Acute PyelonephritisPhase 2NCT03757234

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

A Phase 2 study testing Omadacycline and Levofloxacin in people with Acute Pyelonephritis, run by Paratek Pharmaceuticals Inc at 31 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Acute Pyelonephritis
What is being tested?: Omadacycline and Levofloxacin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 31 sitesin 4 countries
Study dates: 19 Nov 2018to 24 Jul 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 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
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
Must be able to comply with all of the requirements of the study

Who cannot join

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
Evidence of significant immunological disease
Evidence of liver impairment or disease

Show all 13Show fewer

Evidence of unstable cardiac disease
Severe renal disease or requirement for dialysis
Evidence of septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
Has received an investigational drug within the past 30 days
Participants who are pregnant or nursing
Unable or unwilling to comply with the protocol requirements

Trial locations and contacts

31 sites in 4 countries.

Country

City, postcode or hospital

31 sites in 4 countries

Russia15 sites

Site 409
Krasnoyarsk, 660062
Site 408
Moscow, 141435
Site 410
Moscow, Moscow
Site 415
Penza, 440026
Site 407
Rostov-on-Don, 344022
Site 405
Rostov-on-Don, 344037
Site 411
Saint Petersburg, 194291
Site 406
Saint Petersburg, 195067
Site 402
Saint Petersburg, 196247
Site 412
Saint Petersburg, 197022
Site 403
Saint Petersburg, 197374
Site 414
Saint Petersburg, 198205
Site 401
Saint Petersburg, 198412
Site 404
Saint Petersburg, 199106
Site 413
Smolensk, 214018

Other trials in Russia

Ukraine7 sites

Site 502
Chernivtsi, 58001
Site 506
Dnipro, 49005
Site 505
Kharkiv, 61037
Site 504
Kyiv, 2660
Site 503
Kyiv, 4053
Site 501
Lviv, 79059
Site 507
Zaporizhzhya, 69600

Other trials in Ukraine

Latvia5 sites

Site 301
Daugavpils
Site 304
Liepāja, LV-3414
Site 305
Rēzekne
Site 302
Riga
Site 303
Valmiera

Other trials in Latvia

Georgia4 sites

Site 201
Tbilisi
Site 202
Tbilisi
Site 203
Tbilisi
Site 204
Tbilisi

Other trials in Georgia

About this study

Official title: A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.

Read the detailed description

This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2 study. Based on review of the efficacy and microbiology data, the DMC modified the randomization algorithm, and no further participants were enrolled in the following treatment arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv, and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.

Conditions: Acute Pyelonephritis
Being tested: Omadacycline, Levofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmadacyclineDrug
Also called Nuzyra
po tablets
LevofloxacinDrug
Also called Levaquin
iv solution/po tablets
OmadacyclineDrug
Also called Nuzyra
iv solution

Study groups in NCT03757234
Study group	Role	What they receive
Omadacycline 200 iv/200 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. Receives: Drug: Omadacycline
Omadacycline 200 iv/100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. Receives: Drug: Omadacycline
Omadacycline 200 iv/300 po or 100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state. Receives: Drug: Omadacycline
Omadacycline 200 iv/450 po or 100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state. Receives: Drug: Omadacycline
Levofloxacin 750 iv/750 po or iv	Active comparator	On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state. Receives: Drug: Levofloxacin

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 the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is 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 or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Measured: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
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 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.
Measured: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.
Measured: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.
Measured: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).

Secondary outcomes (1)

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.
Measured: up to approximately 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201824 Jul 2019

First posted28 Nov 2018
Study start19 Nov 2018
Primary completion26 Jun 2019
Study completion24 Jul 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 Acute PyelonephritisStudies 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: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03757234
Sponsor's protocol ID: PTK0796-AP-17202
Status last verified: Jul 2020
First submitted: 27 Nov 2018
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
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All Acute Pyelonephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 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 iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.
ClinicalTrials.gov ID: NCT03757234
Acronym / sponsor ID: PTK0796-AP-17202
Conditions: Acute Pyelonephritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: 19 Nov 2018 (actual)
Primary completion: 26 Jun 2019 (actual)
Study completion: 24 Jul 2019 (actual)
First posted: 28 Nov 2018 (actual)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 200 iv/200 iv	Experimental	Drug: OmadacyclineOn Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
Omadacycline 200 iv/100 iv	Experimental	Drug: OmadacyclineOn Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
Omadacycline 200 iv/300 po or 100 iv	Experimental	Drug: OmadacyclineOn Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
Omadacycline 200 iv/450 po or 100 iv	Experimental	Drug: OmadacyclineOn Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
Levofloxacin 750 iv/750 po or iv	Active comparator	Drug: LevofloxacinOn Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
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
Must be able to comply with all of the requirements of the study

Key exclusion criteria (13 listed)

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
Evidence of significant immunological disease

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
OmadacyclineAlso: Nuzyrapo tablets	Drug	Omadacycline 200 iv/300 po or 100 iv, Omadacycline 200 iv/450 po or 100 iv
LevofloxacinAlso: Levaquiniv solution/po tablets	Drug	Levofloxacin 750 iv/750 po or iv
OmadacyclineAlso: Nuzyraiv solution	Drug	Omadacycline 200 iv/100 iv, Omadacycline 200 iv/200 iv, Omadacycline 200 iv/300 po or 100 iv, Omadacycline 200 iv/450 po or 100 iv

Primary outcome

Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Time frame: Day 21 (A PTE occurred on Day 21 ± 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 the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is 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 or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.
Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.
Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.

