UrethritisPhase 3NCT00358462
Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
A Phase 3 study testing Azithromycin and Doxycycline in people with Urethritis, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle… Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Urethritis
- What is being tested?
- Azithromycin and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2011
- 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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has a visible urethral discharge or greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per high power field on a Gram-stained slide of a urethral swab sample
- Possesses and is willing to disclose valid contact information for follow-up
- English-speaking
- Gives informed consent
- Exhibits understanding of study procedures
- Exhibits ability to comply with study procedures for the entire length of the study
Who cannot join
- Has previously participated in this study
- Has taken antibiotics within the prior month
- Has known allergies to tetracyclines or azithromycin
- Is being treated with any of the following: warfarin, ergot derivatives, pimozide (Orap), propafenone (Rytmonorm, Rythmol), disopyramide (Norpace, Rythmodan), rifampin, digoxin, isotretinoin, or methotrexate
- Has received a kidney, heart, or lung transplant.
- Is undertaking concomitant systemic steroid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis
The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.
Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).
Read more
Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.
Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
Read the detailed description
OBJECTIVES
The primary objective of this study is to determine the relative effectiveness of azithromycin and doxycycline in eradicating Mycoplasma genitalium and Ureaplasmas among men with nongonococcal urethritis (NGU).
Secondary objectives of this study are to:
- determine the sensitivity of persisting organisms to azithromycin and doxycycline by performing minimum inhibitory concentration (MIC) testing
- determine the relationship between persistence/recurrence of clinical signs and persistent/recurrent detection of M. genitalium and Ureaplasmas among men with NGU treated with azithromycin or doxycycline, measured by follow-up clinical exams and repeated assays performed on specimens collected at follow-up study visits
STUDY DESCRIPTION
1200 men with NGU, ages 16 and older, will be enrolled in a randomized double-blinded treatment trial. Urine samples, oral swabs, and urethral swabs will be obtained from each subject at the initial clinic visit. Urine specimens will be tested for M. genitalium and Ureaplasma. Study participants will be randomly assigned to receive one of two pre-packaged treatments: active doxycycline plus placebo azithromycin or active azithromycin plus placebo doxycycline. Subjects will complete a questionnaire, and will be given a simple standardized log in which they will be asked to keep track of adherence to the study drug, record solicited adverse events, note when symptoms disappear and/or reappear, and document sexual activity between study visits.
Subjects who test positive for M. genitalium or Ureaplasmas at the initial clinic visit will be asked to return for at least two follow-up study visits: at approximately 3 and 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis and re-tested for M. genitalium and Ureaplasmas. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visits will receive a blinded treatment packet containing the alternate medication, or will be offered open-label moxifloxacin if the alternate treatment regimen was administered at the prior follow-up study visit. If additional treatment is administered at the 6-week follow-up study visit, a fourth study visit will be scheduled to occur approximately 9 or 10 weeks following the initial clinic visit.
Study participants who were negative for M. genitalium and Ureaplasma at enrollment will be asked to return for evaluation for a single follow-up study visit, approximately 3 weeks after the initial clinic visit. At this visit they will complete the follow-up questionnaire and provide specimens for future testing.
- Conditions
- Urethritis
- Being tested
- Azithromycin, Doxycycline
- Keywords
- NGU, M genitalium, Ureaplasma, azithromycin, doxycycline
- Medical subject headings
- Urethritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax, Zmax
two 500mg tablets or four 250mg tablets administered as a single dose
DoxycyclineDrug
Also called Doryx, Doxychel, Monodox, Oracea
one 100mg capsule administered twice daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Active azithromycin+placebo doxycycline | Active comparator | Active azithromycin (1g) and placebo doxycycline Receives: Drug: Azithromycin |
| Active doxycycline+placebo azithromycin | Active comparator | Active doxycycline and placebo azithromycin Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)
Measured: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit
Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit
Measured: 3 weeks (allowable window 2-5)
Secondary outcomes (6)
Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit
Proportion of men with M. genitalium at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.
