Uncomplicated falciparum malaria Infections and Infestations Malaria
Conditions
Interventions
Patients will be equally randomised into the following treatment groups:
Group A: fixed-dose AS/AQ combination tablets (100 mg/270 mg), two tablets once daily for three consecutive days.
Group B: AS t
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults from 18 to 60 years of age; either gender 2. Presenting with acute uncomplicated falciparum malaria: 2.1. Oral temperature greater than 37.5°C, or 2.2. History of fever in the last 24 hours 3. Positive P. falciparum parasitaemia (greater than 1000 asexual parasites/µL) 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Any other concomitant febrile illness, e.g. upper respiratory tract infection or Ear, Nose and Throat (ENT) infection 2. Features of severe malaria 3. Mixed Plasmodium infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to investigate the pharmacokinetic properties of fixed-dose combination AS/AQ. Blood sampling will be performed at predefined time points in both groups of patients. The evaluation of pharmacokinetics variables will take place over the three-day treatment and the entire follow-up off-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment outcomes: the classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest (2005) guidelines of World Health Organisation (WHO). Accordingly, all patients will be classified as having an Early Treatment Failure, a Late Clinical Failure, a Late Parasitological Failure, or an Adequate Clinical and Parasitological Response 2. Safety variables: the occurrence of any adverse event will be documented. All patients will be routinely asked about old symptoms and new symptoms emerging since previous visit during follow-up | — |
Countries
Kenya
Outcome results
None listed