1 secondary outcome

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: up to approximately 28 days

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omadacycline 200 iv/200 iv	75	72
Omadacycline 200 iv/100 iv	18	16
Omadacycline 200 iv/300 po or 100 iv	17	17
Omadacycline 200 iv/450 po or 100 iv	17	16
Levofloxacin 750 iv/750 po or iv	74	70

Primary outcome: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)

Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).. Count of participants. Unit: Participants

Measure	Omadacycline 200 iv/200 iv n = 75	Omadacycline 200 iv/100 iv n = 18	Omadacycline 200 iv/300 po or 100 iv n = 17	Omadacycline 200 iv/450 po or 100 iv n = 17	Levofloxacin 750 iv/750 po or iv n = 74
Clinical Success	68	15	15	16	69
Clinical Failure	5	1	2	0	1
Indeterminate	2	2	0	1	4

Omadacycline 200 iv/200 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -2.6 (95% CI -12.4 to 6.9)
Omadacycline 200 iv/100 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -9.9 (95% CI -34.8 to 5.3)
Omadacycline 200 iv/300 po or 100 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -5.0 (95% CI -30.6 to 8.2)

Population analysed: The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.

Primary outcome: Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)

Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).. Count of participants. Unit: Participants

Measure	Omadacycline 200 iv/200 iv n = 46	Omadacycline 200 iv/100 iv n = 11	Omadacycline 200 iv/300 po or 100 iv n = 14	Omadacycline 200 iv/450 po or 100 iv n = 13	Levofloxacin 750 iv/750 po or iv n = 52
Clinical Success	32	3	9	5	39
Clinical Failure	13	7	5	7	11
Indeterminate	1	1	0	1	2

Omadacycline 200 iv/200 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -5.4 (95% CI -23.6 to 12.7)
Omadacycline 200 iv/100 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -47.7 (95% CI -71.3 to -6.0)
Omadacycline 200 iv/300 po or 100 iv vs Levofloxacin 750 iv/750 po or iv: Treatment difference: -10.7 (95% CI -40.8 to 15.1)

Population analysed: The micro-ITT population consisted of participants in the ITT population who had an appropriately collected pretreatment baseline urine culture with at least 1 uropathogen at ≥10\^5 colony forming unit (CFU)/mL and not more than 2 bacterial isolates at any colony count.

Primary outcome: Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)

Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).. Count of participants. Unit: Participants

Measure	Omadacycline 200 iv/200 iv n = 64	Omadacycline 200 iv/100 iv n = 16	Omadacycline 200 iv/300 po or 100 iv n = 16	Omadacycline 200 iv/450 po or 100 iv n = 16	Levofloxacin 750 iv/750 po or iv n = 66
Value	51	15	14	13	54

Population analysed: The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.

Primary outcome: Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)

Time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).. Count of participants. Unit: Participants

Measure	Omadacycline 200 iv/200 iv n = 64	Omadacycline 200 iv/100 iv n = 16	Omadacycline 200 iv/300 po or 100 iv n = 16	Omadacycline 200 iv/450 po or 100 iv n = 16	Levofloxacin 750 iv/750 po or iv n = 66
Value	62	16	16	15	65

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to approximately 28 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omadacycline 200 iv/200 iv	0 of 75 (0%)	21 of 75 (28%)	0 of 75
Omadacycline 200 iv/100 iv	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Omadacycline 200 iv/300 po or 100 iv	2 of 17 (11.8%)	7 of 17 (41.2%)	0 of 17
Omadacycline 200 iv/450 po or 100 iv	2 of 17 (11.8%)	8 of 17 (47.1%)	0 of 17
Levofloxacin 750 iv/750 po or iv	2 of 74 (2.7%)	16 of 74 (21.6%)	0 of 74

Limitations and caveats (from the sponsor): In May 2019, the DMC modified the randomization algorithm based on their review of the data. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.

31 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omadacycline and Levofloxacin in people with Acute Pyelonephritis, run by Paratek Pharmaceuticals Inc at 31 sites in 4 countries.

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 5 inclusion and 13 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Russia, Ukraine, Latvia, Georgia. 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 7 Jul 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 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03757234.

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 7 Jul 2020.