Childhood MortalityPhase 4NAITRENCT03682653
Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
A Phase 4 study testing Azithromycin in people with Childhood Mortality, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial summary
Although under-5 mortality rates are declining globally, neonatal mortality remains persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania, and Malawi. Read more about this study
- Who is it for?
- Ages 8 to 27 daysHealthy volunteers can take part
- Conditions the study is for
- Childhood Mortality
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21,832 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 11 Apr 2019to 31 Dec 2022
- 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 8 to 27 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Within 4 hours of a facility that can provide services for pyloromyotomy (Ouagadougou or Bobo Dioulasso)
- Accessible during the rainy season
- Ultrasound machine available OR a facility in which an ultrasound machine could be placed is within 1 hour
- Weight over 2500 g
- Able to feed orally
- Family intends to stay in study area for at least 6 months
Show all 10Show fewer
- Appropriate consent from at least one caregiver
- No known allergy to azalides
- Not living within one of the communities included in the community study(CHAT/CHATON)
- No hepatic failure manifested by neonatal jaundice
Who cannot join
- Refusal of village chief
- Individuals:
- Weight <2500 g
- Unable to feed orally
- Family planning to move
- Mother/caregiver not willing to participate
Show all 9Show fewer
- Allergic to azalides
- Living in one of the communities included in the community study (CHAT/CHATON)
- Hepatic failure manifested by neonatal jaundice
Trial locations and contacts
1 site in 1 country.
About this study
Although under-5 mortality rates are declining globally, neonatal mortality remains persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania, and Malawi. This study did not evaluate the effect of azithromycin administered during the neonatal period. Observational evidence from high income countries has suggested that macrolides, including erythromycin and azithromycin, may be associated with increased risk of development of infantile hypertrophic pyloric stenosis (IHPS). However, these studies are limited by confounding by indication, as infants only receive antibiotics when they are ill.
The investigators proposed an individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period. The long-term goal is generate evidence that can be used by neonatal and child survival programs related to the use of azithromycin in the youngest children who have the highest risk of mortality. The investigators hypothesize that a single dose of azithromycin administered in the neonatal period will lead to significantly reduced risk of mortality and that this dose will be safe.
Read more
Objectives
- Establish the efficacy of a single dose of azithromycin administered during the neonatal period compared to placebo in infants 8 to 27 days of life for reduction in all-cause mortality.
- Establish the safety of a single dose of azithromycin administered during the neonatal period.
This study will be conducted in several regions of Burkina Faso, including peri-urban areas of Ouagadougou and Nouna town, and rural areas that are within 4 hours' drive of a pediatric facility with capacity for performing pyloromyotomy
Read the detailed description
Child mortality in West Africa is among the highest in the world. Although child health and mortality are improving worldwide, children in the Sahel and sub-Sahel regions of West Africa have the greatest risks of mortality. Burkina Faso's current under-5 mortality rate is estimated 110 per 1,000 live births. Similar to other countries in the region, the major causes of child mortality in Burkina Faso are malaria, respiratory tract infection, and diarrhea. Malnutrition acts as a major underlying contributor to mortality. Neonatal mortality remains persistently high, with approximately 1/5th of neonatal mortality due to pneumonia, meningitis, and sepsis. Interventions that address these underlying causes may be particularly efficacious for reducing mortality.
Younger children at are at a higher risk of mortality. Approximately 2/3rd of under-5 deaths occur during the first year of life. In general, the child mortality rate decreases as age increases. While some improvement has been observed, neonatal mortality is declining at a slower rate than post-neonatal childhood mortality. Many child health interventions are designed specifically for children over 6 months of age, such as vitamin A supplementation, seasonal malaria chemoprevention, and lipid-based nutritional supplementation. Identification of strategies that are safe and effective for the youngest children will be required to address persistently high rates of neonatal and infant mortality.
The MORDOR I study demonstrated a significant reduction in all-cause child mortality following biannual mass azithromycin distribution. Across three diverse geographic locations in sub-Saharan Africa (Malawi, Niger, and Tanzania), biannual mass azithromycin distribution over a two-year period led to a 14% decrease in all-cause child mortality. In Niger, 1 in 5-6 deaths were averted. These results are qualitatively similar to those of a previous study of mass azithromycin distribution for trachoma control in Ethiopia, which found reduced odds of all-cause mortality in children in communities receiving mass azithromycin compared to control communities.
