Neonatal DeathPhase 4VIVANTNCT05763693
Vitality in Infants Via Azithromycin for Neonates Trial
A Phase 4 study testing Azithromycin at Baseline and Azithromycin at Day 21 in people with Neonatal Death and Infectious Disease, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial summary
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Read more about this study
- Who is it for?
- Ages 1 day to 27 days
- Conditions the study is for
- Neonatal Death, Infectious Disease, Nutritional Deficiency
- What is being tested?
- Azithromycin at Baseline and Azithromycin at Day 21
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,000 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Apr 2026to Apr 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 day to 27 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 1-27 days old
- Birthweight < 2500 g and/or weight-for-height Z score <- 2 standard deviations at enrollment
- Weigh at least 1500 g at time of enrollment
- Able to feed orally
- Family intends to stay in the study area for at least 6 months
- Written informed consent from at least one caregiver
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- Afebrile
- Caregiver at least 18 years old
- No known allergy to macrolides
- No hepatic failure manifested by neonatal jaundice
- Not currently an inpatient at the clinic
- Not being transferred to a hospital for clinical complications
Who cannot join
- Birthweight > 2500 g
- Weigh less than 1500 g at time of enrollment
- Unable to feed orally
- Family planning to move within 6 months
- Mother/ caregiver not willing to participate
- Allergic to macrolides
Show all 9Show fewer
- Hepatic failure manifested by neonatal jaundice
- Currently being seen as an inpatient at the clinic
- Currently being transferred to a hospital for clinical complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burkina Faso1 site
Centre de Recherche en santé de Nouna
Nouna, BP02
Ali Sie, PhD, sieali@yahoo.fr
Mamadou Bountogo, MD, drbountogo@yahoo.fr
About this study
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.
Read the detailed description
The Vitality in Infants Via Azithromycin for Neonates Trial (VIVANT) is a proposed 1:1:1:1 randomized placebo-controlled trial to determine whether a single oral dose of azithromycin (20 mg/kg) administered either in the early or late neonatal/early infancy period is effective for improving infant growth outcomes, and if there is additional benefit of administration of a second dose of azithromycin 21 days after the first dose (Figure 2). This intervention schedule will allow for several questions related to azithromycin administration in neonates to be answered efficiently, including:
- A single oral azithromycin dose compared to placebo, administered either earlier or later during the neonatal period or early infancy.
- Two oral doses of azithromycin spaced 21 days apart compared to placebo.
- Two oral doses of azithromycin compared to a single oral dose of azithromycin, which would allow for determination of any dose-dependent effects.
- An early dose of azithromycin compared to a later dose of azithromycin, which may be beneficial if administration of azithromycin earlier during the neonatal period increases risk of IHPS
- Conditions
- Neonatal Death, Infectious Disease, Nutritional Deficiency
- Being tested
- Azithromycin at Baseline, Azithromycin at Day 21, Placebo at Baseline, Placebo at Day 21
- Keywords
- Low birth weight, underweight neonates
- Medical subject headings
- Perinatal Death, Communicable Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin at BaselineDrug
this group will be randomized to receive a single oral dose of azithromycin (20mg/kg) at baseline
Azithromycin at Day 21Drug
this group will be randomized to receive a single oral dose of azithromycin (20mg/kg) at the day 21 visit
Placebo at BaselineOther
this group will be randomized to receive Placebo at baseline
Placebo at Day 21Other
This group will be randomized to receive Placebo at the day 21 visit
| Study group | Role | What they receive |
|---|---|---|
| Azithro-Azithro | Active comparator | A single oral dose of azithromycin (20 mg/kg) at baseline and a single oral dose of azithromycin (20 mg/kg) at the day 21 follow-up Receives: Drug: Azithromycin at Baseline; Drug: Azithromycin at Day 21 |
| Azithro-Placebo | Active comparator | A single oral dose of azithromycin (20 mg/kg) at baseline and a single oral dose of matching placebo at the day 21 follow-up Receives: Drug: Azithromycin at Baseline; Other: Placebo at Day 21 |
| Placebo-Azithro | Active comparator | A single oral dose of placebo at baseline and a single oral dose of azithromycin (20 mg/kg) at the day 21 follow-up Receives: Drug: Azithromycin at Day 21; Other: Placebo at Baseline |
| Placebo-Placebo | Placebo comparator | A single oral dose of placebo at baseline and a single oral dose of matching placebo at the day 21 follow-up Receives: Other: Placebo at Baseline; Other: Placebo at Day 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain at 6 month of age
Weight for Age Z score
Measured: 6 months
Secondary outcomes (2)
IHPS
Signs of IHPS will be screened at the 21 day follow up visit. diagnosed cases of IHPS will be reported by arm
Measured: 21 days
Mortality at 6 months
Vital status will be verified at each follow up visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study startApr 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DeathStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
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
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763693
- Sponsor's protocol ID
- 21-34232
- Acronym
- VIVANT
- Status last verified
- Aug 2025
- First submitted
- 24 Feb 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitality in Infants Via Azithromycin for Neonates Trial
- ClinicalTrials.gov ID
- NCT05763693
- Acronym / sponsor ID
- VIVANT / 21-34232
- Conditions
- Neonatal Death, Infectious Disease, Nutritional Deficiency
- Keywords
- Low birth weight, underweight neonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 10 Mar 2023 (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.
