Evaluation of therapeutic efficacy and safety of artesunate-amodiaquine, artemether-lumefantrine and dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum in Democratic Republic of Congo

Phase 4

Completed

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

• Registration Number: ACTRN12616001423404
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

1. age between six to 59 months;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 2000–200,000/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. Haemoglobin < 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 has a mid-upper arm circumference belo 115 mm)
6. 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);
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). This is composite primary outcome.<br><br>Enrolled patients will be assessed for parasitological and clinical responses during the 42 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.<br>[At days 1, 2, 3, 7, 14, 21 and 28 following artesunate+amodiquine or artemether-lumefantrine treatments; and days 1, 2, 3, 7, 14, 21 and 28, 35 and 42 following dihydroartemisinin-piperaquine treatment.]