5 July 2019
The MRC Unit The Gambia at the LSHTM hosted the first Maternal Azithromycin Research (MAR) Harmonization meeting with investigators from around the world, from 26th to 28th June 2019.
The MAR meeting was organized and chaired by Dr Anna Roca, PregnAnZI-2 Principal Investigator, and included other investigators from the MRC Unit The Gambia at LSHTM, the University of Maryland Medical School, University of Alabama, Research Triangle Institute International, the University of Melbourne, the University of San Francisco, the Liverpool School of Tropical Medicine and PregnAnZI-2 study team members from both The Gambia and Burkina Faso as well as the PregnAnZI statistician from LSHTM. The meeting also included experts from the Centre for Disease Control in Atlanta and a World Health Organization advisor. The objectives of the meeting were to harmonize procedures and definitions for different studies beyond the PregnAnZI trials which will assess intra-partum, maternal (i.e. antenatal care visits) and/or neonatal azithromycin administration. Topics such as inclusion and exclusion criteria, endpoints, and new technologies to detect sepsis and AMR were discussed.
The results of the PregnAnZI-1 trial initiated and conducted in The Gambia have sparked increasing interest in the use of maternal azithromycin for decreasing infections in both mothers and their new-borns. The PregnAnZI trials’ strategy (funded by MRC-UK, WT, DFID and BMGF) is to administer azithromycin during labour.
Principal Investigators of the different trials presented their projects at the start the meeting. Further discussions during the two days focused on the importance of using these trials to evaluate the holistic impact of this intervention, both benefits and risks. Expected health benefits include potential short-term improvements in sepsis and mortality, and possible long-term benefits include improved nutritional and neurological development. The main potential risks discussed were the induction of AMR and dysbiosis in the microbiome.
Commenting on the impact and success of the meeting, Unit Director Professor Umberto D’Alessandro stated, “Administration of azithromycin to pregnant women, either during labor or pregnancy, may have a substantial beneficial effect on the health of the mother and offspring. The research groups investigating this intervention met and discussed protocols and study procedures. This MAR meeting was held in The Gambia, thanks to the support of the Gates Foundation. I believe it has been a success and has resulted in the creation of an investigators’ consortium that would be able to facilitate the translation of the trials’ results, if positive, into health policies.”
Similarly, Dr Roca noted, “It’s been an enriching experience to host the first MAR meeting in The Gambia and contrast our experience with other groups. We are all very excited about the potential benefits of the use of prophylactic maternal azithromycin but also understand that this is a provocative approach and has potential risks. All the groups will extensively evaluate the potential risk of inducing AMR as a result of the intervention, to eventually balance them with the health benefits.”
The meeting concluded with a dynamic session on the next steps for collaboration that highlighted remaining research gaps. The final day of the meeting included a visit to the Clinical Labs and thePregnAnZI-2 study site at the Serrekunda Health Centre. The Clinical Trial Coordinator of the PregnAnZI-2 trial, Dr Bully Camara described the visit to the site as “an excellent opportunity to showcase and share our experiences in conducting such a demanding clinical trialat the lowest cadre of public service delivery in The Gambia. We can only hope that the visit was as beneficial and informative to our esteemed guests as it was to us.”