IND Protocol: Intravenous Artesunate for Treatment of Severe Malaria in the United States
The primary purpose of this protocol is to make intravenous artesunate available for the treatment of severe malaria. Please download and print the two documents listed below. As soon as the consent form, the FDA form 1572, and the demographics and enrollment forms have been completed, please fax them to the CDC Malaria Branch at (404) 718-4815. You can use the additional forms to assist in the management of the patient but you are not required to send these completed forms to CDC unless you choose to, or if you need to request additional artesunate doses, or if there has been an adverse reaction to the medicine. Please report any adverse reactions, if any occur, as soon as possible as described in the protocol.
Data collection and storage for these cases will be handled by CDC in a secure database.