Gram-positive Bacterial InfectionsPhase 1NCT02134301
Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections
A Phase 1 study testing Oritavancin in people with Gram-positive Bacterial Infections, run by Melinta Therapeutics, LLC at 8 sites in United States.
Trial summary
The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants <18 years old with a confirmed or suspected bacterial infection. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gram-positive Bacterial Infections
- What is being tested?
- Oritavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2014to 4 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females <18 years of age.
- Neonates must be at least 34 weeks post-conception age.
- Parent or legal guardian has given informed consent, as appropriate; and pediatric participant has given verbal assent where appropriate.
- Suspected or diagnosed Gram-positive bacterial infection for which the participant is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics.
- Intravenous access to administer study drug.
- The participant will be observed in the emergency room or hospital for at least 1 hour after the study drug infusion is completed.
Who cannot join
- Septic shock or acute haemodynamic instability.
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, dalbavancin, televancin, or teicoplanin) or any of their excipients.
- Participants who have taken vancomycin, telavancin, teicoplanin or other glycopeptide within 24 hours of screening or who are anticipated to need these drugs within 48 hours after administration of study drug. Participants who have taken dalbavancin are excluded if taken within the previous 2 weeks or who are anticipated to need dalbavancin within 48 hours after administration of study drug.
- Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception or female participants of childbearing who are lactating or have a positive pregnancy test result at screening.
- Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period.
- Any surgical or medical condition which, in the opinion of the investigator, would put the participant at increased risk or is likely to interfere with study procedures or PK of the study drug.
Show all 9Show fewer
- Participants whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study.
- Treatment with investigational medicinal product or investigational device within 30 days (or 5 times the half-life of the investigational medicine, whichever is longer) before enrollment and for the duration of the study.
- Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, metabolic or cardiovascular disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Univ of Louisville, Norton Children's Research Institute
Louisville, Kentucky, 40202
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Children's Hospital of Orange County
Orange, California, 92868
Rady Children's Hospital
San Diego, California, 92123
Toledo Children's Hospital
Toledo, Ohio, 43606
UCLA Harbor Medical Center
Torrance, California, 90502
About this study
Official title: An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections
The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants <18 years old with a confirmed or suspected bacterial infection.
Read the detailed description
This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric participants (<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric participants requiring peri-operative prophylactic antibiotics. Approximately 54 participants will be enrolled at 5-10 United States centers. This study will include 5 age cohorts and participants will be entered in a stepwise approach starting with the older age cohort (12 to <18 years). The starting dose will be intravenous (IV) oritavancin 15 milligrams/kilogram. The safety, tolerability and PK data will be reviewed at the completion of each cohort to ensure safety and determine the appropriate dose for the next age cohort. At least 8 participants will be enrolled in each cohort except for the birth to <3 month age cohort which will have at least 16 participants enrolled. Three PK samples will be collected over 14 days. The safety follow-up will complete with a 60-day phone call to the caregiver.
- Conditions
- Gram-positive Bacterial Infections
- Being tested
- Oritavancin
- Keywords
- Oritavancin, Pediatrics, Gram-positive, Bacterial Infection, Confirmed, Suspected
- Medical subject headings
- Gram-Positive Bacterial Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Experimental | Single-dose IV Oritavancin Diphosphate Receives: Drug: Oritavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
PK parameters (AUC)
Measured: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
Secondary outcomes (2)
Pharmacokinetic Parameters
PK parameters (Cmax, half-life, tmax, volume of distribution and clearance)
Measured: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
Safety Endpoint
Safety of oritavancin assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events (SAEs) up to 60 days following termination of the study drug infusion.
Measured: Up to Day 60 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2014
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-positive Bacterial InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134301
- Sponsor's protocol ID
- TMC-ORI-11-01
- Other IDs
- 2013-005415-26
- Status last verified
- Dec 2025
- First submitted
- 7 May 2014
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections
- ClinicalTrials.gov ID
- NCT02134301
- Acronym / sponsor ID
- TMC-ORI-11-01
- Conditions
- Gram-positive Bacterial Infections
- Keywords
- Oritavancin, Pediatrics, Gram-positive, Bacterial Infection, Confirmed, Suspected
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Melinta Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants <18 years old with a confirmed or suspected bacterial infection.
Detailed description
This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric participants (<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric participants requiring peri-operative prophylactic antibiotics. Approximately 54 participants will be enrolled at 5-10 United States centers. This study will include 5 age cohorts and participants will be entered in a stepwise approach starting with the older age cohort (12 to <18 years). The starting dose will be intravenous (IV) oritavancin 15 milligrams/kilogram. The safety, tolerability and PK data will be reviewed at the completion of each cohort to ensure safety and determine the appropriate dose for the next age cohort. At least 8 participants will be enrolled in each cohort except for the birth to <3 month age cohort which will have at least 16 participants enrolled. Three PK samples will be collected over 14 days. The safety follow-up will complete with a 60-day phone call to the caregiver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | Experimental | Drug: OritavancinSingle-dose IV Oritavancin Diphosphate |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females <18 years of age.
- Neonates must be at least 34 weeks post-conception age.
- Parent or legal guardian has given informed consent, as appropriate; and pediatric participant has given verbal assent where appropriate.
- Suspected or diagnosed Gram-positive bacterial infection for which the participant is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics.
- Intravenous access to administer study drug.
Key exclusion criteria (9 listed)
- Septic shock or acute haemodynamic instability.
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, dalbavancin, televancin, or teicoplanin) or any of their excipients.
- Participants who have taken vancomycin, telavancin, teicoplanin or other glycopeptide within 24 hours of screening or who are anticipated to need these drugs within 48 hours after administration of study drug. Participants who have taken dalbavancin are excluded if taken within the previous 2 weeks or who are anticipated to need dalbavancin within 48 hours after administration of study drug.
- Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception or female participants of childbearing who are lactating or have a positive pregnancy test result at screening.
- Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period.
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 |
|---|---|---|
| Oritavancin | Drug | Oritavancin |
Primary outcome
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
Time frame: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
PK parameters (AUC)
2 secondary outcomes
Pharmacokinetic Parameters
Time frame: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
Safety Endpoint
Time frame: Up to Day 60 post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Gram-positive Bacterial Infections
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
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.
Study Director study director
Melinta Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oritavancin in people with Gram-positive Bacterial Infections, run by Melinta Therapeutics, LLC at 8 sites in United States.
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 6 inclusion and 9 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC]) (time frame: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.