ACT SENSITIVITY SURVEILLANCE IN KENYA [retrospectively registered]

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201111000316370
• Date of registration: 07/09/2011
• Public title: ACT SENSITIVITY SURVEILLANCE IN KENYA [retrospectively registered]
• Scientific title: 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
• Date of first enrolment: 2010-04-08
• Target sample size: 466
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201111000316370
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Used random tables,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Kevin Omondi Onyango
• Affiliation: Senior Research Officer

• Name: John Ongecha
• Affiliation: Senior Research Officer

Key inclusion & exclusion 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: 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 b200,000 ?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


Age minimum: 6 Month
Age maximum: 59 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

The risk of PCR corrected parasitaemia following treatment

Secondary Outcome(s)

Adequate clinical and parasitological response (ACPR):

Secondary ID(s)

SSC 1682

Source(s) of Monetary Support

Ministry of Public Health and Sanitation

Secondary Sponsor(s)

Kenya Medical Research Institute