DiarrheaPhase 3ABCDNCT03130114
Antibiotics for Children With Severe Diarrhoea
A Phase 3 study testing Azithromycin in people with Diarrhea, run by World Health Organization at 7 sites in 7 countries.
Trial summary
Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. Read more about this study
- Who is it for?
- Ages 2 to 23 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,268 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 13 May 2017to 15 Jan 2020
- Phase
- Phase 3
- 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 2 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 - 23 months, presenting to a designated health care facility at a participating study site with
- Diarrhoea per caregiver perception and at least 3 loose or watery stools in the previous 24 hours,
- Diarrhoea for less than 14 days prior to screening and with at least one of the following criteria at presentation:
- Signs of some or severe dehydration as per WHO Pocket Book 2013
- Moderately wasted as defined by a mid-upper arm circumference (MUAC) less than 125 mm (but greater than or equal to 115 mm) or a weight-for-length z-score (WLZ) greater than -3 standard deviations (SD) and less than or equal to -2 SD after rehydration during stabilization period or
- Severely stunted (length-for-age z-score (LAZ) <-3 SD) and
- Parent or guardian (caregiver) willing to allow household visits on day 2 and day 3 and willing to return to facility on day 90 and
- Parent or guardian (caregiver) provides a consent for trial participation on behalf of the child, based on local standards
Who cannot join
- Dysentery (gross blood in stool reported by caregiver or observed by healthcare worker (HCW)),
- Suspected Vibrio cholerae infection (determined according to WHO guidelines or clinical suspicion),
- Previously or currently enrolled in the ABCD study,
- Concurrently enrolled in another interventional clinical trial,
- Sibling or other child in the household enrolled in the ABCD study and currently taking study medication,
- Signs of associated infections (pneumonia, severe febrile illness, meningitis, mastoiditis or acute ear infection) requiring antibiotic treatment,
Show all 11Show fewer
- Documented antibiotic use in the 14 days prior to screening (not including standard use of prophylactic antibiotics, i.e. co-trimoxazole use in human immunodeficiency virus (HIV) -exposed children),
- Documented use of metronidazole within the last 14-days,
- Known allergy or contraindication to azithromycin antibiotics,
- Severe acute malnutrition (SAM) defined as weigh-for-length Z-score (WLZ) less than -3 SD, or MUAC less than 115 mm, or edema of both feet, or
- Living too far from the enrolment health center to ensure adequate Directly Observed Therapy (DOT) on day 2 and day 3
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth.
The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.
- Conditions
- Diarrhea
- Being tested
- Azithromycin, Placebo
- Keywords
- Mortality, Infant, Antibiotics, Linear Growth
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 10 mg (0.35 ml) / kg of azithromycin syrup per day, for three days
PlaceboOther
Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 0.25 ml / kg of placebo drug syrup per day, for three days
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo mixture, 0.25 ml / kg / day Receives: Other: Placebo |
| Azithromycin | Experimental | Azithromycin mixture (40 mg / ml), 0.25 ml / kg / day Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Proportion of children dying per arm
Measured: 180 days from enrolment
Linear growth
Mean change in length-for-age Z-score per arm. The Z score will be arrived at from the WHO growth charts based on length in cms and age in months
Measured: 90 days from enrolment
Secondary outcomes (9)
Hospitalizations upto Day 90
Proportion of children with at least one hospitalization upto Day 90 per arm
Measured: 90 days
Hospitalization or deaths upto day 90
Proportion of children with at least one hospitalization or death upto day 90 per arm
Measured: 90 days
Early hospitalization or death (upto day 10)
Proportion of children with death or any hospitalization per arm (upto day 10)
Measured: 10 days
Change in weight for length Z score
Mean change in weight-for-length Z-score per arm. The Z score will be arrived at from the WHO growth charts based on weight in kg and length in cm for each child
Measured: 90 days
Change in weight for age Z score
Mean change in weight-for-age Z-score per arm. The Z score will be arrived at from the WHO growth charts based on weight in kg and age in months for each child
Measured: 90 days
Change in Mid upper arm circumference
Mean change in MUAC (mm) per arm
Measured: 90 days
Antimicrobial resistance in the community
Proportion of study participants per arm harbouring antibiotic resistant E. coli bacteria in their stools before any intervention
Measured: Baseline
Antimicrobial resistance among the study participants (sub-group)
Proportion of study participants per arm harbouring antibiotic resistant S. pneumoniae bacteria in the naso-pharynx or E. coli bacteria in their stools
Measured: At the end of intervention (90 days) and three months later (180 days)
Antimicrobial resistance among close household child contacts (sub-group)
Proportion of siblings or other close household contacts (6-59 months old) per arm harbouring antibiotic resistant S. pneumoniae bacteria in the nasopharynx or E. coli bacteria in their stools
Measured: At the end of intervention (90 days) and three months later (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start13 May 2017
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Center for Public Health Kinetics, Kenya Medical Research Institute, University of Washington, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Liverpool, Centre pour le developpement des vaccines, Mali, University of Maryland, College Park, Aga Khan University, Muhimbili University of Health and Allied Sciences, Boston Children's Hospital
- Responsible party
- Principal investigator, Ayesha De Costa, World Health Organization
- Investigators
- Rajiv Bahl, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130114
- Sponsor's protocol ID
- ERC.0002722
- Acronym
- ABCD
- Status last verified
- May 2020
- First submitted
- 23 Apr 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Principal investigators are currently discussing this between themselves and their research organizations. The plan is to make the data available as soon as possible.
