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 Gabon

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000627752
• Date of registration: 31/05/2013
• Prospective Registration: Yes
• Primary sponsor: PNLP Ministere de la Sante GABON
• Public title: 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 Gabon
• Scientific title: 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 Gabon
• Date of first enrolment: 07/06/2013
• Target sample size: 288
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000627752.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Gabon

Contacts

• Name: Dr Thierry Fandeur

• Name: Dr Dr Etienne NZENGUE

Key inclusion & exclusion criteria

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.

Age minimum: 1 Years
Age maximum: 12 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Uncomplicated Plasmodium falciparum malaria;
Uncomplicated Plasmodium falciparum malaria

Intervention(s)

This is a surveillance study to monitor the efficacy and safety of the first-line (Arsucam) and second-line (Coartem) antimalarial treatments for uncomplicated falciparum malaria in children Gabon. Eligible patients will be treated with either Arsucam or Coartem (adult tablet or pediatric dispersible tablet). Both drugs will be tested in each of the two sentinel sites; allocation to treatment will be by randomization to avoid the risk of having insufficient patients in one of the two groups at the end of the study period. Patients assigned to Arsucam will be treated with one of the three tablets strengths formulation conatining 25 mg artesunate/67.5 mg amodiaquine; 50 mg artesunate/135 amodiaquine; 100 mg artesunate/270 mg amodiaquine. Coartem tablet containing 20 mg artemether and 120 mg lumefantrine will be used in children over 15 kg, and Coartem dispersible tablets containing 10 mg artemether and 60 mg lumefantrine will be used for children from 5 to 15 kg body weight. The tablets strength and number of tablets to be administered daily will be based on body weight according to standard of care. Coartem daily dose will be administered twice a day and Coarsucam daily dose will be administered once a day. Both treaments will be administered for three consecutive days by study staff. Patients will be seen for clinical and parasitological evaluation, daily for the first 3 days, and then weekly until day 28 or at any time if symptoms re-occurred.

Primary Outcome(s)

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

Secondary Outcome(s)

Nature and incidence of adverse events. Possible adverse events are those known to occur with antimalarials and include, headache, body ache nausea, vomiting, abdominal discomfort, liver enzyme elevation and dizziness. Clinical laboratory tests may be performed to confirm a diagnosis.[Day 28]

Secondary ID(s)

None

Source(s) of Monetary Support

PNLP Ministere de la Sante GABON

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Research Committee, World Health Organisation