Malaria,FalciparumPhase 4EPiTOMISENCT03178643
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
A Phase 4 study testing Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) and Dihydroartemisinin-Piperaquine (DP) in people with Malaria,Falciparum, run by Duke University at 1 site in Kenya.
Trial summary
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) and Dihydroartemisinin-Piperaquine (DP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteKenya
- Study dates
- 23 Jan 2018to 16 Dec 2020
- Phase
- Phase 4
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age greater than 12 months and less than 10 years at enrollment;
- Current attendance at or willingness to attend the study SCA clinic at HBCH;
- Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
- Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
- No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
- Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed;
- Ability and willingness of parent or legally authorized representative (LAR) to give informed consent;
- Assent of child in those > 7 years.
Who cannot join
- Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
- Temperature of ≥ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
- Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
- Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
- Currently participating in another clinical research study, or having participated in one in the prior 30 days;
- Living in the same household as a previously-enrolled study participant;
- Chronic use of medications known to prolong the QT interval in children (see Appendix J);
- Fridericia's corrected QT interval (QTcF) interval > 450msec.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Homa Bay County Referral Hospital
Homa Bay Town, Homa Bay County, 40300
About this study
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Read the detailed description
Purpose of the study:
Primary Objective: To compare the efficacy of daily proguanil with monthly sulfadoxine/pyrimethanine-amodiaquine (SP-AQ) and with monthly dihydroartemisinin-piperaquine (DP) on the incidence of falciparum malaria in children with SCA.
Secondary Objective: To compare the efficacy of these malaria chemoprevention strategies on the incidence of major complications of SCA.
Background \& significance
Over 240,000 children with sickle cell anemia (SCA) are born in Africa annually. This number will increase to over 350,000 annual births of children with SCA by the year 2050. Without sophisticated medical care, SCA patients in African settings die at young ages: in a Western Kenya cohort of newborns, 25% of SCA children died before their 3rd birthday. Caring effectively for these children will be a major challenge for developing medical and public health systems in Africa including Kenya, and modeling studies suggest that the adequate provision of effective preventive care can substantially reduce the mortality of these children. Preventive care for SCA children must be evidence-based and tailored to the unique epidemiology of comorbidities in African settings.
Children under 5 years of age in sub-Saharan Africa also suffer the majority of the annual 350 million infections and 500,000 deaths globally. Reducing this burden is a global public health priority, particularly in areas of high transmission like Western Kenya. In the absence of an effective vaccine, global malaria control requires effective treatments and a suite of preventive measures that act upon the parasite, environment, and host. Among these preventive strategies is the administration of prophylactic antimalarials to high risk groups, including pregnant women, infants, and children exposed to seasonal malaria transmission. In these high-risk groups malaria morbidity is substantially reduced by routine periodic intake of effective antimalarials.
Children with SCA are at high risk of life-threatening malaria. In East Africa children with SCA admitted to the hospital with malaria parasites were more likely to die than those without parasites. Malaria is also a precipitant of sickle-cell pain crises, by unclear mechanisms. It remains unclear how SCA influences the overall risk of malaria, because most studies have been hospital based and therefore unsuited to capture mild episodes. The twin observations that malaria is more severe in SCA children and precipitates painful crises in these children indicate that the prevention of P. falciparum infections is critical to prolong the survival of SCA children in malaria-endemic areas.
Design \& procedures - This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
- Conditions
- Malaria,Falciparum
- Being tested
- Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ), Dihydroartemisinin-Piperaquine (DP)
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proguanil Oral TabletDrug
Dosing of daily proguanil will be approximately 3mg/kg/day,
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ)Drug
Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
Dihydroartemisinin-Piperaquine (DP)Drug
- The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
| Study group | Role | What they receive |
|---|---|---|
| Proguanil Oral Tablet | Active comparator | Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis Receives: Drug: Proguanil Oral Tablet |
| Sulfadoxine/Pyrimethanine-Amodiaquine | Active comparator | Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis. Receives: Drug: Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) |
| Dihydroartemisinin-Piperaquine (DP) | Active comparator | DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis. Receives: Drug: Dihydroartemisinin-Piperaquine (DP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinical Malaria Per Patient Year
The primary endpoint is the cumulative incidence of clinical malaria expressed as episodes per person-year at risk. Time at risk will begin when study participants are randomized and receive study drug (i.e. begin chemoprevention) and end when participants reach the end of the observation period.