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.
Detailed description
The Vitality in Infants Via Azithromycin for Neonates Trial (VIVANT) is a proposed 1:1:1:1 randomized placebo-controlled trial to determine whether a single oral dose of azithromycin (20 mg/kg) administered either in the early or late neonatal/early infancy period is effective for improving infant growth outcomes, and if there is additional benefit of administration of a second dose of azithromycin 21 days after the first dose (Figure 2). This intervention schedule will allow for several questions related to azithromycin administration in neonates to be answered efficiently, including:
- A single oral azithromycin dose compared to placebo, administered either earlier or later during the neonatal period or early infancy.
- Two oral doses of azithromycin spaced 21 days apart compared to placebo.
- Two oral doses of azithromycin compared to a single oral dose of azithromycin, which would allow for determination of any dose-dependent effects.
- An early dose of azithromycin compared to a later dose of azithromycin, which may be beneficial if administration of azithromycin earlier during the neonatal period increases risk of IHPS
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Azithro-Azithro | Active comparator | Drug: Azithromycin at Baseline, Drug: Azithromycin at Day 21A single oral dose of azithromycin (20 mg/kg) at baseline and a single oral dose of azithromycin (20 mg/kg) at the day 21 follow-up |
| Azithro-Placebo | Active comparator | Drug: Azithromycin at Baseline, Other: Placebo at Day 21A single oral dose of azithromycin (20 mg/kg) at baseline and a single oral dose of matching placebo at the day 21 follow-up |
| Placebo-Azithro | Active comparator | Drug: Azithromycin at Day 21, Other: Placebo at BaselineA single oral dose of placebo at baseline and a single oral dose of azithromycin (20 mg/kg) at the day 21 follow-up |
| Placebo-Placebo | Placebo comparator | Other: Placebo at Baseline, Other: Placebo at Day 21A single oral dose of placebo at baseline and a single oral dose of matching placebo at the day 21 follow-up |
Who may qualify
- Ages
- 1 day to 27 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Aged 1-27 days old
- Birthweight < 2500 g and/or weight-for-height Z score <- 2 standard deviations at enrollment
- Weigh at least 1500 g at time of enrollment
- Able to feed orally
- Family intends to stay in the study area for at least 6 months
Key exclusion criteria (9 listed)
- Birthweight > 2500 g
- Weigh less than 1500 g at time of enrollment
- Unable to feed orally
- Family planning to move within 6 months
- 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 |
|---|---|---|
| Azithromycin at Baselinethis group will be randomized to receive a single oral dose of azithromycin (20mg/kg) at baseline | Drug | Azithro-Azithro, Azithro-Placebo |
| Azithromycin at Day 21this group will be randomized to receive a single oral dose of azithromycin (20mg/kg) at the day 21 visit | Drug | Azithro-Azithro, Placebo-Azithro |
| Placebo at Baselinethis group will be randomized to receive Placebo at baseline | Other | Placebo-Azithro, Placebo-Placebo |
| Placebo at Day 21This group will be randomized to receive Placebo at the day 21 visit | Other | Azithro-Placebo, Placebo-Placebo |
Primary outcome
weight gain at 6 month of age
Time frame: 6 months
Weight for Age Z score
2 secondary outcomes
IHPS
Time frame: 21 days
Mortality at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Catherine Oldenburg, ScD principal investigator
University of California, San Francisco
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 at Baseline and Azithromycin at Day 21 in people with Neonatal Death and Infectious Disease, 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 12 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: opening soon, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie Lebas, RN ((415) 476-1442, elodie.lebas@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain at 6 month of age (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.