Uncomplicated Urogenital GonorrheaPhase 2NCT01591447
Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
A Phase 2 study testing solithromycin and Solithromycin (CEM-101) in people with Uncomplicated Urogenital Gonorrhea, run by Melinta Therapeutics, Inc. at 2 sites in United States.
Trial summary
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Uncomplicated Urogenital Gonorrhea
- What is being tested?
- solithromycin and Solithromycin (CEM-101)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jun 2013
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
- Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
Who cannot join
- Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
- Known HIV, chronic hepatitis B, or hepatitis C infection.
- Known concomitant infection which would require additional systemic antibiotics.
- Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
- Current use of corticosteroid drugs or other immunosuppressive therapy.
- Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
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- Known significant renal, hepatic, or hematologic impairment.
- History of intolerance or hypersensitivity to macrolide antibiotics.
- Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy <30 days).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jefferson County Department of Health
Birmingham, Alabama, 35233
Harborview STD Clinic
Seattle, Washington, 98104
About this study
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
- Conditions
- Uncomplicated Urogenital Gonorrhea
- Being tested
- solithromycin, Solithromycin (CEM-101)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solithromycinDrug
A single oral dose of 1200 mg solithromycin (CEM-101)
Solithromycin (CEM-101)Drug
A single oral dose of 1000 mg solithromycin
| Study group | Role | What they receive |
|---|---|---|
| Solithromycin (CEM-101) | Experimental | A single oral dose of 1200 mg solithromycin Receives: Drug: solithromycin |
| Solithromycin 1000 mg | Experimental | A single oral dose of 1000 mg solithromycin Receives: Drug: Solithromycin (CEM-101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
Measured: 3 to 9 days after study drug dosing
Secondary outcomes (5)
Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea
Adverse event reporting, clinical laboratory evaluations
Measured: One day after study drug dosing, and 3 to 9 days after study drug dosing
The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)
Measured: 3 to 9 days after study drug dosing
Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
Measured: 3 to 9 days after study drug dosing
Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
Measured: 3 to 9 days after study drug dosing
In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated
Measured: Baseline and (if applicable) 3 to 9 days after study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Urogenital GonorrheaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward W Hook, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591447
- Sponsor's protocol ID
- CE01-202
- Status last verified
- Mar 2017
- First submitted
- 2 May 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hook EW 3rd, Golden M, Jamieson BD, Dixon PB, Harbison HS, Lowens S, Fernandes P. A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea. Clin Infect Dis. 2015 Oct 1;61(7):1043-8. doi: 10.1093/cid/civ478. Epub 2015 Jun 18.
PubMed 26089222
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea
- ClinicalTrials.gov ID
- NCT01591447
- Acronym / sponsor ID
- CE01-202
- Conditions
- Uncomplicated Urogenital Gonorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 May 2012 (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.
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solithromycin (CEM-101) | Experimental | Drug: solithromycinA single oral dose of 1200 mg solithromycin |
| Solithromycin 1000 mg | Experimental | Drug: Solithromycin (CEM-101)A single oral dose of 1000 mg solithromycin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
- Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
Key exclusion criteria (9 listed)
- Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
- Known HIV, chronic hepatitis B, or hepatitis C infection.
- Known concomitant infection which would require additional systemic antibiotics.
- Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
- Current use of corticosteroid drugs or other immunosuppressive therapy.
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 |
|---|---|---|
| solithromycinA single oral dose of 1200 mg solithromycin (CEM-101) | Drug | Solithromycin (CEM-101) |
| Solithromycin (CEM-101)A single oral dose of 1000 mg solithromycin | Drug | Solithromycin 1000 mg |
Primary outcome
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
Time frame: 3 to 9 days after study drug dosing
5 secondary outcomes
Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea
Time frame: One day after study drug dosing, and 3 to 9 days after study drug dosing
The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)
Time frame: 3 to 9 days after study drug dosing
Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
Time frame: 3 to 9 days after study drug dosing
Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
Time frame: 3 to 9 days after study drug dosing
In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated
Time frame: Baseline and (if applicable) 3 to 9 days after study drug dosing
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 3 Mar 2017.
- Derived from this study: PubMed 26089222Hook EW 3rd, Golden M, Jamieson BD, Dixon PB, Harbison HS, Lowens S, Fernandes P. A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea. Clin Infect Dis. 2015 Oct 1;61(7):1043-8. doi: 10.1093/cid/civ478. Epub 2015 Jun 18.
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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.
Edward W Hook, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solithromycin and Solithromycin (CEM-101) in people with Uncomplicated Urogenital Gonorrhea, run by Melinta Therapeutics, Inc. at 2 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 3 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative (time frame: 3 to 9 days after study drug dosing). 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 NCT01591447, which also lists 1 linked publication.
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 3 Mar 2017.