Pyronaridine-artesunate efficacy for the treatment of uncomplicated falciparum malaria in Cambodia
Not Applicable
Active, not recruiting
- Conditions
- Patients with plasmodium falciparum infectionInfection - Other infectious diseases
- Registration Number
- ACTRN12615000171516
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 145
Inclusion Criteria
Adults and children with body weight of 20 kg or above
- Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever 37.5 degree celcius or above
- Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
- Capability of taking an oral medication
Exclusion Criteria
- Pregnancy or lactation (urine test for beta HCG to be performed on any woman of child bearing age, that is 18 to 45 years old)
- Female aged 12-18y
- Parasitemia less than 150 000/microlitre).
- Signs or symptoms indicative of severe malaria:
- Impaired consciousness (Blantyre Coma Score less than 5)
- Severe anaemia (Hct less than15%)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of adequate clinical and parasitological response (ACPR) to the antimalarial treatment. A patient receives clinical examination and parastiological test for malaria on weekly basis over 42 days when the patient does not have malaria clinical manifestation and does not have malaria parasites in the blood the treatment outcome is classified as ACPR. [Day 42]
- Secondary Outcome Measures
Name Time Method The blood samples were collected to monitor the hepatic biological values (ALT, AST, total and conjugated bilirubin and alkaline phosphatase). These values are to be obtainable on day 0, 3, 7, 14, 21, 28, 35 and 42 by a liver function test machine at each study site. [at day 0, 3, 7,14,21,28,35 and 42]