Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar

Phase 4

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12611001245987
• Lead Sponsor: Department of Medical Research (Upper Myanmar)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 480

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/micro l asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/micro literl asexual forms);
*presence of axillary 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 of signs of severe falciparum malaria according to the definitions of World Health Organisation (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 below 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 Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (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