The CARAMAL study could not assess the effectiveness of rectal artesunate in treating suspected severe malaria

CARAMAL was a large observational study which recorded mortality in children with suspected severe malaria before and after the roll-out of rectal artesunate in Nigeria, Uganda and the Democratic Republic of the Congo. The results of CARAMAL have had a huge impact on public health policy leading to a World Health Organization moratorium on the roll-out of rectal artesunate. The conclusion reported in the abstract uses strong causal language, stating that pre-referral RAS [rectal artesunate suppositories] had no beneficial effect on child survival. We argue that this causal interpretation of the study results is not justified. Data from the CARAMAL study inform chiefly on the strengths and weaknesses of referral systems in these three countries and do not inform reliably as to the beneficial effect of providing access to a known life-saving treatment.

Automated summary

CARAMAL is a large observational study conducted in Nigeria, Uganda, and the Democratic Republic of the Congo, which recorded mortality in children with suspected severe malaria. The study's results have had a significant impact on public health policy leading to a World Health Organization moratorium on the roll-out of rectal artesunate. However, we argue that the causal interpretation of the study results is not justified and that the data primarily inform on the strengths and weaknesses of referral systems in these three countries, rather than reliably informing on the beneficial effect of providing access to a known life-saving treatment.