MalariaNCT04695886
Effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar
A study testing Community-delivered Integrated Malaria Elimination (CIME) intervention model in people with Malaria, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd.
Trial summary
In Myanmar, community health workers, known as malaria volunteers, have played a key role in reducing the malaria burden in the malaria control phase, providing essential malaria services in rural areas where the coverage of formal health services is limited. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Community-delivered Integrated Malaria Elimination (CIME) intervention model
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,440 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jul 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Villages in Ayeyarwaddy, Bago and Yangon Regions and Kayah State townships in Myanmar with National Malaria Control Program (NMCP) trained Integrated Community Malaria Volunteers (ICMVs).
Who cannot join
- Townships
- A township will be excluded from the study if:
- The township does not have an NMCP provided ICMV network
- The township has ongoing armed conflict
- The township does not have Vector-Borne Diseases Control (VBDC) staff or malaria focal person
- The location of the township is not geographically or politically feasible for staff from the State/Regional capital city to conduct regular supervision visits
Show all 14Show fewer
- Villages
- After selection of 8 townships (2 townships from each state/region), villages in the townships will be screened against the exclusion criteria. A village will be excluded from the study if:
- The village is too remote and unable to execute the CIME model completely,
- The village has a government public health facility,
- The village has no mobile network coverage
- The village is in the ongoing armed conflict zone , or
- The village has an ICMV program operated by any organizations other than NMCP
- The village has an Annual Parasite Index (API) >=5
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effectiveness and Cost-effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar: An Open Stepped-wedge Cluster-randomised Controlled Trial
In Myanmar, community health workers, known as malaria volunteers, have played a key role in reducing the malaria burden in the malaria control phase, providing essential malaria services in rural areas where the coverage of formal health services is limited. However, the community-delivered models that have worked well for malaria control may not work well for malaria elimination. In parallel with switching from interventions for malaria control to those for elimination, the motivation and social importance of malaria volunteers has declined along with the decline of the malaria burden. To sustain volunteer motivation, the social importance and effectiveness in the malaria elimination program, the Community-delivered Integrated Malaria Elimination model for Myanmar (CIME model) was developed based on global evidence and qualitative consultations with community members, leaders, volunteers and health stakeholders in Myanmar. This study will assess the level of effectiveness of the CIME model in increasing malaria testing by its application in an open cluster-randomised controlled stepped-wedge trial.
Read the detailed description
The CIME model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and Rapid Diagnostic Test (RDT)-negative fever. It will involve the recruitment and training of a volunteer to implement the CIME model in each village.
The primary outcome of the trial is blood examination rate as determined by number of RDTs for malaria performed per week per village. 140 villages in 8 townships across Ayeyarwaddy, Bago and Yangon Regions and Kayah State in Myanmar will be sampled at random with probability proportional to size. Study populations include villages with ICMVs who will be re-trained as CIME volunteers (intervention phase) and the community members in the service catchment areas of those volunteers. An open stepped-wedge cluster-randomised controlled trial, randomized at the volunteer level (i.e. the volunteer and the village / workplaces they service), will be conducted over 6-months to evaluate the effectiveness and cost-effectiveness of the CIME model intervention. The stepped-wedge design will comprises 24 weekly measurements of the number of malaria blood examinations performed by each village, with villages grouped into 10 blocks of 14 villages and transitioned from control to intervention phases at bi-weekly intervals following a universal two-week control period. Differences in the per weekly rate of blood examination (primary outcome), will be estimated across intervention and control phases using a generalised linear (e.g. Poisson or negative-binomial link functions) mixed modelling analytical approach with maximum likelihood estimation.
- Conditions
- Malaria
- Being tested
- Community-delivered Integrated Malaria Elimination (CIME) intervention model
- Keywords
- Community-delivered, Intervention, elimination, falciparum, vivax, routine testing, Stepped-wedge
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-delivered Integrated Malaria Elimination (CIME) intervention modelOther
Malaria: Malaria Diagnosis using RDT, treatment, referral and reporting; Prevention interventions (Behavioral Change Communication, net and repellent distribution); assisting in case and foci investigation and larval source management.
Dengue: Assisting in dengue prevention; Referral of cases. Tuberculosis (TB): Detection and referral of suspected cases; Contact tracing; Directly observed treatment, short-course (DOTS) providers; defaulter tracing; follow-up sputum examinations; assisting in TB health education talks and active case detection activities.
Childhood diarrhea: Prevention; Health education and Water, sanitation and hygiene (WASH) promotion; Diagnosis and dehydration assessment; Treatment and referral; Rehydration therapy using Oral Rehydration Solution (ORS) and oral Zinc tablet; assisted referral.
