“Pfizer has discontinued the study program of Azithromycin-Chloroquine (AZCQ) for the development of an Intermittent Preventive Therapy of malaria in pregnancy based on the results of a pre-specified interim analysis by an External Data Monitoring Committee (EDMC) of study A0661158. The study compared the efficacy and safety of AZCQ vs the current standard of care Sulfadoxine-Pyrimethamine (SP), against previous reports of growing resistance to SP in the scientific literature.
Based on the interim analysis, it was concluded that the study would be unlikely to achieve its objective of demonstrating superior AZCQ efficacy compared to SP. Overall the efficacy was similar between the two groups, due to a better than expected performance of SP. The overall rate of sub-optimal pregnancy outcomes across the AZCQ and SP treatment arms, including low birth weight, was also appreciably lower than expected possibly due to the high rate of bednet use as prescribed by the study protocol. There seemed to be a higher rate of discontinuation amongst patients receiving AZCQ versus SP. There were no safety concerns raised in the review of the study program.”
- Statement by Pfizer, September 2013
Study subjects have been switched to standard of care therapy and will be followed up for serious adverse events and exposure in utero. A manuscript is currently in preparation and will be submitted for publication to ensure the results of this study are available to the global public health community.
The IPTp malaria program was performed with close collaboration among Pfizer, Medicines for Malaria Venture (MMV) and London School of Hygiene and Tropical Medicine and supported in part by a grant from MMV.