Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces of Thailand

Phase 4

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

• Registration Number: ACTRN12611000407998
• Lead Sponsor: Bureau of Vector-Borne Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age 6 months and above;
-Mono-infection with Plasmodium falciparum detected by microscopy
-P. falciparum parasitaemia of 500-1000000/ul asexual forms
-presence of axillary or tympanic temperature equal or more than 37.5C or history of fever during the past 24 h
-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 general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of 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 <110 mm) -presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest World Health Organization (WHO) guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.[Day 1, 2, 3, 7, 14, 21, 28, 35 and 42]

Secondary Outcome Measures

Name	Time	Method
The incidence of any adverse event such as nausea, vomiting, diarrhea, etc. will be documented. All patients will be asked routinely about the previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form. Serious adverse events must be reported to the sponsor.[Day 1, 2, 3, 7, 14, 21, 28, 35 and 42]