RDT-negative fever: Prevention and health education; Symptomatic treatment with antipyretics and immediate assisted referral.
| Study group | Role | What they receive |
|---|---|---|
| CIME intervention | Experimental | Community-delivered Integrated Malaria Elimination (CIME). The CIME intervention model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and RDT-negative fever. Receives: Other: Community-delivered Integrated Malaria Elimination (CIME) intervention model |
| ICMV standard of care | No intervention | Integrated Community Malaria Volunteer (ICMV) model - this is the current standard of care. This model involves malaria volunteers undertaking additional screening and referral services for a range of other diseases including: dengue, lymphatic filariasis, tuberculosis, HIV/AIDS and leprosy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood examination rate
Change in blood examination rate as determined by the number of rapid diagnostic tests (RDTs) for malaria performed per week per village
Measured: Assessed weekly, longitudinally over 6-months
Secondary outcomes (18)
Plasmodium spp. infection detected by RDT
Change in the number of Plasmodium spp. infections detected by RDT per week per village
Measured: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infections reported with 24 hours
Change in the number and percentage of Plasmodium spp. infections reported within 24 hours of RDT per village
Measured: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infection detected by PCR
Change in the number of Plasmodium spp. infections detected by polymerase chain reaction (PCR) (from RDT cassette) per week
Measured: Assessed weekly, longitudinally over 6-months.
Larval source management
Change in the number of larval sources managed by the volunteer per week
Measured: Assessed weekly, longitudinally over 6-months.
Dengue cases
Change in the number of suspected Dengue cases referred to the nearby clinic per week
Measured: Assessed weekly, longitudinally over 6-months.
Tuberculosis (TB) cases
Change in the number of suspected tuberculosis cases referred for diagnosis to national tuberculosis program per week
Measured: Assessed weekly, longitudinally over 6-months
TB DOTS
Number of TB patients monitored by volunteer for DOTS over the whole study period
Measured: 6-month
Diarrheal cases diagnosed, treated and referred
Change in the number of diarrheal cases diagnosed, treated with ORS and zinc tablets and referred per week
Measured: Assessed weekly, longitudinally over 6-months
RDT-negative fever cases
Change in the number of RDT-negative fever cases referred per week
Measured: Assessed weekly, longitudinally over 6-months
Malaria treatment according to national policy
Change in the proportion of patients with confirmed malaria who received first-line antimalarial treatment according to national policy
Measured: Assessed weekly, longitudinally over 6-months
Data accuracy and completeness in reporting of malaria cases
Change in the number of accurately reported and complete malaria case records according the national malaria case-based reporting format
Measured: Assessed weekly, longitudinally over 6-months
Malaria drug resistance-associated mutations
Change in the proportion of Kelch13 and other resistance mutations detected by PCR from RDT cassettes
Measured: Assessed weekly, longitudinally over 6-months
Seroprevalence of malaria-associated antibodies
Change in the seroprevalence of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Measured: Assessed weekly, longitudinally over 6-months
Levels of malaria-associated antibodies
Change in the levels of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Measured: Assessed weekly, longitudinally over 6-months
Acceptability of the CIME model by villagers
Acceptability of the CIME model by villagers assessed by an investigator-developed questionnaire including component constructs such as affective attitude, burden, perceived effectiveness and self-efficacy.
Measured: 6-month
Acceptability of the CIME model by CIME volunteers
Acceptability of the CIME model by CIME volunteers assessed by an investigator-developed questionnaire including component constructs such as affective attitude, burden, perceived effectiveness and self-efficacy.
Measured: 6-month
Acceptability of the CIME model by stakeholders
Acceptability of the CIME model by stakeholders assessed by focus group discussions.
Measured: 6-month
Cost-effectiveness of the CIME model
Cost-effectiveness of the CIME model compared to ICMV model (Cost per unit detection, treatment and notification of a malaria case)
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
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 MalariaStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized control trial (one-way crossover)
- Masking
- None (open label)
- Enrolment
- 6,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Program, Myanmar
- Responsible party
- Sponsor
- Investigators
- Freya Fowkes, DPhil, Principal investigator, Burnet InstituteWin Han Oo, PhD, Principal investigator, Burnet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695886
- Sponsor's protocol ID
- 241/20_CIME_Malaria
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available after publication from the data custodian(s) to applicants who provide a sound proposal to The Ethics Review Committee on Medical Research Involving Human Subjects, Department of Medical Research, Myanmar Ministry of Health and Sports (No. 5 Ziwaka Road, Dagon PO Yangon, Myanmar; (+95) 01 375447 extension 118; ercdmr2015@gmail.com) contingent of their approval.
