Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P.vivax in Myit Kyi Nar Township, Kachin State, Myanmar

Not Applicable

Completed

• Conditions: malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12610000880044
• Lead Sponsor: Department of Medical Research (Upper Myanmar), Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

*age between 6 years inclusive and above except females aged 12-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/microliter asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms)
*presence of axillary temperature equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours;
*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 signs of severe falciparum malaria according to the definitions of World Health Organization (WHO);
*mixed or mono-infection with another Plasmodium species detected by microscopy;
*presence of severe malnutrition (defined as a child whose growth standard below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 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, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(HIV/AIDS);
*regular medication, which may interfere with antimalarial pharmacokinetics;
*history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
*a positive pregnancy test or breastfeeding;
*unable to or unwilling to take a pregnancy test or contraceptives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified