Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Palsmodium falciparum malaria in Lambarene, Gabo

Phase 4

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12616001600437
• Lead Sponsor: Ministry of Health and Population Gabon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-18
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.age 6 months to 12 years old
2.mono-infection with P. falciparum detected by microscopy;
3.parasitaemia of 1000–100,000/microliter asexual forms;
4.presence of axillary temperature greater than or equal 37.5 degrees centigrade or history of fever during the past 24 h;
5.ability to swallow oral medication;
6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
7.informed consent from the patient or from a parent or guardian

Exclusion Criteria

1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2.weight under 5 kg;
3.Haemoglobin below 8g/dl;
4.mixed or mono-infection with another Plasmodium species detected by microscopy;
5.presence of severe malnutrition (defined as a child aged 6-60 months who has symmetrical oedema involving at least the).
6.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 (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
7.regular medication, which may interfere with antimalarial pharmacokinetics;
8.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of treatment failures (early treatment failure + late clinical failure + late parasitological failure). This is a composite primary outcome.<br><br>Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses and treatment outcomes will be classified according to the WHO protocol 2009.[Primary outcome (treatment failures) will be assessed on Days 1, 3, 7, 14, 21, 28 following initiation of treatment.]