Open-label randomised clinical trial of pharmacokinetics, efficacy, and tolerability of the fixed-dose artesunate/amodiaquine combination therapy versus both drugs administered separately for treatment of uncomplicated falciparum malaria in Kenya

Not Applicable

Completed

Conditions: ncomplicated falciparum malaria
Infections and Infestations
Malaria

Registration Number: ISRCTN16409445

Lead Sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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