In MORDOR I, the strongest effect of azithromycin was in the youngest cohort of children. Across all three countries, the strongest effect of azithromycin was consistently in children 1-5 months of age, with an approximately 25% reduction in all-cause mortality. However, MORDOR I was not optimized to target the youngest age groups. Although children as young as 1 month were eligible, biannual distributions might not reach some children until 7 months of age. On average, children were first treated at 4 months. Given that there may be a substantial benefit to treating children at younger ages, azithromycin strategies that are designed to target younger age groups may be even more beneficial for reducing child mortality.
Here, the investigators propose a randomized controlled trial designed to evaluate the efficacy of a dose of azithromycin administered during the neonatal period for prevention of mortality within in the first 6 months of life. The investigators propose to randomize births in several geographic regions of Burkina Faso to a single dose of azithromycin or placebo between day 8 and 27 of life. This study is designed to provide evidence of the efficacy of azithromycin treatment for the youngest children.
- Conditions
- Childhood Mortality
- Being tested
- Azithromycin, Placebo
- Keywords
- childhood mortality, neonates, azithromycin, mass drug administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
PlaceboDrug
a single dose of Placebo will be administered to infants between their 8-27th days of life
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | a single dose of Azithromycin will be administered to infants between their 8-27th days of life Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | a single dose of placebo will be administered to infants between their 8-27th days of life Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Mortality - All Cause
The primary outcome of the study was all-cause mortality rate in infants at 6 months of age.
Measured: 6 months
Secondary outcomes (7)
12 Month Mortality - All Cause
All-cause Mortality Rate in infants at 12 months of age
Measured: 12 months
Vital Status
Caregivers will be asked if the child is dead or alive at 365 days of life
Measured: 12 months
Change in Weight Over Time
Weight gain from baseline to day 180
Measured: 6 months
Change in Length Over Time
Change in length from baseline to day 180
Measured: 6 months
Proportion of Infants Developing Infantile Hypertrophic Pyloric Stenosis
Proportion of infants developing infantile hypertrophic pyloric stenosis between 2 to 8 weeks after treatment
Measured: 8 weeks
Adverse Events
Caregivers will be asked if their child experienced any symptoms for pyloric stenosis since the last visit.
Measured: 12 months
Neonatal Mortality
Mortality prior to 28 days of life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start11 Apr 2019
- Primary completion1 May 2022
- Study completion31 Dec 2022
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 (5)Papers the sponsor has linked to this study.
- Other trials for Childhood MortalityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Catherine E Oldenburg, PhD, Principal investigator, University of California, San FranciscoTom M Lietman, MD, Principal investigator, University of California, San FranciscoAli Sie, MD, PhD, Principal investigator, Centre de Recherche en Sante de Nouna, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682653
- Sponsor's protocol ID
- OPP1187628-B
- Acronym
- NAITRE
- Status last verified
- Jun 2023
- First submitted
- 19 Sep 2018
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available as per the Bill and Melinda Gates open access policy. Individual participant data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines.
Publications
Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Brogdon J, Lebas E, Nyatigo F, Medvedev MM, Arnold BF, Lietman TM, Oldenburg CE; NAITRE Study Team. Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. PLOS Glob Public Health. 2023 May 15;3(5):e0001009. doi: 10.1371/journal.pgph.0001009. eCollection 2023.
PubMed 37186577Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Ouattara M, Lebas E, Brogdon J, Nyatigo F, O'Brien KS, Porco TC, Barnighausen T, Arnold BF, Lietman TM, Oldenburg CE; NAITRE Study Team. Neonatal Azithromycin Administration and Growth during Infancy: A Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Mar 27;108(5):1063-1070. doi: 10.4269/ajtmh.22-0763. Print 2023 May 3.
PubMed 36972694Oldenburg CE, Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Koueta F, Lebas E, Brogdon J, Nyatigo F, Doan T, Porco TC, Arnold BF, Lietman TM; NAITRE Study Team. Neonatal azithromycin administration for prevention of infant mortality. NEJM Evid. 2022 Apr;1(4):EVIDoa2100054. doi: 10.1056/EVIDoa2100054. Epub 2022 Mar 17.
PubMed 35692260Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Lebas E, Brogdon J, Nyatigo F, Arnold BF, Lietman TM, Oldenburg CE. Antenatal care attendance and risk of low birthweight in Burkina Faso: a cross-sectional study. BMC Pregnancy Childbirth. 2021 Dec 13;21(1):825. doi: 10.1186/s12884-021-04310-6.
