GonorrheaPhase 3NCT02015637
Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
A Phase 3 study testing Delafloxacin and Ceftriaxone in people with Gonorrhea, run by Melinta Therapeutics, Inc. at 25 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Gonorrhea
- What is being tested?
- Delafloxacin and Ceftriaxone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 25 sitesUnited States
- Study dates
- 23 Jan 2014to 10 Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a male or female 15 years of age or older.
- Subject must have had 1 or more of the following occur:
- gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days
- unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea,
- gram-negative present in urogenital gram strain or male subject must present with purulent urethritis or a female subject with must present with mucopurulent cervical discharge
- Subject agrees to avoid unprotected sexual contact in order to minimize the risk of gonorrhea reinfection
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- Subject must be in good health (ie, based on medical history), as determined by the investigator.
- In the opinion of the investigator, the subject must be able and willing to comply with protocol requirements. The subject must agree to provide reliable, verifiable contact information and agree to return for the Test-of-Cure Visit.
- If a subject's age is 15 years to less than the legal age of consent,a written, voluntarily signed assent must be obtained from the subject and a written, voluntarily signed informed consent must be signed by the subject's parent or legal guardian before the initiation of any study related procedures, unless the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determines that parent/legal guardian consent is not required.
Who cannot join
- Confirmed, or suspected, complicated or systemic gonococcal infection, such as pelvic inflammatory disease, arthritis, or endocarditis.
- Subject has taken one of the following products within 6 hours of the Entry Visit that may interfere with the absorption of a quinolone antibiotic: magnesium/aluminum antacids; sucralfate; Videx® (didanosine) chewable/buffered tablets; other highly buffered drugs; or other products containing calcium, iron, or zinc.
- Use of systemic or intravaginal antibiotics that are potentially effective against gonorrhea 4 weeks prior to study drug administration.
- Subjects with a current or prior history of seizures, and subjects being treated with drugs that are known to have a sizable potential of or reduce the threshold for inducing seizures (eg, bupropion, theophylline, and tricyclic and tetracyclic antidepressants).
- Current use of systemic corticosteroid or immunosuppressive drugs.
- Known significant immunosuppression (eg, cluster of differentiation (CD4) cell count <200/mm3 or absolute neutrophil count <500/mL).
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- Cytotoxic chemotherapy or radiation therapy during the previous 3 months.
- Subject is co-infected with an additional sexually transmitted disease (STD) for which treatment cannot be safely deferred until after the Test-of-Cure Visit unless the treatment is not potentially effective against gonorrhea.
- Subject has used an investigational drug or product within 30 days before study drug dosing.
- Medical history of Type 1 hypersensitivity to antibiotics of the quinolone or cephalosporin classes.
- Hysterectomized subjects without a cervix are ineligible.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Melinta 304 Study
Atlanta, Georgia, 30308
Melinta 304 Study
Birmingham, Alabama, 35294
Melinta 304 Study Site
Brooklyn, New York, 11203
Melinta 304 Study
Brooklyn, New York, 11203
Melinta 304 Study Site
Chula Vista, California, 90911
Melinta 304 Study Site
Cleveland, Ohio, 44108
Melinta 304 Study Site
Columbus, Ohio, 43231
Melinta 304 Study
Decatur, Georgia, 30033
Melinta 304 Study Site
Durham, North Carolina, 27701
Melinta 304 Study
Erie, Pennsylvania, 16507
Melinta 304 Study Site
Greensboro, North Carolina, 27405
Melinta 304 Study Site
Houston, Texas, 77011
Melinta 304 Study Site
Indianapolis, Indiana, 46202
Melinta 304 Study Site
La Mesa, California, 91942
Melinta 304 Study Site
Las Vegas, Nevada, 89109
Melinta 304 Study Site
Los Angeles, California, 90069
Melinta 304 Study Site
New Orleans, Louisiana, 70112
Melinta 304 Study Site
New York, New York, 10018
Melinta 304 Study Site
Omaha, Nebraska, 68114
Melinta 304 Study Site
Philadelphia, Pennsylvania, 191007
Melinta 304 Study Site
Pittsburgh, Pennsylvania, 15213
Melinta 304 Study Site
Portland, Oregon, 97204
Melinta 304 Study Site
San Francisco, California, 94103
Melinta 304 Study Site
Seattle, Washington, 98104
Melinta 304 Study Site
The Bronx, New York, 100461
About this study
Official title: A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.
