Prevention of Bacterial Infections in Newborn (PregnAnZI)

March 20, 2018 updated by: London School of Hygiene and Tropical Medicine

Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial

The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.

Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.

Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.

If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.

The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.

The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.

This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

829

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gambia
      • Fajara, Gambia
        • Medical Research Council Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women (aged 18 to 45 years)
  • in labour
  • attending a health centre in western Gambia for delivery

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 2 months (follow-up period)
  • Planned caesarean section
  • Known required referral
  • Known multiple pregnancy
  • Known severe congenital malformation
  • Intrauterine death confirmed before randomization
  • Known allergy to macrolides
  • Consumption of antibiotic within the week before randomisation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo

830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo.

A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour.
Drug: Azithromycin and Placebo
A single oral dose of 2g of Azithromycin will be given to the women in labour
Experimental: Azithromycin

830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo.

A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour.
Drug: Azithromycin and Placebo
A single oral dose of 2g of Azithromycin will be given to the women in labour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus
Time Frame: 6 days
The primary outcome is the prevalence of nasopharyngeal carriage of the newborn at the age of six days for any of the following bacteria: 1) Group B Streptococci, 2) S.pneumoniae and 3) S.aureus.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal bacterial Group B Streptococci(GBS), S.pneumoniae and S.aureus) carriage at day six post-delivery. Vaginal bacterial (GBS, S.pneumoniae and S.aureus) carriage at day 8-10 post-delivery
Time Frame: 6-13 days

The secondary outcomes are the prevalence of:

- Newborn's nasopharyngeal bacterial Group B Streptococci (GBS), S.pneumoniae and S.aureus) carriage at any other scheduled visit.

Bacterial isolates Group B Streptococci (GBS), S.pneumoniae and S.aureus), both from the newborn and the mother, non-susceptible to macrolides, from different study samples and time-points.

Bacterial Group B Streptococci (GBS), S.pneumoniae and S.aureus) carriage in the breast milk at any scheduled visit.

Purulent conjunctivitis within the first 4 weeks of life. Purulent Chlamydial conjunctivitis. AZI levels in breast milk on day 3 and 6 post-delivery.
6-13 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Investigators

  • Principal Investigator: Anna Roca, PhD, Medical Research Council Unit, The Gambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCC1282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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