Bacterial InfectionPhase 1NCT02268279
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
A Phase 1 study testing solithromycin in people with Bacterial Infection, run by Melinta Therapeutics, Inc. at 34 sites in 2 countries.
Trial summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17 Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- solithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Jan 2015to Oct 2016
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.
Who cannot join
- Serum creatinine >2 mg/dL
- Positive pregnancy test in females of childbearing potential
- History of intolerance or hypersensitivity to macrolide antibiotics
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States31 sites
Study site
Albany, New York, 12208
Study site
Albuquerque, New Mexico, 87131
Study site
Austin, Texas, 78723
Study site
Baltimore, Maryland, 21201
Study site
Brooklyn, New York, 11203
Study site
Chapel Hill, North Carolina, 27599
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44103
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242
Study site
Jacksonville, Florida, 32209
Study site
Little Rock, Arkansas, 72202
Study site
Louisville, Kentucky, 40202
Study site
Memphis, Tennessee, 38105-3678
Study site
Milwaukee, Wisconsin, 53226
Study site
Morgantown, West Virginia, 26506
Study site
Nashville, Tennessee, 37232
Study site
Omaha, Nebraska, 68198
Study site
Orange, California, 92868
Study site
Palo Alto, California, 94305
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 23298
Study site
San Diego, California, 92123
Study site
Seattle, Washington, 98105
Study site
Shreveport, Louisiana, 71103
Study site
Splendora, Texas, 77372
Study site
St Louis, Missouri, 63110
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43606
Study site
Wichita, Kansas, 67214
Bulgaria3 sites
Study site
Plovdiv, 4002
Study site
Rousse, 7002
Study site
Sofia, 1606
About this study
Official title: A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
- Conditions
- Bacterial Infection
- Being tested
- solithromycin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solithromycinDrug
Also called CEM-101
| Study group | Role | What they receive |
|---|---|---|
| solithromycin | Experimental | oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day Receives: Drug: solithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Measured: 5 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Michael Cohen-Wolkowiez, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268279
- Sponsor's protocol ID
- CE01-120
- Status last verified
- Jun 2017
- First submitted
- 15 Oct 2014
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
PubMed 31318840Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
PubMed 29891609
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection
- ClinicalTrials.gov ID
- NCT02268279
- Acronym / sponsor ID
- CE01-120
- Conditions
- Bacterial Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Oct 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.
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| solithromycin | Experimental | Drug: solithromycinoral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.
Key exclusion criteria (3 listed)
- Serum creatinine >2 mg/dL
- Positive pregnancy test in females of childbearing potential
- History of intolerance or hypersensitivity to macrolide antibiotics
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 |
|---|---|---|
| solithromycinAlso: CEM-101 | Drug | solithromycin |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Time frame: 5 to 7 days
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 9 Jun 2017.
- Derived from this study: PubMed 31318840Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
- Derived from this study: PubMed 29891609Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
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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.
Michael Cohen-Wolkowiez, MD principal investigator
Duke Clinical Research Institute
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing solithromycin in people with Bacterial Infection, run by Melinta Therapeutics, Inc. at 34 sites in 2 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 1 inclusion and 3 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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Bulgaria. 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?
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents (time frame: 5 to 7 days). 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 NCT02268279, which also lists 2 linked publications.
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 9 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.