Measured: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit
Proportion of men with Ureaplasma urealyticum at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.
Measured: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin
In vitro susceptibiities of M. genitalium to azithromycin
Measured: baseline
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline
In vitro susceptibilities of M. genitalium to doxycycline
Measured: baseline
Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2
In vitro susceptibilities of U. urealyticum biovar 2
Measured: baseline
Minimum Inhibitory Concentrations (MIC) of U. Parvum
In vitro susceptibilities of U. parvum
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startJan 2007
- Primary completionNov 2011
- Study completionNov 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for UrethritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Manhart, University of Washington
- Investigators
- Lisa E Manhart, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358462
- Sponsor's protocol ID
- 26995
- Other IDs
- 05-0143 (protocol number), U19AI031448, R01AI072728
- Status last verified
- Jul 2018
- First submitted
- 27 Jul 2006
- Last updated
- 15 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Khosropour CM, Manhart LE, Gillespie CW, Lowens MS, Golden MR, Jensen NL, Kenny GE, Totten PA. Efficacy of standard therapies against Ureaplasma species and persistence among men with non-gonococcal urethritis enrolled in a randomised controlled trial. Sex Transm Infect. 2015 Aug;91(5):308-13. doi: 10.1136/sextrans-2014-051859. Epub 2015 Jan 23.
PubMed 25616607Khosropour CM, Manhart LE, Colombara DV, Gillespie CW, Lowens MS, Totten PA, Golden MR, Simoni J. Suboptimal adherence to doxycycline and treatment outcomes among men with non-gonococcal urethritis: a prospective cohort study. Sex Transm Infect. 2014 Feb;90(1):3-7. doi: 10.1136/sextrans-2013-051174. Epub 2013 Oct 8.
PubMed 24106340Manhart LE, Gillespie CW, Lowens MS, Khosropour CM, Colombara DV, Golden MR, Hakhu NR, Thomas KK, Hughes JP, Jensen NL, Totten PA. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial. Clin Infect Dis. 2013 Apr;56(7):934-42. doi: 10.1093/cid/cis1022. Epub 2012 Dec 7.
PubMed 23223595
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis
- ClinicalTrials.gov ID
- NCT00358462
- Acronym / sponsor ID
- 26995
- Conditions
- Urethritis
- Keywords
- NGU, M genitalium, Ureaplasma, azithromycin, doxycycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Jul 2006 (estimated)
- Results
- Posted 8 Mar 2013
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 find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.
Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).
Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.
Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
Detailed description
OBJECTIVES
The primary objective of this study is to determine the relative effectiveness of azithromycin and doxycycline in eradicating Mycoplasma genitalium and Ureaplasmas among men with nongonococcal urethritis (NGU).
Secondary objectives of this study are to:
- determine the sensitivity of persisting organisms to azithromycin and doxycycline by performing minimum inhibitory concentration (MIC) testing
- determine the relationship between persistence/recurrence of clinical signs and persistent/recurrent detection of M. genitalium and Ureaplasmas among men with NGU treated with azithromycin or doxycycline, measured by follow-up clinical exams and repeated assays performed on specimens collected at follow-up study visits
STUDY DESCRIPTION
1200 men with NGU, ages 16 and older, will be enrolled in a randomized double-blinded treatment trial. Urine samples, oral swabs, and urethral swabs will be obtained from each subject at the initial clinic visit. Urine specimens will be tested for M. genitalium and Ureaplasma. Study participants will be randomly assigned to receive one of two pre-packaged treatments: active doxycycline plus placebo azithromycin or active azithromycin plus placebo doxycycline. Subjects will complete a questionnaire, and will be given a simple standardized log in which they will be asked to keep track of adherence to the study drug, record solicited adverse events, note when symptoms disappear and/or reappear, and document sexual activity between study visits.