Measured: 12 months
Secondary outcomes (14)
Number of Participants With Severe Anemia
E.g., hemoglobin <5.5 g/dL
Measured: 12 months
Number of Participants With Severe Malaria
Positive rapid diagnostic test (RDT).
Measured: 12 months
Number of Participants With Hospitalization for Malaria
Patient admitted to hospital for malaria with confirmed positive RDT.
Measured: 12 months
Number of Participants With Light Microscopy (LM)-Positive Malaria
LM-positive malaria defined as the reported presence of P. falciparum parasites detected by LM irrespective of RDT or other detection results.
Measured: 12 months
Number of Participants With Unconfirmed Malaria
Defined as the receipt of antimalarials for suspected malaria episodes that were not confirmed by any objective diagnostic test.
Measured: 12 months
Number of Participants With Fatal Malaria
Defined as death during hospitalization for malaria with positive RDT.
Measured: 12 months
Number of Participants With Asymptomatic Parasitization
Defined as the presence of parasites during routine follow-up visits as detected by PCR in patients without fever or a history of recent fever.
Measured: 12 months
Number of Participants With Painful Events
Pain lasting two hours or more without obvious cause.
Measured: 12 months
Number of Participants With Dactylitis
Pain or tenderness with or without swelling of the hands or feet.
Measured: 12 months
Number of Participants With Transfusions
Receipt of RBCs (red blood cells) from any caregiver for any indication.
Measured: 12 months
Number of Participants With Acute Chest Syndrome
Defined as a new pulmonary infiltrate and at least 3 of the following findings: chest pain, temperature elevation > 38.5°C, tachypnea, wheezing, or cough.
Measured: 12 months
Number of Participants With All-cause Hospitalization
Hospitalization at HBCH or any other inpatient facility with any admitting diagnosis.
Measured: 12 months
All-cause Deaths
Death by any cause.
Measured: 12 months
Molecular Markers of Malaria Parasite Drug Resistance
presence of SNPs in parasite genes that confer resistance to the study drugs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start23 Jan 2018
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
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 Malaria,FalciparumStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178643
- Sponsor's protocol ID
- Pro00077428
- Other IDs
- R01HL134211
- Acronym
- EPiTOMISE
- Status last verified
- Apr 2024
- First submitted
- 1 Jun 2017
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taylor SM, Korwa S, Wu A, Green CL, Freedman B, Clapp S, Kirui JK, O'Meara WP, Njuguna FM. Monthly sulfadoxine/pyrimethamine-amodiaquine or dihydroartemisinin-piperaquine as malaria chemoprevention in young Kenyan children with sickle cell anemia: A randomized controlled trial. PLoS Med. 2022 Oct 10;19(10):e1004104. doi: 10.1371/journal.pmed.1004104. eCollection 2022 Oct.
PubMed 36215323
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
- ClinicalTrials.gov ID
- NCT03178643
- Acronym / sponsor ID
- EPiTOMISE / Pro00077428
- Conditions
- Malaria,Falciparum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Detailed description
Purpose of the study:
Primary Objective: To compare the efficacy of daily proguanil with monthly sulfadoxine/pyrimethanine-amodiaquine (SP-AQ) and with monthly dihydroartemisinin-piperaquine (DP) on the incidence of falciparum malaria in children with SCA.
Secondary Objective: To compare the efficacy of these malaria chemoprevention strategies on the incidence of major complications of SCA.
Background \& significance
Over 240,000 children with sickle cell anemia (SCA) are born in Africa annually. This number will increase to over 350,000 annual births of children with SCA by the year 2050. Without sophisticated medical care, SCA patients in African settings die at young ages: in a Western Kenya cohort of newborns, 25% of SCA children died before their 3rd birthday. Caring effectively for these children will be a major challenge for developing medical and public health systems in Africa including Kenya, and modeling studies suggest that the adequate provision of effective preventive care can substantially reduce the mortality of these children. Preventive care for SCA children must be evidence-based and tailored to the unique epidemiology of comorbidities in African settings.
