The investigators meeting of the PregnAnZI-2 trial took place on February 28th and March 1st at the MRC Unit The Gambia (MRCG) in Fajara. The main purpose of the meeting was to kick-off the start of the new multi-centre trial that will be coordinated by MRCG and implemented in The Gambia and Burkina Faso.
PregnAnZI-2 is a £ 2.2 Million trial funded by the Joined Global Trials Scheme (MRC, Welcome Trust, DfId). The trial is the continuation of a former trial designed and conducted by MRCG. PregnAnZI, which showed that Azithromycin given during labour decreases bacterial colonization in the mothers and offspring during the entire neonatal period and decreases the occurrence of infections in mothers and newborns.
The new trial, PregnAnZI-2, has been designed to assess the effect of a single dose of Azithromycin (AZI) given to women during labour on neonatal mortality. Additional objectives of the trial will assess the effect of the intervention on maternal and neonatal sepsis as well as impact on children malnutrition during the first year of life.
The two day investigators’ meeting was attended by three international co-investigators from Burkina Faso and United Kingdom, as well as MRCG investigators and other MRCG staff that will be involved in the implementation of the trial. A member of the Steering Committee from the Centers for Disease Control (CDC) in Atlanta joined the meeting via WebEx.
Dr Anna Roca, Chief Investigator, MRCG, gave a detailed presentation about the history of PregnAnZI, including results from the first trial. Tahita Marc Christian, Clinical Trial Coordinator, Clinical Research Unit of Nanoro (CRUN), Burkina Faso, gave a detailed presentation on the preparedness of CRUN for conducting the PregnAnZI-2 Trial at various health clinics across Nanoro, central Burkina Faso.
Co-investigators and other members of the MRCG, advanced on the final design of the trial and discussed aspects of the implementation of this ambitious new trial that will recruit 12,500 women in labour and their offspring within a period of 3 years. Long way to go!