Efficacy and safety of a fixed combination of artemether and lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria using the sentinel surveillance system in Zimbabwe.

Not Applicable

• Conditions: ncomplicated falciparum malaria; Uncomplicated falciparum malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12613000617763
• Lead Sponsor: Ministry of Health and Child Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 724

Inclusion Criteria

Age 6 months and above;
Mono-infection with P. falciparum detected by microscopy;
Parasitaemia between 1000 to 100,000 per microliter asexual forms;
Axillary temperature equal or greater than 37.5 degrees C or history of fever within the past 24 hours;
Ability to swallow oral medication;
Ability and willingness to comply with the study protocol for the duration of the study including the study visit schedule;
Informed consent from the patient or parent
Resident within 5 km radius from study site

Exclusion Criteria

Presence of general danger signs in children under 5 years or signs of severe malaria
Mixed or mono-infection with another Plasmodium species detected by microscopy;
Presence of severe malnutrition (according to WHO definitions);
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;
Regular medication which may interfere with antimalarial pharmacokinetics;
History of hypersensitivity reaction or contraindications to any of the medicines being tested or used as alternative treatment;
Positive pregnancy test or breastfeeding (for women of child-bearing age);
Unable or unwilling to take a preganancy test or contraceptives;
Resident outside 5 km radius from study site

Study & Design

• Study Type: Observational
• Study Design: Not specified