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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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:

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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.

Mali1 site

Centre pour le Developpement des Vaccins - Mali
Bamako

Other trials in Mali

About this study

Official title: Sauver Avec l'Azithromycine en Traitant Les Femmes Enceintes et Les Enfants (SANTE)

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 groups in NCT03909737
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.

24 Sep 202031 Mar 2027

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.
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)

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