04
- Limitations and caveats
An additional treatment group (omadacycline 450/450 once every 12 hours) was added with Protocol Amendment 2. However, the majority of enrollment was completed by this time, and therefore, fewer participants were enrolled in this group.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population) | 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 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | 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 |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | 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. |
| Secondary | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | 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. |
| Secondary | Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The Intent-to-Treat (ITT) Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The ITT Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment Baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 colony forming unit (CFU)/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The clinically evaluable (CE)-EOT population consisted of all ITT participants who completed the EOT visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criterias. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The clinically evaluable (CE)-PTE population consisted of all ITT participants who completed the PTE visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criterias. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The micro-ITT population consisted of consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The ITT Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The clinically evaluable (CE)-FFU Population consisted of all ITT participants who completed the FFU visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 300/300 Once Every 24 Hours | Clinical Success | 48 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/300 Once Every 24 Hours | Clinical Success | 42 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/450 Once Every 24 Hours | Clinical Success | 46 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/450 Once Every 12 Hours | Clinical Success | 7 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Nitrofurantoin 100/100 Once Every 12 Hours | Clinical Success | 49 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 300/300 Once Every 24 Hours | Clinical Failure | 5 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/300 Once Every 24 Hours | Clinical Failure | 6 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/450 Once Every 24 Hours | Clinical Failure | 5 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Omadacycline 450/450 Once Every 12 Hours | Clinical Failure | 0 | Participants | |
| Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Nitrofurantoin 100/100 Once Every 12 Hours | Clinical Failure | 5 | Participants |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omadacycline 300/300 Once Every 24 Hours | 55 | |
| Overall Study | STARTED | Omadacycline 450/300 Once Every 24 Hours | 54 | |
| Overall Study | STARTED | Omadacycline 450/450 Once Every 24 Hours | 54 | |
| Overall Study | STARTED | Omadacycline 450/450 Once Every 12 Hours | 8 | |
| Overall Study | STARTED | Nitrofurantoin 100/100 Once Every 12 Hours | 54 | |
| Overall Study | Completed End of Treatment Visit | Omadacycline 300/300 Once Every 24 Hours | 53 | |
| Overall Study | Completed End of Treatment Visit | Omadacycline 450/300 Once Every 24 Hours | 52 | |
| Overall Study | Completed End of Treatment Visit | Omadacycline 450/450 Once Every 24 Hours | 51 | |
| Overall Study | Completed End of Treatment Visit | Omadacycline 450/450 Once Every 12 Hours | 7 | |
| Overall Study | Completed End of Treatment Visit | Nitrofurantoin 100/100 Once Every 12 Hours | 53 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Omadacycline 300/300 Once Every 24 Hours | 0 | 55 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Omadacycline 450/300 Once Every 24 Hours | 0 | 54 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Omadacycline 450/450 Once Every 24 Hours | 0 | 54 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Omadacycline 450/450 Once Every 12 Hours | 1 | 8 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Nitrofurantoin 100/100 Once Every 12 Hours | 0 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Omadacycline 300/300 Once Every 24 Hours | 2 | 55 | |
| other | Diarrhoea | Gastrointestinal disorders | Omadacycline 450/300 Once Every 24 Hours | 1 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Omadacycline 450/450 Once Every 24 Hours | 3 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Omadacycline 450/450 Once Every 12 Hours | 0 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Nitrofurantoin 100/100 Once Every 12 Hours | 2 | 54 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omadacycline 300/300 Once Every 24 Hours | 0 | 55 |
| Total, all-cause mortality | Omadacycline 450/300 Once Every 24 Hours | 0 | 54 |
| Total, all-cause mortality | Omadacycline 450/450 Once Every 24 Hours | 0 | 54 |
| Total, all-cause mortality | Omadacycline 450/450 Once Every 12 Hours | 0 | 8 |
| Total, all-cause mortality | Nitrofurantoin 100/100 Once Every 12 Hours | 0 | 54 |
| Total, other adverse events | Omadacycline 300/300 Once Every 24 Hours | 16 | 55 |
| Total, other adverse events | Omadacycline 450/300 Once Every 24 Hours | 13 | 54 |
| Total, other adverse events | Omadacycline 450/450 Once Every 24 Hours | 15 | 54 |
| Total, other adverse events | Omadacycline 450/450 Once Every 12 Hours | 4 | 8 |
| Total, other adverse events | Nitrofurantoin 100/100 Once Every 12 Hours | 9 | 54 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03425396/results?page=2