A Phase 3 interventional study of Single-Dose IV Oritavancin Diphosphate and IV Vancomycin in Wound Infection, Abscess and Systemic Inflammation, sponsored by Melinta Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by Melinta Therapeutics, Inc. (part of CorMedix Therapeutics) · Phase 3, Interventional, and Treatment
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.
This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally.
In addition, this study will characterize the PK and PK/PD properties of a single 1200 mg IV dose of oritavancin and evaluate the potential health economic benefits offered by this dosing strategy.
270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.
This study's enrollment of 1,019 is above the median of 141 across 228 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Melinta Therapeutics, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
First submitted before Melinta Therapeutics, Inc. became part of CorMedix Therapeutics.
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.
Subjects may be included in the study if they meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days
ABSSSI due to or associated with any of the following:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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: Single-Dose IV Oritavancin Diphosphate
Drug: IV Vancomycin
Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
Early Clinical Response
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.
Time frame: 48-72 hours after the initation of study therapy
Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint)
Compared the clinical efficacy at the Post Therapy Evaluation of Oritavancin and Vancomycin based on the Investigator examination of the signs and symptoms of the primary ABSSSI; Investigator assessment of clinical cure is complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
Time frame: 7 to 14 days after end of therapy
>= 20% Reduction in Lesion Area
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration) based on changes in ABSSSI lesion size measurements from baseline.
Time frame: 48-72 hours after the initation of study therapy
| Milestone | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| Started | 509 | 510 |
| Modified intent to treat population | 503 | 502 |
| Completed | 455 | 446 |
| Not completed | 54 | 64 |
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.
| participants | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| Success | 403 | 416 |
| Failure | 100 | 86 |
Compared the clinical efficacy at the Post Therapy Evaluation of Oritavancin and Vancomycin based on the Investigator examination of the signs and symptoms of the primary ABSSSI; Investigator assessment of clinical cure is complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
| participants | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| Clinical Cure | 416 | 404 |
| Clinical Failure | 87 | 98 |
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration) based on changes in ABSSSI lesion size measurements from baseline.
| participants | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| Success | 432 | 428 |
| Failure | 71 | 74 |
Collected over Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-Dose 1200 mg Oritavancin | — | 22/503 (4.4%) | 272/503 (54.1%) |
| Vancomycin | — | 23/502 (4.6%) | 265/502 (52.8%) |
| Event | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| CellulitisInfections and infestations | 6/503 | 4/502 |
| OsteomyelitisInfections and infestations | 4/503 | 0/502 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/503 | 2/502 |
| Acute Myocardial InfarctionCardiac disorders | 0/503 | 2/502 |
| Skin InfectionInfections and infestations | 0/503 | 2/502 |
| Cardiac Failure CongestiveCardiac disorders | 1/503 | 1/502 |
| ConvulsionNervous system disorders | 1/503 | 1/502 |
| Abscess BacterialInfections and infestations | 0/503 | 1/502 |
| Arthritis BacterialInfections and infestations | 0/503 | 1/502 |
| Extradural AbscessInfections and infestations | 0/503 | 1/502 |
| Event | Single-Dose 1200 mg Oritavancin | Vancomycin |
|---|---|---|
| nauseaGastrointestinal disorders | 45/503 | 60/502 |
| headacheNervous system disorders | 35/503 | 28/502 |
| pruritusSkin and subcutaneous tissue disorders | 13/503 | 29/502 |
| vomitingGastrointestinal disorders | 22/503 | 28/502 |
| constipationGastrointestinal disorders | 14/503 | 17/502 |
| cellulitisInfections and infestations | 17/503 | 15/502 |
| alanine aminotransferase increasedInvestigations | 16/503 | 10/502 |
| infusion site phlebitisGeneral disorders | 16/503 | 5/502 |
| diarrheaGastrointestinal disorders | 13/503 | 15/502 |
| pyrexiaGeneral disorders | 15/503 | 11/502 |
Modified Intent to Treat (mITT) population
| Age, Continuous(years) | Single-Dose 1200 mg Oritavancin | Vancomycin | Total |
|---|---|---|---|
| Mean | 45.0 ± 13.40 | 44.4 ± 14.29 | 44.7 ± 13.85 |
| Sex: Female, Male(Participants) | Single-Dose 1200 mg Oritavancin | Vancomycin | Total |
|---|---|---|---|
| Female | 165 | 159 | 324 |
| Male | 338 | 343 | 681 |
The record gives a start of Dec 2010, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2021, 7 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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