Efficacy and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Ouesso,

Phase 4

Not yet recruiting

• Conditions: Malaria

• Registration Number: PACTR201905606150545
• Lead Sponsor: Health Ministry of Congo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. age from 6 months to 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 patient or parent/ guardian of children.

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 < 6/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 has a mid-upper arm circumference below 115 mm)
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
Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). <br>This is composite primary outcome. <br>Enrolled patients will be assessed for parasitological and clinical responses during the 28 days <br>follow-up and treatment outcomes will be classified according to the latest WHO protocol.<br>

Secondary Outcome Measures

Name	Time	Method
Percent of adverse event following treatment of each drugs will be documented. <br>The known adverse events of: <br>Atemether+lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever,<br> headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting. <br>Artesunate+amodiaquine are abdominal pain, asthenia, cough, diarrhoea, dizziness, <br>insomnia, loss of appetite, nausea, vomiting. <br><br>Parents or guardians of all enrolled children will be asked routinely about previous symptoms <br>and about symptoms that have emerged since the previous follow-up visit. When clinically<br> indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded <br>on the case report form.<br>Prevalence of artemisinin resistance molecular markers (K13). <br>Parasite DNA extracted from the dried blood spots will be analysed by PCR and sequencing <br>for the presence of K13 (molecular marker for artemisinin resistance).<br>