Subjects who test positive for M. genitalium or Ureaplasmas at the initial clinic visit will be asked to return for at least two follow-up study visits: at approximately 3 and 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis and re-tested for M. genitalium and Ureaplasmas. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visits will receive a blinded treatment packet containing the alternate medication, or will be offered open-label moxifloxacin if the alternate treatment regimen was administered at the prior follow-up study visit. If additional treatment is administered at the 6-week follow-up study visit, a fourth study visit will be scheduled to occur approximately 9 or 10 weeks following the initial clinic visit.
Study participants who were negative for M. genitalium and Ureaplasma at enrollment will be asked to return for evaluation for a single follow-up study visit, approximately 3 weeks after the initial clinic visit. At this visit they will complete the follow-up questionnaire and provide specimens for future testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active azithromycin+placebo doxycycline | Active comparator | Drug: AzithromycinActive azithromycin (1g) and placebo doxycycline |
| Active doxycycline+placebo azithromycin | Active comparator | Drug: DoxycyclineActive doxycycline and placebo azithromycin |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has a visible urethral discharge or greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per high power field on a Gram-stained slide of a urethral swab sample
- Possesses and is willing to disclose valid contact information for follow-up
- English-speaking
- Gives informed consent
- Exhibits understanding of study procedures
Key exclusion criteria (6 listed)
- Has previously participated in this study
- Has taken antibiotics within the prior month
- Has known allergies to tetracyclines or azithromycin
- Is being treated with any of the following: warfarin, ergot derivatives, pimozide (Orap), propafenone (Rytmonorm, Rythmol), disopyramide (Norpace, Rythmodan), rifampin, digoxin, isotretinoin, or methotrexate
- Has received a kidney, heart, or lung transplant.
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 |
|---|---|---|
| AzithromycinAlso: Zithromax, Zmaxtwo 500mg tablets or four 250mg tablets administered as a single dose | Drug | Active azithromycin+placebo doxycycline |
| DoxycyclineAlso: Doryx, Doxychel, Monodox, Oraceaone 100mg capsule administered twice daily for seven days | Drug | Active doxycycline+placebo azithromycin |
Primary outcome
mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
Time frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)
mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit
Time frame: 3 weeks (allowable window 2-5)
Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit
6 secondary outcomes
Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit
Time frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit
Time frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin
Time frame: baseline
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline
Time frame: baseline
Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2
Time frame: baseline
Minimum Inhibitory Concentrations (MIC) of U. Parvum
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25616607Khosropour CM, Manhart LE, Gillespie CW, Lowens MS, Golden MR, Jensen NL, Kenny GE, Totten PA. Efficacy of standard therapies against Ureaplasma species and persistence among men with non-gonococcal urethritis enrolled in a randomised controlled trial. Sex Transm Infect. 2015 Aug;91(5):308-13. doi: 10.1136/sextrans-2014-051859. Epub 2015 Jan 23.
- Derived from this study: PubMed 24106340Khosropour CM, Manhart LE, Colombara DV, Gillespie CW, Lowens MS, Totten PA, Golden MR, Simoni J. Suboptimal adherence to doxycycline and treatment outcomes among men with non-gonococcal urethritis: a prospective cohort study. Sex Transm Infect. 2014 Feb;90(1):3-7. doi: 10.1136/sextrans-2013-051174. Epub 2013 Oct 8.
- Derived from this study: PubMed 23223595Manhart LE, Gillespie CW, Lowens MS, Khosropour CM, Colombara DV, Golden MR, Hakhu NR, Thomas KK, Hughes JP, Jensen NL, Totten PA. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial. Clin Infect Dis. 2013 Apr;56(7):934-42. doi: 10.1093/cid/cis1022. Epub 2012 Dec 7.
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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.
Lisa E Manhart, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin and Doxycycline in people with Urethritis, run by University of Washington at 1 site 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 6 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Mar 2013). 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?
mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit (time frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)). The study lists 2 primary outcomes in all. 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 NCT00358462, which also lists 3 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 15 Aug 2018.