- Conditions
- Gonorrhea
- Being tested
- Delafloxacin, Ceftriaxone
- Keywords
- Gonorrhea, N. gonorrhoeae, bacterial infection, Anti-Infective Agents, Anti-Bacterial Agents
- Medical subject headings
- Gonorrhea, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelafloxacinDrug
single dose
CeftriaxoneDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Delafloxacin | Experimental | 900mg orally (2 x 450 mg tablets) administered once Receives: Drug: Delafloxacin |
| ceftriaxone | Active comparator | Ceftriaxone 250 mg intramuscular injection administered once Receives: Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Measured: Day 7 (± 3 days)
Secondary outcomes (1)
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Measured: Day 7 (± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start23 Jan 2014
- Primary completionNov 2014
- Study completion10 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue Cammarata, MD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015637
- Sponsor's protocol ID
- ML-3341-304
- Status last verified
- May 2018
- First submitted
- 13 Dec 2013
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hook EW 3rd, Golden MR, Taylor SN, Henry E, Tseng C, Workowski KA, Swerdlow J, Nenninger A, Cammarata S. Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study. Sex Transm Dis. 2019 May;46(5):279-286. doi: 10.1097/OLQ.0000000000000971.
PubMed 30985632
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea
- ClinicalTrials.gov ID
- NCT02015637
- Acronym / sponsor ID
- ML-3341-304
- Conditions
- Gonorrhea
- Keywords
- Gonorrhea, N. gonorrhoeae, bacterial infection, Anti-Infective Agents, Anti-Bacterial Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- 10 Dec 2014 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 26 Apr 2018
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 study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delafloxacin | Experimental | Drug: Delafloxacin900mg orally (2 x 450 mg tablets) administered once |
| ceftriaxone | Active comparator | Drug: CeftriaxoneCeftriaxone 250 mg intramuscular injection administered once |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is a male or female 15 years of age or older.
- Subject must have had 1 or more of the following occur:
- Subject agrees to avoid unprotected sexual contact in order to minimize the risk of gonorrhea reinfection
- Subject must be in good health (ie, based on medical history), as determined by the investigator.
- In the opinion of the investigator, the subject must be able and willing to comply with protocol requirements. The subject must agree to provide reliable, verifiable contact information and agree to return for the Test-of-Cure Visit.
Key exclusion criteria (11 listed)
- Confirmed, or suspected, complicated or systemic gonococcal infection, such as pelvic inflammatory disease, arthritis, or endocarditis.
- Subject has taken one of the following products within 6 hours of the Entry Visit that may interfere with the absorption of a quinolone antibiotic: magnesium/aluminum antacids; sucralfate; Videx® (didanosine) chewable/buffered tablets; other highly buffered drugs; or other products containing calcium, iron, or zinc.
- Use of systemic or intravaginal antibiotics that are potentially effective against gonorrhea 4 weeks prior to study drug administration.
- Subjects with a current or prior history of seizures, and subjects being treated with drugs that are known to have a sizable potential of or reduce the threshold for inducing seizures (eg, bupropion, theophylline, and tricyclic and tetracyclic antidepressants).
- Current use of systemic corticosteroid or immunosuppressive drugs.
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 |
|---|---|---|
| Delafloxacinsingle dose | Drug | Delafloxacin |
| Ceftriaxonesingle dose | Drug | ceftriaxone |
Primary outcome
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
Time frame: Day 7 (± 3 days)
Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
1 secondary outcome
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Time frame: Day 7 (± 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30985632Hook EW 3rd, Golden MR, Taylor SN, Henry E, Tseng C, Workowski KA, Swerdlow J, Nenninger A, Cammarata S. Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study. Sex Transm Dis. 2019 May;46(5):279-286. doi: 10.1097/OLQ.0000000000000971.
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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.
Sue Cammarata, MD study director
Melinta Therapeutics, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delafloxacin and Ceftriaxone in people with Gonorrhea, run by Melinta Therapeutics, Inc. at 25 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population (time frame: Day 7 (± 3 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 NCT02015637, 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 20 Jun 2018.