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Prevention of Bacterial Infections in Newborn (PregnAnZI)

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ClinicalTrials.gov Identifier: NCT01800942
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Neonatal Infection Drug: Azithromycin and Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800942


Locations
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Gambia
Medical Research Council Unit
Fajara, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Anna Roca, PhD Medical Research Council Unit, The Gambia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01800942     History of Changes
Other Study ID Numbers: SCC1282
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by London School of Hygiene and Tropical Medicine:
prevention
bacterial infection
neonates
women in labour
Azithromycin

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections