Impact Tanzania in vivo efficacy 2011

Full Title Impact Tanzania in vivo efficacy 2011: Therapeutic Drug Efficacy Monitoring  Short Title In vivo 2011   Project Leader Abdulnoor Mulokozi  Description The project is an open label randomized trial that will involve the current in use antimalarial first line policy both in mainland Tanzania and Zanzibar. Both will be compared to elicit day 28 clinical and/or parasitological responses. The current day 28 WHO invivo testing protocol will be implemented. The evaluation of other ACTs in use in the region or ones in the pipeline and have obtained regulatory approval may be considered. Historical framework of the East African Network for Monitoring Antimalarial treatments (EANMAT)-NMCP’ sentinel sites both in mainland and Zanzibar will be used. Partner institutions will carry out these activities and will form a task force for the monitoring process of testing. This task force will work together under the coordination of NMCP and Ifakara Health Institute (IHI). IHI will lead the task force by developing a work plan, budget, procure main supplies and will collate datasets and perform the data final analysis. The justification for this project is primarily, an assessment (invivo) of malarial infected individuals involves monitoring of clinical and parasitological outcomes of treatment over a certain period of time following the start of treatment. During the subsequent follow ups we shall check for the reappearance of parasites in the blood. Reappearance indicates reduced parasite sensitivity to the treatment drug. Given that a significant proportion of treatment failures do not appear until after day 14. It is therefore imperative to conclude that shorter observation periods lead to a considerable overestimation of the efficacy of the tested drug and thus WHO recommended day 28 or above follow up. The current recommended duration for follow-up of ≥28 days in areas of high as well as low to moderate transmission is associated with a considerable long follow up period the clinicians have to remain in the field in order to attain a moderate statistical significant number of patients. In light of this, invivo studies involving ACT that are still efficacious will tend to be highly costly to conduct because of maintaining clinical teams in field. In addition, assessments of anti-malarial treatment should also be on the basis of parasitological cure rates; this too has huge financial implication. Furthermore, assessments of blood or plasma levels of the anti-malarial should also be measured prospectively in order to distinguish drug resistance from treatment failure due to pharmacokinetic reasons. It is for these imperative reasons that at present most National Malarial Control Programmes (NMCP) in sub-Saharan region find it hard to lead alone the role of monitoring ACT drug resistance. Additionally, the project's goal is to ensure that ACT performance over time is correctly monitored in order to enable rapid and high quality containment strategy for the emergence of drug resistances to ACT. Furthermore, the project's objectives are as follows; 1. Undertake basic invivo operational research to fill knowledge gaps due to anti-malarial drug resistance and monitor anti-malarial first line policy 2. Maintain and update the ACT efficacy data base on their performance overtime 3. Measure microscopic and sub-microscopic rates of p.falciparum gametocytes 4. Create gene bank for markers of resistance to ACT that will be useful in the future containment or elimination phases.  Collaborators Honoroti Masanja                        Ifakara Health Institute                 Source of funding United States Agency for International Development (USAID)  Start Date February 2011                           End Date     January 2012

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