Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborators: Eijkman Institute for Molecular Biology; Eijkman Institute for Molecular Biology, Jakarta, Indonesia; World Health Organization
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion criteria:

• age between one year (weight more than 5 kgs) to 65 years old;

• mono-infection with Plasmodium falciparum or Plasmodium vivax detected by microscopy;

• parasitaemia of more than 1000/μl asexual parasites for P. falciparum and more than 250/μl asexual parasites for P. vivax

• presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;

• ability to swallow oral medication;

• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and

• informed consent from the patient or from a parent or guardian in the case of children.

Exclusion criteria:

• presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO

• mixed or mono-infection with another Plasmodium species detected by microscopy;

• presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);

• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);

• regular medication, which may interfere with antimalarial pharmacokinetics;

• history of hypersensitivity reactions or contraindications to dihydroartemisinin-piperaquine

• a positive pregnancy test or breastfeeding