A Phase 3 interventional study of PTK 0796 and linezolid in Skin Diseases, Infectious, sponsored by Paratek Pharmaceuticals Inc. Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by Paratek Pharmaceuticals Inc · Phase 3, Interventional, and Treatment
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0804 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
45 studies on the registry are indexed under Skin Diseases, Infectious; 2 are open to participants now.
This study's enrollment of 143 is below the median of 161 across 37 interventional studies indexed under Skin Diseases, Infectious.
Browse Skin Diseases, Infectious studies →Paratek Pharmaceuticals Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets)
Drug: PTK 0796
Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution
Drug: linezolid · Drug: moxifloxacin
PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg
Also known as: omadacycline
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
Also known as: Zyvox™; Avelox™
moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution
Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the Case Report Form (CRF) check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: up to 14 days
Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)
Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: up to 14 days
Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: up to 14 days
Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)
Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
Time frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)
Number of Participants With the Indicated Type of Adverse Event (AE)
The assessment of safety was based mainly on the frequency of AEs, and summaries of vital signs and laboratory values (values classified as AE are captured in the AE module). An AE is defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, whether or not the event was considered causally related to the medical product. An AE could have been a new occurrence or an existing process that increased in intensity or frequency. AEs were deemed treatment-emergent if the start date was on or after the date of the first dose but was not present before that date or if the AE started before the date of the first dose and increased in severity on or after that date.
Time frame: from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days)
The study was designed to enroll adult participants with Complicated Skin and Skin Structure Infection (CSSI). Participants were stratified at study entry by type of infection (i.e., wound infection, cellulitis, major abscess).
| Milestone | Omadacycline | Linezolid |
|---|---|---|
| Started | 70 | 73 |
| Completed | 64 | 70 |
| Not completed | 6 | 3 |
| Withdrew: Withdrawal by subject | 4 | 1 |
| Withdrew: End of treatment/lost to follow-up | 0 | 1 |
| Withdrew: Adverse event/lost to follow-up | 1 | 0 |
| Withdrew: Exclusion condition | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the Case Report Form (CRF) check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 61 | 66 |
| Clinical failure | 1 | 3 |
| Clinical non-evaluable | 6 | 3 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 58 | 64 |
| Clinical failure | 2 | 3 |
| Clinical non-evaluable | 8 | 5 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 13 | 12 |
| Cinical failure | 0 | 1 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 38 | 44 |
| Clinical failure | 1 | 1 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 13 | 12 |
| Clinical failure | 0 | 1 |
Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 38 | 44 |
| Clinical failure | 1 | 1 |
The assessment of safety was based mainly on the frequency of AEs, and summaries of vital signs and laboratory values (values classified as AE are captured in the AE module). An AE is defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, whether or not the event was considered causally related to the medical product. An AE could have been a new occurrence or an existing process that increased in intensity or frequency. AEs were deemed treatment-emergent if the start date was on or after the date of the first dose but was not present before that date or if the AE started before the date of the first dose and increased in severity on or after that date.
| Participants | Omadacycline | Linezolid |
|---|---|---|
| Treatment-emergent adverse event (TEAE) | 56 | 58 |
| Study drug-related TEAE | 41 | 41 |
| AEs leading to study drug discontinuation | 2 | 0 |
Collected over from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days]). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omadacycline | 1/68 (1.5%) | 3/68 (4.4%) | 52/68 (76.5%) |
| Linezolid | 0/72 (0%) | 1/72 (1.4%) | 55/72 (76.4%) |
| Event | Omadacycline | Linezolid |
|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 1/68 | 0/72 |
| GastroenteritisInfections and infestations | 1/68 | 0/72 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/68 | 0/72 |
| DepressionPsychiatric disorders | 1/68 | 0/72 |
| CellulitisInfections and infestations | 0/68 | 1/72 |
| Event | Omadacycline | Linezolid |
|---|---|---|
| NauseaGastrointestinal disorders | 18/68 | 19/72 |
| HeadacheNervous system disorders | 16/68 | 5/72 |
| DiarrhoeaGastrointestinal disorders | 3/68 | 13/72 |
| VomitingGastrointestinal disorders | 6/68 | 11/72 |
| DizzinessNervous system disorders | 7/68 | 6/72 |
| ConstipationGastrointestinal disorders | 6/68 | 2/72 |
| Blood creatine phosphokinase increasedInvestigations | 6/68 | 2/72 |
| RashSkin and subcutaneous tissue disorders | 1/68 | 6/72 |
| Infusion site painGeneral disorders | 5/68 | 2/72 |
| InsomniaPsychiatric disorders | 2/68 | 5/72 |
Intent-to-Treat Population: all enrolled participants who received at least one dose of study medication
| Age, Customized(Participants) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| >=18 to <=44 years | 38 | 51 | 89 |
| >44 to <=64 | 26 | 20 | 46 |
| >64 | 4 | 1 | 5 |
| Sex: Female, Male(Participants) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| Female | 26 | 21 | 47 |
| Male | 42 | 51 | 93 |
| Race/Ethnicity, Customized(Participants) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| Caucasian | 56 | 61 | 117 |
| Black | 7 | 7 | 14 |
| Asian | 1 | 0 | 1 |
| Pacific Islander | 2 | 0 | 2 |
| Other; Not Specified | 2 | 4 | 6 |
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omadacycline
Paratek Pharmaceuticals Inc