TES study

Phase 4

Recruiting

• Conditions: Malaria

• Registration Number: PACTR202301796134887

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

•age 6 months to 10 years;
•mono-infection with P. falciparum confirmed by positive blood smear;
•parasitaemia of 2000 to 200000 asexual forms/µl;
•presence of axillary temperature = 37.5 °C or history of fever during the past 24 h;
•ability to swallow oral medication;
•ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
•informed consent from parent or guardian;
•Haemoglobin > 8.0 g/dl

Exclusion Criteria

•presence of general danger signs in children aged under 11 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
•weight under 5 kg;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema. In a child aged between 6-60 months who has a mid-upper arm circumference < 115 mm;
•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);
•regular medication, which may interfere with antimalarial pharmacokinetics (Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV positive women);
•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
The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by using molecular techniques.

Secondary Outcome Measures

Name	Time	Method
Parasite clearance time, the frequency and nature of adverse events; prevalence of molecular markers of drug resistance, Day7 blood concentration of Lumefantrine.