Malaria Therapeutic Efficacy Study (TES) Kenya
Condition: Uncomplicated Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial
      medicines should be routinely carried out and data made available for decision-making due to
      the threat of emergence and spread of artemisinin resistance in malaria-endemic countries,
      especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is
      conducting the TES to determine the efficacy of artemether lumefantrine (AL), and
      dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated
      malaria in Kenya. The objective of this study is to inform the decisions or actions made by a
      public health authority (Kenya Ministry of Health) to inform decision on revision of the
      antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with
      funding and technical oversight from US President's Malaria Initiative (PMI) through USAID
      and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in
      the treatment of children with uncomplicated malaria. The study is being conducted by Kenya
      MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.
    

Detailed description: 
      WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial
      medicines should be routinely carried out and data made available for decision-making due to
      the threat of emergence and spread of artemisinin resistance in malaria-endemic countries,
      especially in Africa. In its strategy to strengthen malaria surveillance, Kenya's Ministry of
      Health (MOH) National Malaria Program (NMP) planned to conduct TES every three years to
      ascertain continuing efficacy of the first and second-line treatments. The last TES for 1st
      line treatment of malaria in Kenya was done in Siaya county in 2016. In line with the WHO
      recommendation, Jhpiego Impact Malaria project in Kenya, with funding and technical oversight
      from Center for Disease Prevention and Control (CDC) will be supporting the Kenya MOH NMP to
      conduct a TES to assess the efficacy of the current first and second line treatment policy in
      Kenya. The study is being conducted by Kenya MOH NMP, with technical oversight and funding by
      CDC through the Jhpiego Impact Malaria project in Kenya.

      Objective: To assess the efficacy of Artemether Lumefantrine (AL) and
      Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated P. falciparum malaria
      infections.

      Study Sites: One site will be selected in Siaya county and one site will be selected in
      Bungoma county (Kimilili Sub-County). Both sites will be Level-2 facilities (health centers)
      with high outpatient department attendance of patients with malaria. At each site, there will
      be two study arms: one arm for AL and one arm for DHP.

      Study Period: March 2021 to September 2021

      Study Design: This surveillance study is a two-arm prospective study Patient population:
      Febrile patients aged between 6 months and 59 months, with confirmed uncomplicated P.
      falciparum monoinfection.

      Sample Size: At each site, at least 100 patients will be enrolled per drug (200 patients per
      site, 400 patients total).

      Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a
      28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to
      evaluate DHP efficacy.

      Primary endpoints: The proportion of patients with early treatment failure, late clinical
      failure, late parasitological failure or an adequate clinical and parasitological response as
      indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase
      chain reaction (PCR) analysis.

      Secondary endpoints: The frequency and nature of adverse events.

      Exploratory endpoints: to determine the polymorphism of molecular markers of drug resistance
      and evasion of diagnostic testing; to determine the blood concentration of AL
    

Intervention name(s): artemether lumefantrine; dihydroartemisinin piperaquine
Intervention type(s): Drug; Drug
Intervention description(s): The drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria.; Antimalarial Combinations
Intervention MeSH terms: Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The two drugs being assessed are already approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatments for malaria. The study is to assess the continued efficacy of the drugs.
Masking: None (Open Label)
Primary purpose: Treatment