Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT03199547
• Date of registration: 23/06/2017
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death PregnAnZI-2
• Scientific title: Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death: a Phase III Double-blind Randomized Clinical Trial
• Date of first enrolment: October 21, 2017
• Target sample size: 11985
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03199547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Burkina Faso, Gambia

Contacts

• Name: Anna Roca, PhD
• Affiliation: MRC Unit The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

Pregnant women in labour (aged 16 years or more) attending the study health facilities for
delivery who have previously given consent and willing to continue participation

Exclusion Criteria:

Known HIV infection. Any chronic or acute conditions of the women that might interfere with
the study as judged by the research clinician.

Planned travelling out of the catchment area during the following 28 days Planned caesarean
section or known required referral Known severe congenital malformation Intrauterine death
confirmed before randomisation Known allergy to macrolides Already participating in another
trial



Age minimum: 16 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Neonatal SEPSIS

Intervention(s)

Drug: Placebo Oral Tablet

Drug: Azithromycin

Primary Outcome(s)

neonatal sepsis and mortality [Time Frame: from Birth to Day 28]

Secondary Outcome(s)

Neonatal sepsis-Early-onset of Culture confirmed sepsis [Time Frame: Day 1- Day 3]

Infant mortality [Time Frame: Birth to 12 Months]

All-cause maternal hospitalisation [Time Frame: Day 1 to day 28]

All-caused hospitalisation during the follow up period [Time Frame: 28 days forAll study participants will be followed for 28 days except those participating in the sub-studies; 4 months for children in carriage sub-study; 12 months for children participating in the anthropometrical sub-stud]

Malnutrition and Severe malnutrition [Time Frame: At 6, 9 and 12 months of age]

Late-onset culture confirmed sepsis [Time Frame: Day 3 - Day 28]

Post-partum sepsis- Women [Time Frame: Day 1 to Day 28]

Early-onset clinical sepsis [Time Frame: Day 1- Day 3]

Late-onset clinical sepsis [Time Frame: Day 3- Day 28]

Secondary ID(s)

SCC 1532

Source(s) of Monetary Support

Please refer to primary and secondary sponsors