PubMed 34903190Sie A, Bountogo M, Nebie E, Ouattara M, Coulibaly B, Bagagnan C, Zabre P, Lebas E, Brogdon J, Godwin WW, Lin Y, Porco T, Doan T, Lietman TM, Oldenburg CE; NAITRE Study Group. Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 4;9(9):e031162. doi: 10.1136/bmjopen-2019-031162.
PubMed 31488494
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
- ClinicalTrials.gov ID
- NCT03682653
- Acronym / sponsor ID
- NAITRE / OPP1187628-B
- Conditions
- Childhood Mortality
- Keywords
- childhood mortality, neonates, azithromycin, mass drug administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,832 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Bill and Melinda Gates Foundation
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although under-5 mortality rates are declining globally, neonatal mortality remains persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania, and Malawi. This study did not evaluate the effect of azithromycin administered during the neonatal period. Observational evidence from high income countries has suggested that macrolides, including erythromycin and azithromycin, may be associated with increased risk of development of infantile hypertrophic pyloric stenosis (IHPS). However, these studies are limited by confounding by indication, as infants only receive antibiotics when they are ill.
The investigators proposed an individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period. The long-term goal is generate evidence that can be used by neonatal and child survival programs related to the use of azithromycin in the youngest children who have the highest risk of mortality. The investigators hypothesize that a single dose of azithromycin administered in the neonatal period will lead to significantly reduced risk of mortality and that this dose will be safe.
Objectives
- Establish the efficacy of a single dose of azithromycin administered during the neonatal period compared to placebo in infants 8 to 27 days of life for reduction in all-cause mortality.
- Establish the safety of a single dose of azithromycin administered during the neonatal period.
This study will be conducted in several regions of Burkina Faso, including peri-urban areas of Ouagadougou and Nouna town, and rural areas that are within 4 hours' drive of a pediatric facility with capacity for performing pyloromyotomy
Detailed description
Child mortality in West Africa is among the highest in the world. Although child health and mortality are improving worldwide, children in the Sahel and sub-Sahel regions of West Africa have the greatest risks of mortality. Burkina Faso's current under-5 mortality rate is estimated 110 per 1,000 live births. Similar to other countries in the region, the major causes of child mortality in Burkina Faso are malaria, respiratory tract infection, and diarrhea. Malnutrition acts as a major underlying contributor to mortality. Neonatal mortality remains persistently high, with approximately 1/5th of neonatal mortality due to pneumonia, meningitis, and sepsis. Interventions that address these underlying causes may be particularly efficacious for reducing mortality.
Younger children at are at a higher risk of mortality. Approximately 2/3rd of under-5 deaths occur during the first year of life. In general, the child mortality rate decreases as age increases. While some improvement has been observed, neonatal mortality is declining at a slower rate than post-neonatal childhood mortality. Many child health interventions are designed specifically for children over 6 months of age, such as vitamin A supplementation, seasonal malaria chemoprevention, and lipid-based nutritional supplementation. Identification of strategies that are safe and effective for the youngest children will be required to address persistently high rates of neonatal and infant mortality.
The MORDOR I study demonstrated a significant reduction in all-cause child mortality following biannual mass azithromycin distribution. Across three diverse geographic locations in sub-Saharan Africa (Malawi, Niger, and Tanzania), biannual mass azithromycin distribution over a two-year period led to a 14% decrease in all-cause child mortality. In Niger, 1 in 5-6 deaths were averted. These results are qualitatively similar to those of a previous study of mass azithromycin distribution for trachoma control in Ethiopia, which found reduced odds of all-cause mortality in children in communities receiving mass azithromycin compared to control communities.
In MORDOR I, the strongest effect of azithromycin was in the youngest cohort of children. Across all three countries, the strongest effect of azithromycin was consistently in children 1-5 months of age, with an approximately 25% reduction in all-cause mortality. However, MORDOR I was not optimized to target the youngest age groups. Although children as young as 1 month were eligible, biannual distributions might not reach some children until 7 months of age. On average, children were first treated at 4 months. Given that there may be a substantial benefit to treating children at younger ages, azithromycin strategies that are designed to target younger age groups may be even more beneficial for reducing child mortality.
