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ACT SENSITIVITY SURVEILLANCE IN KENYA [retrospectively registered]

An open-label randomized study evaluating the efficacies of artemether-lumefantrine (ART/LUM®) and dihydroartemisinin/piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in children under five years of age under different epidemiological settings in Kenya

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201111000316370
Enrollment
466
Registered
2011-09-07
Start date
2010-03-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Paediatrics

Interventions

Sponsors

Kenya Medical Research Institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Presentation to the Health facility with probable clinical malaria. 2. Presence of fever ¿ 37.50C (axillary) 3. Aged between 6 and 59 months, inclusive 4. Weight ¿ 5 kgs 5. Mono-infection with P.falciparum at an asexual parasite density of 1000 ¿ 200,000 parasites per ¿l in malaria 6. Not suffering from severe and complicated forms of malaria (according to WHO, 2000 classification) 7. Able to take drugs under study by the oral route 8. Parent or guardian gives an informed written consent to participate in study

Exclusion criteria

Exclusion criteria: 1. Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb ¿5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (parasites >200,000 ¿l). 2. General clinical condition calling for hospitalization 3. Evidence of concomitant infections/disease at the time of presentation 4. Past or present history of chronic illnesses or any other underlying illness that would compromise the diagnosis and evaluation of the response to the study drug 5. History of allergy to artemisinin, lumefantrine or piperaquine 6. Full treatment with other antimalarial drugs within the past 14 days

Design outcomes

Primary

MeasureTime frame
The risk of PCR corrected parasitaemia following treatment

Secondary

MeasureTime frame
Adequate clinical and parasitological response (ACPR):

Countries

Kenya

Contacts

Public ContactJohn Ongecha

Senior Research Officer

michaelongecha@yahoo.com+254733447920

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Mar 21, 2026