Publications
Somji S, Ashorn P, Manji K, Ahmed T, Chisti M, Dhingra U, Sazawal S, Singa B, Walson JL, Pavlinac P, Bar-Zeev N, Houpt E, Dube Q, Kotloff K, Sow S, Yousafzai MT, Qamar F, Bahl R, De Costa A, Simon J, Sudfeld CR, Duggan CP; ABCD Study Group. Clinical and nutritional correlates of bacterial diarrhoea aetiology in young children: a secondary cross-sectional analysis of the ABCD trial. BMJ Paediatr Open. 2024 Apr 11;8(1):e002448. doi: 10.1136/bmjpo-2023-002448.
PubMed 38604769Pavlinac PB, Platts-Mills JA, Liu J, Atlas HE, Gratz J, Operario D, Rogawski McQuade ET, Ahmed D, Ahmed T, Alam T, Ashorn P, Badji H, Bahl R, Bar-Zeev N, Chisti MJ, Cornick J, Chauhan A, De Costa A, Deb S, Dhingra U, Dube Q, Duggan CP, Freyne B, Gumbi W, Hotwani A, Kabir M, Islam O, Kabir F, Kasumba I, Kibwana U, Kotloff KL, Khan SS, Maiden V, Manji K, Mehta A, Ndeketa L, Praharaj I, Qamar FN, Sazawal S, Simon J, Singa BO, Somji S, Sow SO, Tapia MD, Tigoi C, Toure A, Walson JL, Yousafzai MT, Houpt ER; AntiBiotics for Children with severe Diarrhea (ABCD) Study Group. Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics. J Infect Dis. 2024 Apr 12;229(4):988-998. doi: 10.1093/infdis/jiad252.
PubMed 37405406Antibiotics for Children With Diarrhea (ABCD) Study Group; Ahmed T, Chisti MJ, Rahman MW, Alam T, Ahmed D, Parvin I, Kabir MF, Sazawal S, Dhingra P, Dutta A, Deb S, Chouhan A, Sharma AK, Jaiswal VK, Dhingra U, Walson JL, Singa BO, Pavlinac PB, McGrath CJ, Nyabinda C, Deichsel EL, Anyango M, Kariuki KM, Rwigi D, Tornberg-Belanger SN, Kotloff KL, Sow SO, Tapia MD, Haidara FC, Mehta A, Coulibaly F, Badji H, Permala-Booth J, Tennant SM, Malle D, Bar-Zeev N, Dube Q, Freyne B, Cunliffe N, Ndeketa L, Witte D, Ndamala C, Cornick J, Qamar FN, Yousafzai MT, Qureshi S, Shakoor S, Thobani R, Hotwani A, Kabir F, Mohammed J, Manji K, Duggan CP, Kisenge R, Sudfeld CR, Kibwana U, Somji S, Bakari M, Msemwa C, Samma A, Bahl R, De Costa A, Simon J, Ashorn P. Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2136726. doi: 10.1001/jamanetworkopen.2021.36726.
PubMed 34913980ABCD study team. A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol. Trials. 2020 Jan 13;21(1):71. doi: 10.1186/s13063-019-3829-y.
PubMed 31931848
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics for Children With Severe Diarrhoea
- ClinicalTrials.gov ID
- NCT03130114
- Acronym / sponsor ID
- ABCD / ERC.0002722
- Conditions
- Diarrhea
- Keywords
- Mortality, Infant, Antibiotics, Linear Growth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,268 participants (actual)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Center for Public Health Kinetics, Kenya Medical Research Institute, University of Washington, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Liverpool, Centre pour le developpement des vaccines, Mali, University of Maryland, College Park, Aga Khan University, Muhimbili University of Health and Allied Sciences, Boston Children's Hospital
- Study start
- 13 May 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 26 Apr 2017 (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.
Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth.
The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.
