Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P. vivax in Bamaw (Kachin State) and Loikaw (Kayah State).

Phase 4

Not yet recruiting

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

• Registration Number: ACTRN12611001246976
• Lead Sponsor: Defense Services General Hospital, Ministry of defense

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

*age above 13 years inclusive except females aged 14-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro liter asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/micro liter 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