pdating the efficacy study of artemether-lumefantrine for the treatment of uncomplicated P falciparum malaria in sentinel sites in the Comoros Islands.

Not Applicable

• Conditions: uncomplicated falciparum malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12613000586718
• Lead Sponsor: Ministere de la Sante, de la Solidarite et de la Promotion du Genre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

Age between 6 months to 11 years (inclusive);
Monoinfection with P falciparum, microscopically confirmed
Parasitaemia between 500-200,000 per microliter (asexual forms)
Axillary temperature equal or greater than 37.5 degrees C;
Able to swallow oral medication;
Capable and willing to fulfill protocol requirements, including the schedule of assessments for the duration of the study;
Provide written informed consent (parent or guardian)

Exclusion Criteria

Presence of general danger and signs in children under 5 years or signs of severe falciparum malaria;
Mixed or mono-infection with another Plasmodium species detected by microscopy;
History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments(s);
Severe malnutrition (per WHO definition);
Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea);
Regular medication, which may interfere with antimalarial pharmacokinetics

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)[Day 28]

Secondary Outcome Measures

Name	Time	Method
ature and incidence of adverse events as observed by investigators or reported by patients. Clinical laboratory testing may be performed to confirm a diagnosis. Possible adverse events include those know to occur with such antimalarial and include, headache, nausea, abdominal discofort, dizziness.[Day 28]