A trial in The Gambia (PregnAnZI-1) has shown that taking oral azithromycin during labour reduces bacterial colonization in women and their newborn. After the promising results obtained in the proof-of-concept trial (PregnAnZI-1), the Joint Global Trials scheme between MRC UK, WellcomeTrust and Department for International Development UK has funded a larger trial to assess the effect of the intervention on neonatal mortality and maternal and neonatal sepsis, PregnAnZI-2. The ongoing trial is taking place in The Gambia and Burkina Faso. The study is also assessing the risk of the use of azithromycin in establishing antibiotic resistance in the community.
Although azithromycin has been used for several preventive strategies, the Unit was the first institution to assess the use azithromycin to prevent neonatal sepsis and is pioneer on the potential of azithromycin for these groups. Therefore, both PregnAnZI-1 and PregnAnZI-2 present a unique opportunity to maximize outputs and generate information of the public health potential of this strategy.
The $1.3 million USD grant is to leverage the already funded PregnAnZI trials supporting six ancillary studies that will look at the impact of intra-partum administration, specifically on the:
- longer-term impact on growth in children at five years of age (PregnAnZI-1)
- longer-term impact on child growth, anaemia, morbidity, and mortality beyond the age of 12 months (PregnAnZI-2)
- maternal and neonatal microbiome (PregnAnZI-1 and PregnAnZI-2)
- assessment of azithromycin concentration in neonatal blood (PregnAnZI -2)
- generating refined understanding of bacterial vaginal carriage and subsequent neonatal disease in West Africa (PregnAnZI -2)
- long term effect of the intervention on neurological development among normal deliveries as well as deliveries with birth asphyxia and severe birth asphyxia (PregnAnI-2)
“Our initial results have created an international interest in our proposed strategy of giving azithromycin during labour to improve maternal and neonatal outcomes. We have designed a large study to answer many questions on the potential public health of this intervention. And now, thanks to the additional support from BMGF, we will be able to answer additional clinical and microbiological questions that will be important for policy if the intervention shows to be efficacious.” Dr Roca commented.