Children under 5 years of age in sub-Saharan Africa also suffer the majority of the annual 350 million infections and 500,000 deaths globally. Reducing this burden is a global public health priority, particularly in areas of high transmission like Western Kenya. In the absence of an effective vaccine, global malaria control requires effective treatments and a suite of preventive measures that act upon the parasite, environment, and host. Among these preventive strategies is the administration of prophylactic antimalarials to high risk groups, including pregnant women, infants, and children exposed to seasonal malaria transmission. In these high-risk groups malaria morbidity is substantially reduced by routine periodic intake of effective antimalarials.
Children with SCA are at high risk of life-threatening malaria. In East Africa children with SCA admitted to the hospital with malaria parasites were more likely to die than those without parasites. Malaria is also a precipitant of sickle-cell pain crises, by unclear mechanisms. It remains unclear how SCA influences the overall risk of malaria, because most studies have been hospital based and therefore unsuited to capture mild episodes. The twin observations that malaria is more severe in SCA children and precipitates painful crises in these children indicate that the prevention of P. falciparum infections is critical to prolong the survival of SCA children in malaria-endemic areas.
Design \& procedures - This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proguanil Oral Tablet | Active comparator | Drug: Proguanil Oral TabletProguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis |
| Sulfadoxine/Pyrimethanine-Amodiaquine | Active comparator | Drug: Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ)Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis. |
| Dihydroartemisinin-Piperaquine (DP) | Active comparator | Drug: Dihydroartemisinin-Piperaquine (DP)DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age greater than 12 months and less than 10 years at enrollment;
- Current attendance at or willingness to attend the study SCA clinic at HBCH;
- Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
- Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
- No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
Key exclusion criteria (8 listed)
- Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
- Temperature of ≥ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
- Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
- Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
- Currently participating in another clinical research study, or having participated in one in the prior 30 days;
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 |
|---|---|---|
| Proguanil Oral TabletDosing of daily proguanil will be approximately 3mg/kg/day, | Drug | Proguanil Oral Tablet |
| Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ)Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day | Drug | Sulfadoxine/Pyrimethanine-Amodiaquine |
| Dihydroartemisinin-Piperaquine (DP)3) The weight-based dosing of tablets of 40/320mg of DP is described below: Weight (kg) No. of 40/320mg tabs DP daily for 3 days ≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½ | Drug | Dihydroartemisinin-Piperaquine (DP) |
Primary outcome
Incidence of Clinical Malaria Per Patient Year
Time frame: 12 months
The primary endpoint is the cumulative incidence of clinical malaria expressed as episodes per person-year at risk. Time at risk will begin when study participants are randomized and receive study drug (i.e. begin chemoprevention) and end when participants reach the end of the observation period.
14 secondary outcomes
Number of Participants With Severe Anemia
Time frame: 12 months
Number of Participants With Severe Malaria
Time frame: 12 months
Number of Participants With Hospitalization for Malaria
Time frame: 12 months
Number of Participants With Light Microscopy (LM)-Positive Malaria
Time frame: 12 months
Number of Participants With Unconfirmed Malaria
Time frame: 12 months
Number of Participants With Fatal Malaria
Time frame: 12 months
Number of Participants With Asymptomatic Parasitization
Time frame: 12 months
Number of Participants With Painful Events
Time frame: 12 months
Number of Participants With Dactylitis
Time frame: 12 months
Number of Participants With Transfusions
Time frame: 12 months
Number of Participants With Acute Chest Syndrome
Time frame: 12 months
Number of Participants With All-cause Hospitalization
Time frame: 12 months
All-cause Deaths
Time frame: 12 months
Molecular Markers of Malaria Parasite Drug Resistance
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36215323Taylor SM, Korwa S, Wu A, Green CL, Freedman B, Clapp S, Kirui JK, O'Meara WP, Njuguna FM. Monthly sulfadoxine/pyrimethamine-amodiaquine or dihydroartemisinin-piperaquine as malaria chemoprevention in young Kenyan children with sickle cell anemia: A randomized controlled trial. PLoS Med. 2022 Oct 10;19(10):e1004104. doi: 10.1371/journal.pmed.1004104. eCollection 2022 Oct.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) and Dihydroartemisinin-Piperaquine (DP) in people with Malaria,Falciparum, run by Duke University at 1 site in Kenya.
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 8 inclusion and 8 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 23 Apr 2024. 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 Kenya. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Mar 2024). 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?
Incidence of Clinical Malaria Per Patient Year (time frame: 12 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 NCT03178643, 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 23 Apr 2024.