Gonococcal InfectionNCT02961751
Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
A study testing Ciprofloxacin in people with Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gonococcal Infection
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Oct 2016to 4 Jan 2019
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give voluntary written informed consent before any study related procedure is performed.
- 18 years or older, on the day of enrollment.
- Untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.
- Subjects must have gyrA serine 91 genotype detected for N. gonorrhoeae from at least one non-pharyngeal site.
- Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-10) is complete.
- Women of childbearing potential must have no vaginal intercourse 14 days before enrollment or use an effective birth control method for 30 days before enrollment and agree to continue through visit 2.
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- A woman is considered of childbearing potential unless post-menopausal (greater than 2 years) or surgically sterilized (tubal ligation greater than 1 year, bilateral oophorectomy, or hysterectomy).
- Acceptable birth control methods for the purposes of this study may include abstinence from intercourse with a male partner, monogamous relationship with vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly.
- Able to swallow pills.
- Willing to comply with protocol requirements, including availability for follow-up for the duration of the study.
- Agree to avoid systemic or intravaginal antibiotics with activity against N. gonorrhoeae from enrollment through Visit 2 (Day 5-10). Topical and intravaginal antifungals are permitted.
- Agree to avoid magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, up to 2 hours after receipt of study drug.
Who cannot join
- Known renal insufficiency from clinical history.
- Use of systemic or intravaginal antibiotics with potential activity against N. gonorrhoeae within 30 days prior to study drug administration.
- Topical and intravaginal antifungals are permitted.
- Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.
- Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.
- Pregnant or breastfeeding.
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- Clinical diagnosis of pelvic inflammatory disease or genital ulcer.
- Confirmed or suspected complicated or systemic gonococcal infection, such as abdominal pain, testicular pain, epididymitis, orchitis, arthritis, or endocarditis.
- Receipt of magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, within 6 hours before receipt of study drug.
- Mutant N. gonorrhoeae gyrA serine 91 genotype from any anatomic site, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.
- Known allergy or history of adverse reaction to ciprofloxacin.
- Known allergy to quinolones.
- Previous enrollment in this study.
- Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Mississippi - Infectious Diseases
Jackson, Mississippi, 39202
AIDS Healthcare Foundation Wellness Center - Hollywood
Los Angeles, California, 90027
Los Angeles Lesbian Gay Bisexual/Transgender Center
Los Angeles, California, 90028-6213
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70119
Philadelphia Department of Public Health - Health Center 1
Philadelphia, Pennsylvania, 19146
University of California, San Diego - Antiviral Research Center
San Diego, California, 92103-8208
University of California, San Diego Health - Owen Clinic
San Diego, California, 92103
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, 94103-4030
Whitman-Walker Health
Washington D.C., District of Columbia, 20005
About this study
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.
Read the detailed description
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype. The secondary objectives of the study are to 1) investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infection by anatomic site and 2) to determine the sensitivity of the gyrA assay for detection of ciprofloxacin-susceptible N. gonorrhoeae infections.
- Conditions
- Gonococcal Infection
- Being tested
- Ciprofloxacin
- Keywords
- Ciprofloxacin-susceptibility, Efficacy, Gyrase A Assay, Neisseria gonorrhoeae
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Other | One dose of directly-observed ciprofloxacin 500 mg administered orally. N=381 Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.
Measured: Day 5 through Day 10
Secondary outcomes (7)
The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the urogenital tract were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline
Measured: Day 5 through Day 10
The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the rectum were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline
Measured: Day 5 through Day 10
The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the throat were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline
Measured: Day 5 through Day 10
The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each urethral sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.
Measured: Day 1
The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each cervical sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.
Measured: Day 1
The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each rectal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.
Measured: Day 1
The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each pharyngeal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start19 Oct 2016
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
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 Gonococcal InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961751
- Sponsor's protocol ID
- 15-0090
- Status last verified
- 4 Dec 2019
- First submitted
- 9 Nov 2016
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klausner JD, Bristow CC, Soge OO, Shahkolahi A, Waymer T, Bolan RK, Philip SS, Asbel LE, Taylor SN, Mena LA, Goldstein DA, Powell JA, Wierzbicki MR, Morris SR. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study. Clin Infect Dis. 2021 Jul 15;73(2):298-303. doi: 10.1093/cid/ciaa596.
PubMed 32766725
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
- ClinicalTrials.gov ID
- NCT02961751
- Acronym / sponsor ID
- 15-0090
- Conditions
- Gonococcal Infection
- Keywords
- Ciprofloxacin-susceptibility, Efficacy, Gyrase A Assay, Neisseria gonorrhoeae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.
Detailed description
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype. The secondary objectives of the study are to 1) investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infection by anatomic site and 2) to determine the sensitivity of the gyrA assay for detection of ciprofloxacin-susceptible N. gonorrhoeae infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Other | Drug: CiprofloxacinOne dose of directly-observed ciprofloxacin 500 mg administered orally. N=381 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to give voluntary written informed consent before any study related procedure is performed.
- 18 years or older, on the day of enrollment.
- Untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.
- Subjects must have gyrA serine 91 genotype detected for N. gonorrhoeae from at least one non-pharyngeal site.
- Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-10) is complete.
Key exclusion criteria (14 listed)
- Known renal insufficiency from clinical history.
- Use of systemic or intravaginal antibiotics with potential activity against N. gonorrhoeae within 30 days prior to study drug administration.
- Topical and intravaginal antifungals are permitted.
- Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.
- Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.
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 |
|---|---|---|
| CiprofloxacinDirectly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food. | Drug | Ciprofloxacin |
Primary outcome
The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure
Time frame: Day 5 through Day 10
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.
7 secondary outcomes
The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Time frame: Day 5 through Day 10
The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Time frame: Day 5 through Day 10
The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae
Time frame: Day 5 through Day 10
The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Time frame: Day 1
The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Time frame: Day 1
The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Time frame: Day 1
The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32766725Klausner JD, Bristow CC, Soge OO, Shahkolahi A, Waymer T, Bolan RK, Philip SS, Asbel LE, Taylor SN, Mena LA, Goldstein DA, Powell JA, Wierzbicki MR, Morris SR. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study. Clin Infect Dis. 2021 Jul 15;73(2):298-303. doi: 10.1093/cid/ciaa596.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofloxacin in people with Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 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 12 inclusion and 14 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2020). 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?
The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure (time frame: Day 5 through Day 10). 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 NCT02961751, 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 25 Aug 2020.