Efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two health centres of Pointe-Noire, Republique of Congo.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001110572
• Date of registration: 21/10/2015
• Prospective Registration: No
• Primary sponsor: Ministry of Health and Populations
• Public title: Efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two health centres of Pointe-Noire, Republique of Congo.
• Scientific title: Efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two health centres of Pointe-Noire, Republique of Congo.
• Date of first enrolment: 12/09/2015
• Target sample size: 176
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001110572.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Congo

Contacts

• Name: Dr Mathieu Ndounga

• Name: Dr Mathieu Ndounga

Key inclusion & exclusion criteria

Inclusion criteria: 1. age between six months and 11 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000–200,000/microliter asexual forms;
4. presence of axillary temperature greater or equal to 37.5 degrees C 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 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. mixed or mono-infection with another Plasmodium species detected by microscopy;
4. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm)
5. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
6. regular medication, which may interfere with antimalarial
pharmacokinetics;
7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

Age minimum: 6 Months
Age maximum: 11 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

Malaria;
Malaria

Intervention(s)

To assess the efficacy and safety of artesunate+amodiaquine (artesunate 4 mg/kg body weight + amodiaquine 10mg/kg body weight once daily for 3 consecutive days) and artemether+lumefantrine (20 mg artemether and 120 mg lumefantrine in a tablet) for the treatment of uncomplicated P. falciparum infection.. The doses of artemether+lumefantrine is based on weight bands: one tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater than or equal to 35 kg; once daily for 3 consecutive days.. The treatment will be taken orally under direct supervision by the health worker. These two artemisinin-based combinations will be tested separately. The patient will be given either artesunate+amodiaquine or artemether+lumefantrine. Both of these drugs will be tested in each site. Eligibile subjects will be treated for three days and followed up for 28 days.

Primary Outcome(s)

Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.

Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.[At day 28 following initiation of artemether+lumefantrine.]

Secondary Outcome(s)

Prevalence of artemisinin resistance molecular markers (K13).

Parasite DNA extracted from the dried blood spots will be analyzed by PCR and sequencing for the presence of K13 (molecular marker for artemisinin resistance).[At Day 0 (prior initiation of treatment)]

Percent of adverse event will be documented.
The known adverse events of:
a. artesunate+amodiaquine are abdominal pain, asthenia, cough, diarrhoea, dizziness, insomnia, loss of appetite, nausea, vomiting.

b. artemether+lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting.

Parents or guardians of all enrolled patients will be asked routinely about 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.[At day 28 following initiation of treatment.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Ministry of Health and Populations

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Committe of reseach and Health Sciences

Status: Approved
Approval date:
Contact:

WHO ERC