Publications
Win Han Oo, Htike W, May Chan Oo, Pwint Phyu Phyu, Kyawt Mon Win, Nay Yi Yi Linn, Tun Min, Ei Phyu Htwe, Aung Khine Zaw, Kaung Myat Thu, Galau NH, Cutts JC, Simpson JA, Scott N, O'Flaherty K, Agius PA, Fowkes FJI. Effectiveness of an expanded role for community health workers on malaria blood examination rates in malaria elimination settings in Myanmar: an open stepped-wedge, cluster-randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Oct 17;31:100499. doi: 10.1016/j.lansea.2024.100499. eCollection 2024 Dec.
PubMed 39492851Oo WH, Thi A, Htike W, Agius PA, Cutts JC, Win KM, Yi Linn NY, Than WP, Hkawng GN, Thu KM, Oo MC, O'Flaherty K, Kearney E, Scott N, Phyu PP, Htet AT, Myint O, Lwin Yee L, Thant ZP, Mon A, Htike S, Hnin TP, Fowkes FJI. Evaluation of the effectiveness and cost effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) model in Myanmar: protocol for an open stepped-wedge cluster-randomised controlled trial. BMJ Open. 2021 Aug 13;11(8):e050400. doi: 10.1136/bmjopen-2021-050400.
PubMed 34389579
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Cost-effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar: An Open Stepped-wedge Cluster-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04695886
- Acronym / sponsor ID
- 241/20_CIME_Malaria
- Conditions
- Malaria
- Keywords
- Community-delivered, Intervention, elimination, falciparum, vivax, routine testing, Stepped-wedge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,440 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- National Malaria Control Program, Myanmar
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- 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.
In Myanmar, community health workers, known as malaria volunteers, have played a key role in reducing the malaria burden in the malaria control phase, providing essential malaria services in rural areas where the coverage of formal health services is limited. However, the community-delivered models that have worked well for malaria control may not work well for malaria elimination. In parallel with switching from interventions for malaria control to those for elimination, the motivation and social importance of malaria volunteers has declined along with the decline of the malaria burden. To sustain volunteer motivation, the social importance and effectiveness in the malaria elimination program, the Community-delivered Integrated Malaria Elimination model for Myanmar (CIME model) was developed based on global evidence and qualitative consultations with community members, leaders, volunteers and health stakeholders in Myanmar. This study will assess the level of effectiveness of the CIME model in increasing malaria testing by its application in an open cluster-randomised controlled stepped-wedge trial.
Detailed description
The CIME model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and Rapid Diagnostic Test (RDT)-negative fever. It will involve the recruitment and training of a volunteer to implement the CIME model in each village.
The primary outcome of the trial is blood examination rate as determined by number of RDTs for malaria performed per week per village. 140 villages in 8 townships across Ayeyarwaddy, Bago and Yangon Regions and Kayah State in Myanmar will be sampled at random with probability proportional to size. Study populations include villages with ICMVs who will be re-trained as CIME volunteers (intervention phase) and the community members in the service catchment areas of those volunteers. An open stepped-wedge cluster-randomised controlled trial, randomized at the volunteer level (i.e. the volunteer and the village / workplaces they service), will be conducted over 6-months to evaluate the effectiveness and cost-effectiveness of the CIME model intervention. The stepped-wedge design will comprises 24 weekly measurements of the number of malaria blood examinations performed by each village, with villages grouped into 10 blocks of 14 villages and transitioned from control to intervention phases at bi-weekly intervals following a universal two-week control period. Differences in the per weekly rate of blood examination (primary outcome), will be estimated across intervention and control phases using a generalised linear (e.g. Poisson or negative-binomial link functions) mixed modelling analytical approach with maximum likelihood estimation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized control trial (one-way crossover)
| Arm | Type | Receives |
|---|---|---|
| CIME intervention | Experimental | Other: Community-delivered Integrated Malaria Elimination (CIME) intervention modelCommunity-delivered Integrated Malaria Elimination (CIME). The CIME intervention model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and RDT-negative fever. |
| ICMV standard of care | No intervention | –Integrated Community Malaria Volunteer (ICMV) model - this is the current standard of care. This model involves malaria volunteers undertaking additional screening and referral services for a range of other diseases including: dengue, lymphatic filariasis, tuberculosis, HIV/AIDS and leprosy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Villages in Ayeyarwaddy, Bago and Yangon Regions and Kayah State townships in Myanmar with National Malaria Control Program (NMCP) trained Integrated Community Malaria Volunteers (ICMVs).
Key exclusion criteria (14 listed)
- Townships
- The township does not have an NMCP provided ICMV network
- The township has ongoing armed conflict
- The township does not have Vector-Borne Diseases Control (VBDC) staff or malaria focal person
- The location of the township is not geographically or politically feasible for staff from the State/Regional capital city to conduct regular supervision visits
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 |
|---|---|---|
| Community-delivered Integrated Malaria Elimination (CIME) intervention modelMalaria: Malaria Diagnosis using RDT, treatment, referral and reporting; Prevention interventions (Behavioral Change Communication, net and repellent distribution); assisting in case and foci investigation and larval source management. Dengue: Assisting in dengue prevention; Referral of cases. Tuberculosis (TB): Detection and referral of suspected cases; Contact tracing; Directly observed treatment, short-course (DOTS) providers; defaulter tracing; follow-up sputum examinations; assisting in TB health education talks and active case detection activities. Childhood diarrhea: Prevention; Health education and Water, sanitation and hygiene (WASH) promotion; Diagnosis and dehydration assessment; Treatment and referral; Rehydration therapy using Oral Rehydration Solution (ORS) and oral Zinc tablet; assisted referral. RDT-negative fever: Prevention and health education; Symptomatic treatment with antipyretics and immediate assisted referral. | Other | CIME intervention |
Primary outcome
Blood examination rate
Time frame: Assessed weekly, longitudinally over 6-months
Change in blood examination rate as determined by the number of rapid diagnostic tests (RDTs) for malaria performed per week per village
18 secondary outcomes
Plasmodium spp. infection detected by RDT
Time frame: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infections reported with 24 hours
Time frame: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infection detected by PCR
Time frame: Assessed weekly, longitudinally over 6-months.
Larval source management
Time frame: Assessed weekly, longitudinally over 6-months.
Dengue cases
Time frame: Assessed weekly, longitudinally over 6-months.
Tuberculosis (TB) cases
Time frame: Assessed weekly, longitudinally over 6-months
TB DOTS
Time frame: 6-month
Diarrheal cases diagnosed, treated and referred
Time frame: Assessed weekly, longitudinally over 6-months
RDT-negative fever cases
Time frame: Assessed weekly, longitudinally over 6-months
Malaria treatment according to national policy
Time frame: Assessed weekly, longitudinally over 6-months
Data accuracy and completeness in reporting of malaria cases
Time frame: Assessed weekly, longitudinally over 6-months
Malaria drug resistance-associated mutations
Time frame: Assessed weekly, longitudinally over 6-months
Seroprevalence of malaria-associated antibodies
Time frame: Assessed weekly, longitudinally over 6-months
Levels of malaria-associated antibodies
Time frame: Assessed weekly, longitudinally over 6-months
Acceptability of the CIME model by villagers
Time frame: 6-month
Acceptability of the CIME model by CIME volunteers
Time frame: 6-month
Acceptability of the CIME model by stakeholders
Time frame: 6-month
Cost-effectiveness of the CIME model
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 39492851Win Han Oo, Htike W, May Chan Oo, Pwint Phyu Phyu, Kyawt Mon Win, Nay Yi Yi Linn, Tun Min, Ei Phyu Htwe, Aung Khine Zaw, Kaung Myat Thu, Galau NH, Cutts JC, Simpson JA, Scott N, O'Flaherty K, Agius PA, Fowkes FJI. Effectiveness of an expanded role for community health workers on malaria blood examination rates in malaria elimination settings in Myanmar: an open stepped-wedge, cluster-randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Oct 17;31:100499. doi: 10.1016/j.lansea.2024.100499. eCollection 2024 Dec.
- Derived from this study: PubMed 34389579Oo WH, Thi A, Htike W, Agius PA, Cutts JC, Win KM, Yi Linn NY, Than WP, Hkawng GN, Thu KM, Oo MC, O'Flaherty K, Kearney E, Scott N, Phyu PP, Htet AT, Myint O, Lwin Yee L, Thant ZP, Mon A, Htike S, Hnin TP, Fowkes FJI. Evaluation of the effectiveness and cost effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) model in Myanmar: protocol for an open stepped-wedge cluster-randomised controlled trial. BMJ Open. 2021 Aug 13;11(8):e050400. doi: 10.1136/bmjopen-2021-050400.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available after publication from the data custodian(s) to applicants who provide a sound proposal to The Ethics Review Committee on Medical Research Involving Human Subjects, Department of Medical Research, Myanmar Ministry of Health and Sports (No. 5 Ziwaka Road, Dagon PO Yangon, Myanmar; (+95) 01 375447 extension 118; ercdmr2015@gmail.com) contingent of their approval.
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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.
Freya Fowkes, DPhil principal investigator
Burnet Institute
Win Han Oo, PhD principal investigator
Burnet Institute
Questions about this trial
What is this clinical trial studying?
A study testing Community-delivered Integrated Malaria Elimination (CIME) intervention model in people with Malaria, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd.
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 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Freya Fowkes, DPhil (+61385062310, freya.fowkes@burnet.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood examination rate (time frame: Assessed weekly, longitudinally over 6-months). 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 NCT04695886, 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 5 Jan 2021.