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 |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboPlacebo mixture, 0.25 ml / kg / day |
| Azithromycin | Experimental | Drug: AzithromycinAzithromycin mixture (40 mg / ml), 0.25 ml / kg / day |
Who may qualify
- Ages
- 2 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 2 - 23 months, presenting to a designated health care facility at a participating study site with
- Diarrhoea per caregiver perception and at least 3 loose or watery stools in the previous 24 hours,
- Diarrhoea for less than 14 days prior to screening and with at least one of the following criteria at presentation:
- Parent or guardian (caregiver) willing to allow household visits on day 2 and day 3 and willing to return to facility on day 90 and
- Parent or guardian (caregiver) provides a consent for trial participation on behalf of the child, based on local standards
Key exclusion criteria (11 listed)
- Dysentery (gross blood in stool reported by caregiver or observed by healthcare worker (HCW)),
- Suspected Vibrio cholerae infection (determined according to WHO guidelines or clinical suspicion),
- Previously or currently enrolled in the ABCD study,
- Concurrently enrolled in another interventional clinical trial,
- Sibling or other child in the household enrolled in the ABCD study and currently taking study medication,
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 |
|---|---|---|
| AzithromycinParticipants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 10 mg (0.35 ml) / kg of azithromycin syrup per day, for three days | Drug | Azithromycin |
| PlaceboParticipants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 0.25 ml / kg of placebo drug syrup per day, for three days | Other | Control |
Primary outcome
Mortality
Time frame: 180 days from enrolment
Proportion of children dying per arm
Linear growth
Time frame: 90 days from enrolment
Mean change in length-for-age Z-score per arm. The Z score will be arrived at from the WHO growth charts based on length in cms and age in months
9 secondary outcomes
Hospitalizations upto Day 90
Time frame: 90 days
Hospitalization or deaths upto day 90
Time frame: 90 days
Early hospitalization or death (upto day 10)
Time frame: 10 days
Change in weight for length Z score
Time frame: 90 days
Change in weight for age Z score
Time frame: 90 days
Change in Mid upper arm circumference
Time frame: 90 days
Antimicrobial resistance in the community
Time frame: Baseline
Antimicrobial resistance among the study participants (sub-group)
Time frame: At the end of intervention (90 days) and three months later (180 days)
Antimicrobial resistance among close household child contacts (sub-group)
Time frame: At the end of intervention (90 days) and three months later (180 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 38604769Somji S, Ashorn P, Manji K, Ahmed T, Chisti M, Dhingra U, Sazawal S, Singa B, Walson JL, Pavlinac P, Bar-Zeev N, Houpt E, Dube Q, Kotloff K, Sow S, Yousafzai MT, Qamar F, Bahl R, De Costa A, Simon J, Sudfeld CR, Duggan CP; ABCD Study Group. Clinical and nutritional correlates of bacterial diarrhoea aetiology in young children: a secondary cross-sectional analysis of the ABCD trial. BMJ Paediatr Open. 2024 Apr 11;8(1):e002448. doi: 10.1136/bmjpo-2023-002448.
- Derived from this study: PubMed 37405406Pavlinac PB, Platts-Mills JA, Liu J, Atlas HE, Gratz J, Operario D, Rogawski McQuade ET, Ahmed D, Ahmed T, Alam T, Ashorn P, Badji H, Bahl R, Bar-Zeev N, Chisti MJ, Cornick J, Chauhan A, De Costa A, Deb S, Dhingra U, Dube Q, Duggan CP, Freyne B, Gumbi W, Hotwani A, Kabir M, Islam O, Kabir F, Kasumba I, Kibwana U, Kotloff KL, Khan SS, Maiden V, Manji K, Mehta A, Ndeketa L, Praharaj I, Qamar FN, Sazawal S, Simon J, Singa BO, Somji S, Sow SO, Tapia MD, Tigoi C, Toure A, Walson JL, Yousafzai MT, Houpt ER; AntiBiotics for Children with severe Diarrhea (ABCD) Study Group. Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics. J Infect Dis. 2024 Apr 12;229(4):988-998. doi: 10.1093/infdis/jiad252.
- Derived from this study: PubMed 34913980Antibiotics for Children With Diarrhea (ABCD) Study Group; Ahmed T, Chisti MJ, Rahman MW, Alam T, Ahmed D, Parvin I, Kabir MF, Sazawal S, Dhingra P, Dutta A, Deb S, Chouhan A, Sharma AK, Jaiswal VK, Dhingra U, Walson JL, Singa BO, Pavlinac PB, McGrath CJ, Nyabinda C, Deichsel EL, Anyango M, Kariuki KM, Rwigi D, Tornberg-Belanger SN, Kotloff KL, Sow SO, Tapia MD, Haidara FC, Mehta A, Coulibaly F, Badji H, Permala-Booth J, Tennant SM, Malle D, Bar-Zeev N, Dube Q, Freyne B, Cunliffe N, Ndeketa L, Witte D, Ndamala C, Cornick J, Qamar FN, Yousafzai MT, Qureshi S, Shakoor S, Thobani R, Hotwani A, Kabir F, Mohammed J, Manji K, Duggan CP, Kisenge R, Sudfeld CR, Kibwana U, Somji S, Bakari M, Msemwa C, Samma A, Bahl R, De Costa A, Simon J, Ashorn P. Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2136726. doi: 10.1001/jamanetworkopen.2021.36726.
- Derived from this study: PubMed 31931848ABCD study team. A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol. Trials. 2020 Jan 13;21(1):71. doi: 10.1186/s13063-019-3829-y.
- Individual participant dataSharing planned: Undecided. The Principal investigators are currently discussing this between themselves and their research organizations. The plan is to make the data available as soon as possible.
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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.
Rajiv Bahl study director
World Health Organization
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Diarrhea, run by World Health Organization at 7 sites in 7 countries.
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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bangladesh, India, Kenya, Malawi, Mali and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 180 days from enrolment). 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 NCT03130114, which also lists 4 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 19 May 2020; AzTrials last refreshed its copy on 31 Oct 2026.