Here, the investigators propose a randomized controlled trial designed to evaluate the efficacy of a dose of azithromycin administered during the neonatal period for prevention of mortality within in the first 6 months of life. The investigators propose to randomize births in several geographic regions of Burkina Faso to a single dose of azithromycin or placebo between day 8 and 27 of life. This study is designed to provide evidence of the efficacy of azithromycin treatment for the youngest children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: Azithromycina single dose of Azithromycin will be administered to infants between their 8-27th days of life |
| Placebo | Placebo comparator | Drug: Placeboa single dose of placebo will be administered to infants between their 8-27th days of life |
Who may qualify
- Ages
- 8 to 27 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Within 4 hours of a facility that can provide services for pyloromyotomy (Ouagadougou or Bobo Dioulasso)
- Accessible during the rainy season
- Ultrasound machine available OR a facility in which an ultrasound machine could be placed is within 1 hour
- Weight over 2500 g
- Able to feed orally
Key exclusion criteria (9 listed)
- Refusal of village chief
- Weight <2500 g
- Unable to feed orally
- Family planning to move
- Mother/caregiver not willing to participate
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 |
|---|---|---|
| Azithromycina single dose of Azithromycin will be administered to infants between their 8-27th days of life | Drug | Azithromycin |
| Placeboa single dose of Placebo will be administered to infants between their 8-27th days of life | Drug | Placebo |
Primary outcome
6 Month Mortality - All Cause
Time frame: 6 months
The primary outcome of the study was all-cause mortality rate in infants at 6 months of age.
7 secondary outcomes
12 Month Mortality - All Cause
Time frame: 12 months
Vital Status
Time frame: 12 months
Change in Weight Over Time
Time frame: 6 months
Change in Length Over Time
Time frame: 6 months
Proportion of Infants Developing Infantile Hypertrophic Pyloric Stenosis
Time frame: 8 weeks
Adverse Events
Time frame: 12 months
Neonatal Mortality
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37186577Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Brogdon J, Lebas E, Nyatigo F, Medvedev MM, Arnold BF, Lietman TM, Oldenburg CE; NAITRE Study Team. Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. PLOS Glob Public Health. 2023 May 15;3(5):e0001009. doi: 10.1371/journal.pgph.0001009. eCollection 2023.
- Derived from this study: PubMed 36972694Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Ouattara M, Lebas E, Brogdon J, Nyatigo F, O'Brien KS, Porco TC, Barnighausen T, Arnold BF, Lietman TM, Oldenburg CE; NAITRE Study Team. Neonatal Azithromycin Administration and Growth during Infancy: A Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Mar 27;108(5):1063-1070. doi: 10.4269/ajtmh.22-0763. Print 2023 May 3.
- Derived from this study: PubMed 35692260Oldenburg CE, Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Koueta F, Lebas E, Brogdon J, Nyatigo F, Doan T, Porco TC, Arnold BF, Lietman TM; NAITRE Study Team. Neonatal azithromycin administration for prevention of infant mortality. NEJM Evid. 2022 Apr;1(4):EVIDoa2100054. doi: 10.1056/EVIDoa2100054. Epub 2022 Mar 17.
- Derived from this study: PubMed 34903190Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Lebas E, Brogdon J, Nyatigo F, Arnold BF, Lietman TM, Oldenburg CE. Antenatal care attendance and risk of low birthweight in Burkina Faso: a cross-sectional study. BMC Pregnancy Childbirth. 2021 Dec 13;21(1):825. doi: 10.1186/s12884-021-04310-6.
- Derived from this study: PubMed 31488494Sie A, Bountogo M, Nebie E, Ouattara M, Coulibaly B, Bagagnan C, Zabre P, Lebas E, Brogdon J, Godwin WW, Lin Y, Porco T, Doan T, Lietman TM, Oldenburg CE; NAITRE Study Group. Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 4;9(9):e031162. doi: 10.1136/bmjopen-2019-031162.
- Individual participant dataSharing planned: Yes. De-identified data will be available as per the Bill and Melinda Gates open access policy. Individual participant data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines.
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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.
Catherine E Oldenburg, PhD principal investigator
University of California, San Francisco
Tom M Lietman, MD principal investigator
University of California, San Francisco
Ali Sie, MD, PhD principal investigator
Centre de Recherche en Sante de Nouna, Burkina Faso
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 Azithromycin in people with Childhood Mortality, run by University of California, San Francisco at 1 site in Burkina Faso.
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 10 inclusion and 9 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 27 Jun 2023. 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 Burkina Faso. 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 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 Jun 2023). 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?
6 Month Mortality - All Cause (time frame: 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 NCT03682653, which also lists 5 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 27 Jun 2023.