Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh

Phase 4

• Conditions: Resistance status of artemether-lumefantrine against uncomplicated P. falciparum malaria.; Public Health - Other public health; Infection - Other infectious diseases

• Registration Number: ACTRN12612000935831
• Lead Sponsor: Ministry of Health and Family Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. All patients above 6 months of age except girls between 12-18 years and unmarried women;

2. Malaria positive P. falciparum mono-infection with parasite density of 1,000-100,000 parasites/micro-litre;

3. Axillary temperature > 37.5 degree Centigrade or history of fever during the past 24 hours;

4. Ability to swallow oral medication;

5. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

6. Informed consent from the patient or from a parent or guardian in the case of children.

Exclusion Criteria

1. Presence of general danger signs or other signs of severe and complicated falciparum malaria according to current WHO definitions.

2. Mixed or mono-infection with another Plasmodium species detected by microscopy;

3. Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference < 110 mm)

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

5. Regular medication, which may interfere with antimalarial pharmacokinetics;

6. History of hypersensitivity reactions or contraindications to the medicine being tested;

7. A positive pregnancy test or breastfeeding;

8. Unmarried women and girls between 12-18 years;

9. Unable to or unwilling to take contraceptives (for married women of child-bearing age)

Study & Design

• Study Type: Interventional
• Study Design: Not specified