A Phase 2 interventional study of PTK 0796 and Linezolid in Infectious Skin Disease and Bacterial Skin Disease, sponsored by Paratek Pharmaceuticals Inc. Completed at 11 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by Paratek Pharmaceuticals Inc · Phase 2, Interventional, and Treatment
A Phase II 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-0702 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.
37 studies on the registry are indexed under Skin Diseases, Bacterial; 2 are open to participants now.
This study's enrollment of 234 is close to the median of 249 across 29 interventional studies indexed under Skin Diseases, Bacterial.
Browse Skin Diseases, Bacterial 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.
Compared within Skin Diseases, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Skin Diseases, Infectious. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Drug: PTK 0796
Drug: Linezolid
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Microbiologic Response in the mITT Population
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
| Milestone | Omadacycline | Linezolid |
|---|---|---|
| Started | 118 | 116 |
| Completed | 107 | 98 |
| Not completed | 11 | 18 |
| Withdrew: Randomized, not treated | 7 | 8 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Treatment failure | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Missing reason | 0 | 1 |
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
| participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 75 | 59 |
| Clinical failure | 9 | 19 |
| Clinical failure: failure | 2 | 4 |
| Clinical failure: non-evaluable | 7 | 15 |
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
| participants | Omadacycline | Linezolid |
|---|---|---|
| Clinical success | 98 | 82 |
| Clinical failure | 2 | 6 |
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
| participants | Omadacycline | Linezolid |
|---|---|---|
| Microbiological success | 73 | 57 |
| Microbiological failure | 11 | 21 |
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
| participants | Omadacycline | Linezolid |
|---|---|---|
| Microbiological success | 73 | 57 |
| Microbiological failure | 4 | 6 |
Collected over from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omadacycline | 0/111 (0%) | 1/111 (0.9%) | 44/111 (39.6%) |
| Linezolid | 0/108 (0%) | 2/108 (1.9%) | 54/108 (50%) |
| Event | Omadacycline | Linezolid |
|---|---|---|
| Soft tissue infectionInfections and infestations | 0/111 | 1/108 |
| Wound infectionInfections and infestations | 0/111 | 1/108 |
| Confusional statePsychiatric disorders | 1/111 | 0/108 |
| Event | Omadacycline | Linezolid |
|---|---|---|
| NauseaGastrointestinal disorders | 13/111 | 8/108 |
| HeadacheNervous system disorders | 6/111 | 8/108 |
| Alanine aminotransferase (ALT) increasedInvestigations | 3/111 | 7/108 |
| DiarrhoeaGastrointestinal disorders | 3/111 | 6/108 |
| Aspartate aminotransaminase (AST) increasedInvestigations | 3/111 | 5/108 |
| DizzinessNervous system disorders | 4/111 | 5/108 |
| ConstipationGastrointestinal disorders | 5/111 | 2/108 |
| VomitingGastrointestinal disorders | 5/111 | 4/108 |
| FatigueGeneral disorders | 5/111 | 2/108 |
| RashSkin and subcutaneous tissue disorders | 5/111 | 0/108 |
Baseline data are reported for members of the Intent-to-Treat (ITT) Population, comprised of all enrolled participants who received at least 1 dose of study medication.
| Age, Continuous(years) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| Mean | 44.4 ± 14.06 | 45.4 ± 13.34 | 44.9 ± 13.69 |
| Sex: Female, Male(Participants) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| Female | 45 | 51 | 96 |
| Male | 66 | 57 | 123 |
| Race/Ethnicity, Customized(participants) | Omadacycline | Linezolid | Total |
|---|---|---|---|
| Caucasian | 97 | 99 | 196 |
| Black or African American | 8 | 6 | 14 |
| Asian Hawaiian or Other Pacific Islander | 5 | 1 | 6 |
| American Indian or Alaska Native | 0 | 1 | 1 |
| Recorded as Other | 1 | 1 | 2 |
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Studies of the drug tested here: Omadacycline
Paratek Pharmaceuticals Inc