Stillbirths and Infant MortalityPhase 4SANTENCT03909737
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali
A Phase 4 study testing Azithromycin to pregnant women and Azithromycin to infants in people with Stillbirths and Infant Mortality, run by University of Maryland, Baltimore at 1 site in Mali.
Trial summary
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stillbirths and Infant Mortality
- What is being tested?
- Azithromycin to pregnant women and Azithromycin to infants
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99,700 participants
- Where
- 1 siteMali
- Study dates
- 24 Sep 2020to 31 Mar 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women:
- Participant is attending an ANC visit between 13 and 37 weeks gestation, with gestational age estimated using fundal height measurements and/or maternal report of quickening, at a participating health facility.
- Participant is able to understand and comply with planned study procedures.
- Participant has provided informed consent prior to initiation of any study procedures.
- Participant intends to reside in the study area until her newborn infant is at least 12 months old.
- Infants:
Show all 11Show fewer
- Enrollment of pregnant women and their unborn infants will happen simultaneously. Infants attending routine immunization visits at eligible health facilities whose mothers were not enrolled in the study will be eligible for enrollment in the supplemental infant cohort within the rural study cohort with the following inclusion criteria:
- Infant is <12 mo attending a DTP-1 routine vaccination visit at a participating health facility.
- Parent or guardian is able to understand and comply with planned study procedures.
- Parent or guardian has provided informed consent prior to initiation of any study procedures.
- Parent or guardian intends to reside in the study area until participant is at least 12 months old.
Who cannot join
- Allergy to macrolides or azalides.
- Any condition that, in the opinion of the investigator, might compromise the well-being of the participant or compliance with study procedures.
- Medical treatment that requires administration of azithromycin (this can be a temporary exclusion if the drug is later discontinued).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sauver Avec l'Azithromycine en Traitant Les Femmes Enceintes et Les Enfants (SANTE)
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world.
Read the detailed description
This trial will assess the efficacy of oral azithromycin given during routine health care visits in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world. Using an individually randomized placebo-controlled double-masked trial design, pregnant women will receive a single dose of oral azithromycin or placebo at their second and/or third trimester antenatal care visits and during labor, and to infants at their DPT-1 and DPT-3 vaccination visits, which occur at approximately 6 and 14 weeks of age, respectively. The two co-primary outcomes are (1A) a composite outcome of stillbirths and mortality through 6-12 months of age and (1B) mortality between 6 weeks and 6-12 months of age. The study sample size is powered to detect a 20% relative reduction in both of the two co-primary outcomes. The study is designed to inform policymakers regarding the effectiveness of azithromycin for the prevention of stillbirth and infant mortality in both urban and rural parts of the country when administered during routine antenatal and intrapartum care and infant immunization visits. To achieve this aim, three cohorts will be enrolled: a mother-infant cohort in a rural part of the country with infant mortality rates that are higher than the national average, a supplemental infant-only cohort enrolled form the same rural communities, and third urban mother-infant cohort residing in Bamako, Mali's capital. Sub studies designed to elucidate the protective mechanisms of azithromycin treatment will be embedded within the larger study and will be added in the future.
- Conditions
- Stillbirths and Infant Mortality
- Being tested
- Azithromycin to pregnant women, Azithromycin to infants, Placebo to pregnant women, Placebo to infants, No intervention to pregnant women
- Medical subject headings
- Stillbirth, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin to pregnant womenDrug
Azithromycin to pregnant women at antenatal care visits and during delivery
Azithromycin to infantsDrug
Azithromycin to infants at 6 and 14 week EPI visits
Placebo to pregnant womenOther
Placebo to pregnant women at antenatal care visits and during delivery
Placebo to infantsOther
Placebo to infants at 6 and 14 week EPI visits
No intervention to pregnant womenOther
No intervention to pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin to pregnant women and azithromycin to infants | Experimental | 2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week Expanded Programme on Immunization (EPI) visits Receives: Drug: Azithromycin to pregnant women; Drug: Azithromycin to infants |
| Azithromycin to pregnant women and placebo to infants | Experimental | 2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits Receives: Drug: Azithromycin to pregnant women; Other: Placebo to infants |
| Placebo to pregnant women and azithromycin to infants | Experimental | Oral placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits Receives: Drug: Azithromycin to infants; Other: Placebo to pregnant women |
| Placebo to pregnant women and placebo to infants | Placebo comparator | Placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits Receives: Other: Placebo to pregnant women; Other: Placebo to infants |
| No intervention to pregnant women and azithromycin to infants | Experimental | No intervention to pregnant women and 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits Receives: Drug: Azithromycin to infants; Other: No intervention to pregnant women |
| No intervention to pregnant women and Placebo to infants | Placebo comparator | No intervention to pregnant women and placebo to infants at 6 and 14 week EPI visits Receives: Other: Placebo to infants; Other: No intervention to pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stillbirths and infant mortality through 6-12 months of age
Delivery outcomes assessed at intrapartum study visit and infant vital status assessed at 6 and 12 month study visits.
Measured: 6 to 12 months
Rate of infant mortality between 6 weeks and 12 months of age
Infant vital status will be assessed at 6 and 12 month study visits.
Measured: 6 weeks to 12 months
Secondary outcomes (3)
Gestational age at birth
Gestational age will be estimated at enrollment and at delivery.
Measured: 3-6 months
Birth weight
Birth weight will be measured.
Measured: 3-6 months
The incremental cost-effectiveness ratio of adding azithromycin to standard of care in Mali
Costs associated with the delivery of azithromycin will be measured and the cost-effectiveness ratio will be estimated using efficacy data from the trial.
Measured: 6 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start24 Sep 2020
- Primary completion1 Mar 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stillbirths and Infant MortalityStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Model description
- This study will enroll three study cohorts: (1) a rural cohort of pregnant mother-infant pairs based in the southern region of Sikasso where infant mortality rates are higher than the national average (2) a rural cohort of only infants enrolled from the same communities as the mother-infant pairs, and (3) an urban cohort of pregnant mother-infant pairs based in Bamako. Cohort 1 will use a 2x2 factorial design. The pregnant women will be randomized to receive either oral azithromycin or placebo, and their infants, once born, will be separately randomized to receive either oral azithromycin or placebo. Cohorts 2 and 3 will use a parallel design. In Cohort 2, infants will be randomized to either azithromycin or placebo. In Cohort 3, mother-infant pairs will be randomized in tandem to either azithromycin or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Karen Kotloff, University of Maryland, Baltimore
- Investigators
- Karen L Kotloff, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909737
- Sponsor's protocol ID
- HP-00084242
- Acronym
- SANTE
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Driscoll AJ, Haidara FC, Tapia MD, Deichsel EL, Samake OS, Bocoum T, Bailey JA, Fitzpatrick MC, Goldenberg RL, Kodio M, Moulton LH, Nasrin D, Onwuchekwa U, Shaffer AM, Sow SO, Kotloff KL. Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2x2 factorial randomised controlled trial in Mali. BMJ Open. 2023 Aug 30;13(8):e067581. doi: 10.1136/bmjopen-2022-067581.
PubMed 37648393
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sauver Avec l'Azithromycine en Traitant Les Femmes Enceintes et Les Enfants (SANTE)
- ClinicalTrials.gov ID
- NCT03909737
- Acronym / sponsor ID
- SANTE / HP-00084242
- Conditions
- Stillbirths and Infant Mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99,700 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Apr 2019 (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.
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world.
Detailed description
This trial will assess the efficacy of oral azithromycin given during routine health care visits in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world. Using an individually randomized placebo-controlled double-masked trial design, pregnant women will receive a single dose of oral azithromycin or placebo at their second and/or third trimester antenatal care visits and during labor, and to infants at their DPT-1 and DPT-3 vaccination visits, which occur at approximately 6 and 14 weeks of age, respectively. The two co-primary outcomes are (1A) a composite outcome of stillbirths and mortality through 6-12 months of age and (1B) mortality between 6 weeks and 6-12 months of age. The study sample size is powered to detect a 20% relative reduction in both of the two co-primary outcomes. The study is designed to inform policymakers regarding the effectiveness of azithromycin for the prevention of stillbirth and infant mortality in both urban and rural parts of the country when administered during routine antenatal and intrapartum care and infant immunization visits. To achieve this aim, three cohorts will be enrolled: a mother-infant cohort in a rural part of the country with infant mortality rates that are higher than the national average, a supplemental infant-only cohort enrolled form the same rural communities, and third urban mother-infant cohort residing in Bamako, Mali's capital. Sub studies designed to elucidate the protective mechanisms of azithromycin treatment will be embedded within the larger study and will be added in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This study will enroll three study cohorts: (1) a rural cohort of pregnant mother-infant pairs based in the southern region of Sikasso where infant mortality rates are higher than the national average (2) a rural cohort of only infants enrolled from the same communities as the mother-infant pairs, and (3) an urban cohort of pregnant mother-infant pairs based in Bamako. Cohort 1 will use a 2x2 factorial design. The pregnant women will be randomized to receive either oral azithromycin or placebo, and their infants, once born, will be separately randomized to receive either oral azithromycin or placebo. Cohorts 2 and 3 will use a parallel design. In Cohort 2, infants will be randomized to either azithromycin or placebo. In Cohort 3, mother-infant pairs will be randomized in tandem to either azithromycin or placebo.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin to pregnant women and azithromycin to infants | Experimental | Drug: Azithromycin to pregnant women, Drug: Azithromycin to infants2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week Expanded Programme on Immunization (EPI) visits |
| Azithromycin to pregnant women and placebo to infants | Experimental | Drug: Azithromycin to pregnant women, Other: Placebo to infants2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits |
| Placebo to pregnant women and azithromycin to infants | Experimental | Drug: Azithromycin to infants, Other: Placebo to pregnant womenOral placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits |
| Placebo to pregnant women and placebo to infants | Placebo comparator | Other: Placebo to pregnant women, Other: Placebo to infantsPlacebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits |
| No intervention to pregnant women and azithromycin to infants | Experimental | Drug: Azithromycin to infants, Other: No intervention to pregnant womenNo intervention to pregnant women and 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits |
| No intervention to pregnant women and Placebo to infants | Placebo comparator | Other: Placebo to infants, Other: No intervention to pregnant womenNo intervention to pregnant women and placebo to infants at 6 and 14 week EPI visits |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Participant is attending an ANC visit between 13 and 37 weeks gestation, with gestational age estimated using fundal height measurements and/or maternal report of quickening, at a participating health facility.
- Participant is able to understand and comply with planned study procedures.
- Participant has provided informed consent prior to initiation of any study procedures.
- Participant intends to reside in the study area until her newborn infant is at least 12 months old.
- Enrollment of pregnant women and their unborn infants will happen simultaneously. Infants attending routine immunization visits at eligible health facilities whose mothers were not enrolled in the study will be eligible for enrollment in the supplemental infant cohort within the rural study cohort with the following inclusion criteria:
Key exclusion criteria (3 listed)
- Allergy to macrolides or azalides.
- Any condition that, in the opinion of the investigator, might compromise the well-being of the participant or compliance with study procedures.
- Medical treatment that requires administration of azithromycin (this can be a temporary exclusion if the drug is later discontinued).
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 to pregnant womenAzithromycin to pregnant women at antenatal care visits and during delivery | Drug | Azithromycin to pregnant women and azithromycin to infants, Azithromycin to pregnant women and placebo to infants |
| Azithromycin to infantsAzithromycin to infants at 6 and 14 week EPI visits | Drug | Azithromycin to pregnant women and azithromycin to infants, No intervention to pregnant women and azithromycin to infants, Placebo to pregnant women and azithromycin to infants |
| Placebo to pregnant womenPlacebo to pregnant women at antenatal care visits and during delivery | Other | Placebo to pregnant women and azithromycin to infants, Placebo to pregnant women and placebo to infants |
| Placebo to infantsPlacebo to infants at 6 and 14 week EPI visits | Other | Azithromycin to pregnant women and placebo to infants, No intervention to pregnant women and Placebo to infants, Placebo to pregnant women and placebo to infants |
| No intervention to pregnant womenNo intervention to pregnant women | Other | No intervention to pregnant women and Placebo to infants, No intervention to pregnant women and azithromycin to infants |
Primary outcome
Rate of stillbirths and infant mortality through 6-12 months of age
Time frame: 6 to 12 months
Delivery outcomes assessed at intrapartum study visit and infant vital status assessed at 6 and 12 month study visits.
Rate of infant mortality between 6 weeks and 12 months of age
Time frame: 6 weeks to 12 months
Infant vital status will be assessed at 6 and 12 month study visits.
3 secondary outcomes
Gestational age at birth
Time frame: 3-6 months
Birth weight
Time frame: 3-6 months
The incremental cost-effectiveness ratio of adding azithromycin to standard of care in Mali
Time frame: 6 to 18 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 7 Aug 2026.
- Derived from this study: PubMed 37648393Driscoll AJ, Haidara FC, Tapia MD, Deichsel EL, Samake OS, Bocoum T, Bailey JA, Fitzpatrick MC, Goldenberg RL, Kodio M, Moulton LH, Nasrin D, Onwuchekwa U, Shaffer AM, Sow SO, Kotloff KL. Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2x2 factorial randomised controlled trial in Mali. BMJ Open. 2023 Aug 30;13(8):e067581. doi: 10.1136/bmjopen-2022-067581.
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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.
Karen L Kotloff, MD principal investigator
University of Maryland, Baltimore
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 to pregnant women and Azithromycin to infants in people with Stillbirths and Infant Mortality, run by University of Maryland, Baltimore at 1 site in Mali.
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 11 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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 Mali. 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?
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?
Rate of stillbirths and infant mortality through 6-12 months of age (time frame: 6 to 12 months). 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 NCT03909737, 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 7 Aug 2026.