NECT FIELD |
(Nifurtimox-eflornithine combination trials for human African trypanosomiasis)
The pivotal Phase 3 NECT trial was successfully concluded in 2008 and demonstrated that the Nifurtimox-Eflornithine Combination Therapy is as effective and safe but easier to use than standard eflornithine monotherapy. In March 2009, NECT was included in the WHO Essential Medicines List (EML) as treatment for second-stage sleeping sickness. The WHO shipped the first batch of NECT kits with all needed drugs and medical material to the Democratic Republic of the Congo (DRC) and is supporting its introduction as first-line treatment in other endemic countries.
However, to become widely used in the remote rural settings of sleeping sickness treatment facilities, logistical barriers must be overcome, health care staff well instructed and the safety profile under such conditions better known. For these reasons, we are conducting a Phase 3b clinical trial, NECT FIELD*, to broaden the safety information and strengthen the evidence base for the applicability of NECT under real-life field conditions. For the first time children, pregnant and lactating women are also included and information on the treatment of these special populations is being collected. DNDi sponsors the trial and the Swiss TPH-PMU is responsible for the overall implementation and monitoring. Together with the DRC sleeping sickness control programme PNLTHA, MSF Switzerland and IHMT (Institute of Tropical Medicine and Hygiene, Lisbon) the health care centre staff were specifically trained for patient management with NECT.
Between April 2009 and June 2010 a total of 630 patients were recruited in 6 sleeping sickness treatment centres and reference hospitals in the DRC Provinces of Bandundu and Kasai Oriental. The clinical tolerability, feasibility and effectiveness are being assessed. The safety analysis is ongoing and the efficacy will be available by mid 2012 when the 2 years of patient follow up is completed.
In June 2010, we concluded part of the feasibility assessment of NECT implementation in remote rural conditions of the DRC. Clearly, NECT is appreciated as first line treatment by all staff interviewed. But minimal levels of human resources, thorough staff training and comprehensive instructions/guidelines are absolutely needed and logistical barriers in the supply chain management must be overcome
*Clinical study to assess the clinical tolerability, feasibility and effectiveness under field conditions of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase