Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in the Kobeni site (provide of Hodh El Gharbi) and Timbedra (Hodgh Echargui province), Mauritania

Phase 3

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12614001107617
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age above 6 months; Mono infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection), parasitaemia between 1000 and 100000 microliters of asexual forms; measured temperature equal or great than 37.5 degrees celcius (depending on method of measurement) or history of fever within previous 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; consent to take part in the study (or parental consent/guardian consent if less than 18 years old); and the absence of severe malnutrition.

Exclusion Criteria

Signs and symptoms of severe or complicated malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition; febrile conditions due to diseases other than malaria or other know underlying chronic or severe diseases; regular medication which interferes with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to the medicine(s) being tested; positive pregnancy test or breastfeedings; unable to or unwilling to use contraception, including abstinence, for women of child-bearing age and who are sexually active.

Study & Design

• Study Type: Interventional
• Study Design: Not specified