Efficacy and safety of the fixed combinations of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Melen (Estuary) and of Franceville (Haut Ogooue) in Gabo

Not Applicable

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

• Registration Number: ACTRN12613000627752
• Lead Sponsor: PNLP Ministere de la Sante GABO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours.
Parasitemia, asexual forms between 2000 and 200 000 per microliter of blood.
Mono-infection with plasmodium falciparum confirmed by microscopy.
Age between 12 months and 12 years.
Body weight greater than 5 kg.
Absence of clinical signs of severe malaria
Absence of known serious chronic disease.
Absence of severe malnutrition.
Capacity to swallow oral medication.
Capable and willing to follow protocol requirement including schedule of assessments
Consent from parent or guardian.
Assent from children aged 11 and 12 years.

Exclusion Criteria

Presence of general danger signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition.
Mixed or mono-infection with another Plasmodium species detected by microscopy.
Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z-score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm.
Presence of febrile conditions due to diseases other than malaria (measles, acute lowest respiratory tract infection, severe dirrhoea with dehydration) or other known underlyning chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS).
Regular medication, which may interfere with animalarial pharmacokinetics;
History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatments
Likehood of pre-pubescence or pubescence in female.
Refusal to consent.
Not capable to comply with visit schedule.

Study & Design

• Study Type: Observational
• Study Design: Not specified